IT Support and Hardware for Clinics
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IT Support and Hardware for Clinics
News, Information and Updates on Hardware and IT Tools to help improve your Medical practice
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Things to consider when upgrading your computers

Things to consider when upgrading your computers | IT Support and Hardware for Clinics | Scoop.it

The health industry is continuing to grow with massive investments in technology and related processes to meet today’s industry needs for increased collaboration, cross-entity, and platform integration as well as the need to achieve more by doing less. Those factors highlighted above have prompted the need for health businesses to invest in implementing IT solutions, which for the health industry fall under the eHealth banner.

 

Through our experience in implementing IT platforms for different size health businesses, we would like to share the top ten tips to save you time, money and potential headaches.

 

Technology makes your life easy: This is the main reason why we have the technology and invest in IT solutions. You need to know why you need to implement a new IT solution and appreciate that change is coming. Whether it’s changing from a paper-based system to a paperless system or complying with new industry standards, IT solutions will allow you to continue your clinical work and help minimize the administration cost. Make sure you know why you are implementing a new IT solution and set the expectations straight away.

 

Ask for a solution design proposal: As a specialist eHealth/IMIT firm we design new solutions for health businesses every day. No business is the same and no IT solution is the same. eHealth professionals know the industry requirements, they know the technology lifecycle and will know what works for your business. Ask an expert to design and scope an IT solution tailored for your business. Call different IT providers and ask them to provide their own solution/design. This way you will have options to choose from.

 

Don’t cut corners with the server: Simply the most important aspect of a clinical IT environment. The server will host your business, clinical and billing data. The server ensures that you and your staff have access to all the relevant tools and data to keep on working. Ensure that your server is a brand name (NOT PUT TOGETHER USING DIFFERENT BITS AND PIECES), ensure the server comes with at least a three-year warranty (or purchase an extension)and, most importantly, ensure that the server can handle business and data growth. You are thereby futureproofing your IT environment.

 

Technicalities of the server: Again, no business is the same. However, there is a common denominator when looking for a small/medium size server. Ask for:

  • Quad core CPU (Xeon processor) for future application/data load
  • 16GB RAM to handle more users, data, and load
  • RAID 1 configuration using SAS drives to ensure that should the hard drive fail, there is a second one to take over
  • Dual power supply to ensure the server keeps working should the primary power supply fail (it happens)
  • UPS to protect your server and data should a power outage occur
  • Windows server operating system to run your applications, store your data and ensure a secure platform

 

Backup and disaster recovery: Backup solutions ensure that your business/clinical data is safe and can be recovered should there be any data loss. Having said that, the ability to recover the data quickly and efficiently is just as important. The correct disaster recovery solution will save you a lot of time and money. Below is a quick solution guide that you can use:

 

  • Buy an imaging software like Shadow Protector Backup Assist. Ask for a daily image of your server to be implemented
  • Use USB 3.0 hard drives to back up your image (from above) and clinical data. Rotate the hard drive on a daily basis
  • Use USB thumb drives to back up the clinical data only and rotate daily

 

What about the workstations?: Easy. If the server solution is: Terminal server: Ask for thin client terminals also known as dummy terminals. Those are devices without any hard drives and connect directly to the server. Standard server/workstation environment: We recommend i5 dual-core processors with 8GB RAM and Windows 7 64-bit (do not purchase anything older than Windows 7)

 

The implementation: Ensure hiring of an IT firm that specializes in the health industry. They will liaise with the different software vendors, pathologies and ensure that your new IT environment meets the RACGP standards so you can get accredited. Remember to also ask the IT firm to ensure that your practice meets the new e-PIP requirements. Most importantly, ask the IT firm to provide a project plan and an implementation plan with deadlines on when you will obtain the hardware, the time to implementation and handover dates.

 

Security tips: This is quite simple. Ask for a top brand antivirus program to be installed and configured on all devices. I tend to recommend ESET NOD32. Ask for the network to be set up as a domain and not a workgroup. Ask for different user groups (staff, management, administrators) where the staff isn’t allowed to install any software, management can install on the workstations and administrator group has full access. Set up each user with their own password and ask them to change it every three months. Avoid Wi-Fi and use standard LAN.

 

Remote login: Do you work from different locations (aged care visits, home visits) and would like to access your clinical IT environment? There are a number of options that we recommend, one being implementing a VPN (Virtual Private Network) or an RDP (Remote Desktop Protocol configuration). Your IT provider will advise on the best solution. However, you must be sure to tell them that you wish to log in remotely before committing to any hardware/solution.

 

All businesses are different and as such, IT solutions will differ per business requirements, size and budget. The most important thing is to ensure that the server has at least a three-year lifecycle and have the selected solution implemented by professionals. This will save you time and money in the future.

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3 Cisco Cloud Security Products to Check Out 

3 Cisco Cloud Security Products to Check Out  | IT Support and Hardware for Clinics | Scoop.it

Cisco continues to evolve its cloud security profile with new developments from Meraki, Umbrella and Duo products. These three products are made to seamlessly integrate with your systems to better protect your business. Learn more about each below.

Cisco Meraki

Cisco Meraki combines security cameras, cloud-management, and analytics with the MV lineup. The MV22 and MV72 cameras provide reliable security. They are easy to set up and manage through the Meraki dashboard. This tool eliminates the single point of failure, so you don’t have to worry about one camera failing and taking down the whole system. Both models have 256GB of solid states storage and up to 1080 pixels of high definition resolution. The Meraki dashboard allows for monitoring and management of all cameras from anywhere in one or multiple locations with no extra software required. The dashboard uses analytics to provide valuable insights to protect your business. An example is performing a motion search, which can detect people using pixels at certain periods of time during the day. Additionally, under the Meraki brand, the Meraki SD-WAN is 100% centralized cloud management for security, networking and application control. The dashboard enables network admins to view networked clients, bandwidth consumption, and application usage across all sites. Some of its features include no external modem, high availability, and advanced security license/firewire.

Cisco Umbrella

Cisco Umbrella Solution is a cloud-based secure internet gateway and provides the first line of defense from threats on the internet – even if the end-user is working remotely from a company device or their own computer. The Umbrella boasts an easy deployment and an even easier system to operate. It integrates directly with Meraki products and the rest of the Cisco security profile. With Umbrella, users are protected anywhere they access the internet with or without a VPN. The DNS is the biggest threat to security and most of the time isn’t monitored. The Umbrella Cloud Solution solves this gap as the first line of defense. It not only solves requests, but it also looks at comparisons in the data to better detect similar threats from cyber fingerprints used by attackers.

Duo

The duo is the most recent addition to the Cisco family. This tool offers a streamlined way to improve the user experience during the multi-factor authorization while also protecting your business. The duo takes it a step further by checking devices managed and unmanaged to ensure it meets security standards before granting access. 


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The dangers of autocomplete passwords

The dangers of autocomplete passwords | IT Support and Hardware for Clinics | Scoop.it

Hackers have found a new way to track you online. Aside from using advertisements and suggestions, they can now use autocomplete passwords to track you down. Feeling insecure? Here are some ways to keep you out of harm’s way.

Why auto-fill passwords are so dangerous

As of December 2018, there are 4.1 billion internet users in the world. This means users have to create dozens of passwords, either to protect their account or simply to meet the password-creation requirements of the platform they’re using. Unfortunately, only 20% of US internet users have different passwords for their multiple online accounts. 


Certain web browsers have integrated a mechanism that enables usernames and passwords to be automatically entered into a web form. On the other hand, password manager applications have made it easy to access login credentials. But these aren’t completely safe.


Tricking a browser or password manager into giving up this saved information is incredibly simple. All a hacker needs to do is place an invisible form on a compromised webpage to collect users’ login information.

Using auto-fill to track users

For over a decade, there’s been a password security tug-of-war between hackers and cybersecurity professionals. Little do many people know that shrewd digital marketers also use password auto-fill to track user activity.

 

Digital marketing groups AdThink and OnAudience have been placing these invisible login forms on websites to track the sites that users visit. They’ve made no attempts to steal passwords, but security professionals said it wouldn’t have been hard for them to do. AdThink and OnAudience simply tracked people based on the usernames in hidden auto-fill forms and sold the information they gathered to advertisers.

One simple security tip for today

A quick and effective way to improve your account security is to turn off auto-fill in your web browser. Here’s how to do it:

  • If you’re using Chrome – Open the Settings window, click Advanced, and select the appropriate settings under Manage Passwords.
  • If you’re using Firefox – Open the Options window, click Privacy, and under the History heading, select “Firefox will: Use custom settings for history.” In the new window, disable “Remember search and form history.”
  • If you’re using Safari – Open the Preferences window, select the Auto-fill tab, and turn off all the features related to usernames and passwords.

This is just one small thing you can do to keep your accounts and the information they contain safe. 

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3 Smart Ways To Prevent A Cyber Attack

3 Smart Ways To Prevent A Cyber Attack | IT Support and Hardware for Clinics | Scoop.it

Over half (55%) of small to medium sized businesses were victims of cyber attacks within the last 12 months. That being said, it’s more important than ever for small businesses to stay vigilant and avoid a cyber attack at all costs. Here are just a few expert tips to help your business prevent a cyber attack or security breach.

 

Create And Enforce Internal Security Policies
It may sound surprising, but a great number of business security breaches actually occur within the business itself as opposed to originating from an external threat. Usually, this will occur when an employee clicks on a link in an email that contains phishing software. Other times, employees simply use poor passwords that are easily guessed. That’s why educating your employees and forming clear security policies is the first step to gaining control of your IT security. Keep all employees on the same page regarding password protections and provide quarterly training sessions to keep employees updated with the latest security information.

 

Don’t Ignore Update Requests
Your employees have probably done this before — instead of letting their computers update as usual, they’ll keep delaying the process because it’s just not a convenient time for an update. This can weaken your business’s security and prevents your business from achieving true IT optimization and efficiency. Make sure all your employees are paying attention to their update notifications and are installing and implementing updates as soon as possible after they become available.

 

Consider A Managed Services Provider
In addition to taking the previous two preventative measures, your business should also highly consider investing in reliable IT management such as a managed services model to optimize computer network maintenance and greatly reduce or even effectively eliminate the possibility of a cyber attack. In fact, for 38% of companies of all sizes, enhanced security and compliance was the reason for using a managed services provider. Yes, hiring an IT service provider does require an additional investment, but for many businesses, the peace of mind that accompanies is absolutely priceless — not to mention the money and frustration you may be saving if a cyberattack were to occur.

 

Ultimately, knowing how to keep your business’s IT infrastructure as secure as possible is the key to preventing a cyber attack. For more information about IT service providers, contact Manhattan Tech Support.

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Cloud Computing Supports Telemedicine Growth

Cloud Computing Supports Telemedicine Growth | IT Support and Hardware for Clinics | Scoop.it

Today’s healthcare professionals enjoy convenient access to a multitude of tools that would have amazed previous generations. Unfortunately, lack of awareness or access to technical experts means that many practices are unable or unwilling to take advantage of the latest technological advances, advances that increase efficiency, security and productivity. Others are intimidated by the technical jargon often associated with eHealth. All that is needed to eliminate all these issues is a partnership with a provider that specialises in the health industry, rather than deal with IT companies that are themselves unwilling to recommend healthcare-specific solutions that they are unfamiliar with.

 

Providers of healthcare solutions are familiar with the inner workings of practices and clinics and can easily review existing processes and recommend solutions that will integrate technology in the best possible manner. They will also support any new technological solutions, leaving medical professionals more time for patient care, which will ultimately provide substantial benefits that aid early diagnosis and prolong lives.

 

Providers without healthcare knowledge will recommend solutions that they are familiar with, ones that are normally selected by traditional commercial enterprises. Such solutions are generally unsuitable for healthcare clinics and practices and often require expensive customisation, assuming that they can even be customised sufficiently to meet existing regulations.
Smaller clinics and practices do not have an on-site IT team and often eliminate IT requirements by automating server maintenance, data backups and archiving using a cloud solution. In such a scenario, it is the provider that is responsible for all of these activities.

 

Telemedicine allows easier collaboration and involves the use of mobile or other internet-enabled devices. Advantages include instant videoconferencing, remote consults, immediate access to electronic health records and the elimination of geographical issues, where patients are unable to visit the practice or clinic in person. These collaborative features are used between medical teams in multiple locations, between mobile clinics and their headquarters and of course can be used by any medical professional on the move.

 

When cloud services are used, connectivity is possible from anywhere a broadband signal is present, whether to a PC or portable device. This is ideal for patients in remote are rural areas and eliminates the time and expense necessary to consult with a specialist in the traditional manner. With videoconferencing, for example, no travel is required yet an excellent service is provided by the healthcare professional involved. Even follow-ups are possible online. Security concerns are also eliminated as a travelling professional accesses data remotely and never stores it on their own personal devices.

 

There are additional cloud benefits for healthcare professionals and these include:


• Scalability – you pay for the amount of space you use and it can be increased on demand


• Automatic updates – the provider’s IT team install security patches promptly


• Disaster recovery – automated regular backups take place and are restored when active data is lost


• Redundancy – multiple broadband connections are available. When one fails, another takes over


• Flexibility – if additional bandwidth is needed, it is readily available. This is not possible with traditional networks


• Works from anywhere – an internet-ready device, a 3G or broadband connection and you are good to go


• Collaboration – depending on requirements, there are specific software applications available to aid collaboration between team members and patients


• Document management – a single document repository allows secure and controlled access to confidential information


• Security – the use of the cloud ensures data is never stored in portable devices, given that thousands are lost or stolen every year

 

• Green-tech – the carbon footprint for each practice or clinic is substantially reduced, with cloud servers using less power per client due to virtualisation technology


• Cost savings – every clinic and practice uses the latest in hardware and software technology but without the initial investment. Ongoing IT maintenance costs are also dramatically reduced

 

When it comes to telemedicine, in addition to data management and document control features, there are software applications available that maximise patient turnover per clinic, improve patient care and even improve follow-up treatment and remote monitoring processes.

 

With benefits of this magnitude and with evolving regulations to embrace technological advances in eHealth, clinics need to install a telemedicine solution sooner rather than later or give competitive advantage to those that adopt now. This is especially true if patients and colleagues are in other geographical areas. In fact, government services are already active for eligible aged-care homes and to patients of Aboriginal Medical Services throughout Australia.

 

 

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The Promising Future For AI In Orthopedics

The Promising Future For AI In Orthopedics | IT Support and Hardware for Clinics | Scoop.it

In their most simple form, AI applications in healthcare consist of a collection of technologies that will enable machines to sense, comprehend, predict, act, and learn. The first application for AI-based machines, as discussed at the World Medical Innovation Forum (held in April 2018), is to execute healthcare administrator and clinical healthcare functions. Current technologies are limited because they are algorithm based. The future of AI will make the leap past algorithm-only tools to become indispensable instruments for patients, providers, physicians, and payers. AI has the potential to truly augment human activity.

 

Why This Is Important
The potential to drive improvements in quality, cost, and access has made AI a notable buzzword in healthcare. The AI health market is growing rapidly and is forecasted to reach $6.6 billion by 20211 (Table 1).

 

AI Applications in Orthopedics
AI has demonstrated high utility in classifying non-medical images. A study2 looked at the feasibility of using AI for skeletal radiographs. The study authors compared an AI program against the radiography gold standard for fractures. They also compared the performance of the AI program with two orthopedic surgeons who reviewed the same images. They found the AI program had an accuracy of at least 90 percent when identifying laterality, body part, and exam view. AI also performed comparably to the senior orthopedic surgeons’ image reviews. The study outcomes support the use of AI in orthopedic radiographs. While the current AI technology does not provide important features surgeons need, such as advanced measurements, classifications, and the ability to combine multiple exam views, these are technical details that can be worked out in future iterations for the orthopedic surgeon community.

 

AI in Computer-Assisted Navigation3
Orthopedic surgeons have had access to robotic technology to help them position screws, prostheses, or tunnels for some time, but AI enhanced applications are in development (Table 2). For example, one device utilizes infrared light to locate bones intraoperatively. Another technology uses a form of AI to mill the canal for a prosthesis based on CT scans. In total hip surgery, computer assistance in placing the cup of the prosthesis is reported to have the same accuracy as with traditional methods. In the realm of knee replacement surgery, AI-supplemented robotics technology assists to align prostheses. In spine surgery, AI-enhanced computer-assisted navigation helps surgeons avoid neurovascular structures, and place thoracic and lumbar pedicle screws accurately. It is reported that the incidence of poorly placed screws has reached 42 percent with conventional surgical techniques, according to some studies, but is as low as 10 percent with AI-based computer assistance.

 

We Have Needed a Tool Like AI for a Long Time
AI will change the way healthcare work is performed. AI will fill the gaps we all know are coming in the future, such as the labor shortage in healthcare (Table 3). Through AI, we will empower clinicians and give workers tools to increase their productivity. Healthcare institutions will need an AI-trained workforce and culture. Think of the value your products will bring with AI and the ability to gain clinician face-time and recognition as they use AI to enhance efficiency, quality, and outcomes.

 

The Medi-Vantage Perspective
In almost every strategy research project we manage, when we look at adjacent technologies in consumer markets, we see AI being utilized again and again. Our strategy research helps clients understand the opportunity to integrate AI technology into their product strategies. Someday, even the most common medical devices will have an AI component.

 

Maria Shepherd has more than 20 years of leadership experience in medical device/life-science marketing in both small startups and top-tier companies. After her industry career, including her role as vice president of marketing for Oridion Medical where she boosted the company valuation prior to its acquisition by Covidien/Medtronic, director of marketing for Philips Medical, and senior management roles at Boston Scientific Corp., she founded Medi-Vantage. Medi-Vantage provides marketing and business strategy as well as innovation research for the medical device industry. The firm quantitatively and qualitatively sizes and segments opportunities, evaluates new technologies, provides marketing services, and assesses prospective acquisitions. Shepherd has taught marketing and product development courses and is a member of the Aligo Medtech Investment Committee (www.msbiv.com). She can be reached at 855-343-3100, ext. 102, or at mshepherd@medi-vantage.com. Visit her website at www.medi-vantage.com.

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Physicians are not Experts, they rely on their Health IT Vendors for Support and Security Guidance 

Physicians are not Experts, they rely on their Health IT Vendors for Support and Security Guidance  | IT Support and Hardware for Clinics | Scoop.it

Medicine has its own version of a digital divide. In terms of cybersecurity accountability, the buck stops with the physician. The problem is that security expertise lies with information technology (IT) vendors who provide software, equipment, training and other services to physician practices. These vendors often speak a different language than the physician, who is well versed in clinical matters but whose tech savvy may end with the cable TV remote.

 

“Physicians are not security experts. It’s not what they went to school for,” said Laura G. Hoffman, assistant director of the AMA’s department of federal affairs, and presenter on two recent AMA cybersecurity training webinars. Because physicians are not experts, they “rely on their health IT vendors for support and security guidance.”

 

A recent AMA-Accenture survey of 1,300 physicians found that more than a quarter of physicians already outsource their security management and an almost equal number are interested in doing so. Many physician practices go it alone—about half of the practices surveyed have an in-house security official—juggling the requirements of various systems and equipment, and relying largely on trust that the products and services they pay for are secure, reliable and work seamlessly together.

 

“Physicians really trust their vendors and that can be good and bad,” Hoffman said. Under the Health Insurance Portability and Accountability Act (HIPAA), she noted, it’s physicians who “are the ones on the hook if anything goes wrong.”

 

Bridging medicine’s cybersecurity digital divide can be an intimidating prospect, especially for smaller practices. How products from various vendors fit together may be unclear. The scope of a physician’s discussion with a vendor will vary greatly by not only by practice size, but by technology choices. For example, a practice with cloud-based records storage will have different concerns to address than one with its own server. Here is what to consider for having a more effective conversations with vendors.

 

Think ePHI and beyond, not just EHR. A medical practice’s starting point for getting a handle on vendors might be the electronic health record (EHR), but cybersecurity preparedness and accountability requires a broader view. In terms of cybersecurity, HIPAA covers any and all electronic protected health information (ePHI). An EHR is sure to contain ePHI, but ePHI is likely to be found throughout the practice. HIPAA requires a security risk analysis and whether done in-house or by a vendor, it is a great starting point for getting an inventory of all the relevant technology and understanding the interactions of the devices involved.

 

The AMA offers a free, one-hour webinar to familiarize physicians and practice managers about how to conduct it. Beyond obvious HIPAA concerns, there is other technology—for example, non-EHR office software and computers—that can play a role in the safe and smooth functioning of the practice. “Identifying the actual technology in your environment is a first step in making sure everyone is at the table when you have these conversations,” said AMA Senior Health IT Consultant Matt Reid, co-presenter with Hoffman in a separate AMA webinar on cybersecurity and patient safety.

 

Practices need to be more assertive. Technology from different vendors may not always smoothly mesh. For example, a larger practice with cloud-based records storage requires an Internet service provider to supply sufficient Internet bandwidth to reliably store and retrieve data.

 

What’s required is a practice cybersecurity and technology “champion,” said Reid. It is that individual—who may well be a practice staff member as opposed to a physician—who can get vendors together, face to face or in a conference call, to have all the practice’s technology work together. According to Reid, the he champion’s message should be: “This is an issue where we all want to row in the same direction, so how are we all going to work together cohesively?”

 

Vendors need to be more forthcoming. When that practice champion gets the conversation going, a top priority is collecting and sharing a complete set of technical information from all of the practice’s health IT vendors. The objective is to find out fully what the practice needs to know about and, critically, what the vendors need to know about each other’s hardware, software and services requirements.

 

Testing is essential. A practice should periodically test the technology it relies on—Hoffman noted one example of an EHR that, unbeknownst to the practice, ran out of storage space—and be aware that technology problems can arise whenever anything new is added to the mix.

 

Looking ahead, the AMA is exploring how practices can be incentivized to work closer with vendors on cybersecurity. Nearly three-quarters of the doctors in the AMA-Accenture survey said they would be willing to pay a vendor to implement a cybersecurity framework if adoption meant that practices would not be subject to random HIPAA audits.

 

Also on the AMA’s advocacy list: safe-harbor exemptions from the Stark Law and Anti-Kickback Statute expanded to allow donation of cybersecurity-related hardware or software to small medical practices from other provider groups. The AMA recently sent a letter to the U.S. Department of Health and Human Services’ Office of Inspector General on the matter.

 

In the letter, the AMA expressed its deep concern that the country’s health care providers have been insufficiently prepared to meet the cybersecurity challenges of an increasingly digital health system. The AMA firmly believes that this is a national priority and that physicians and other health care providers need tools to secure sensitive patient information in the digital sphere.

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Advanced Software Offers Metal Artifact Reduction For Extremities

Advanced Software Offers Metal Artifact Reduction For Extremities | IT Support and Hardware for Clinics | Scoop.it

Carestream Health will demonstrate new optional advanced metal artifact reduction software for its Carestream OnSight 3D Extremity System at the Radiological Society of North America tradeshow (Booth #6713). Carestream’s OnSight 3D Extremity system captures high-quality, low-dose 3D extremity exams. The company’s new metal artifact reduction software is pending FDA 510(k) Clearance.

“Carestream’s second generation of software takes our state-of-the-art original metal reduction software to a new level. It provides enhanced flexibility depending on the metal content present and reduces the visual distortion caused by screws, implants, rods and other metal objects to create improved visibility and diagnostic confidence,” said Helen Titus, Carestream’s worldwide marketing director for ultrasound & CT.

The optional software makes it easier for radiologists and orthopedic surgeons to accurately diagnose a patient’s condition and develop treatment plans. Image processing can be adjusted and optimized according to the amount of metal present.

The software uses information from the original scan to eliminate the need for additional imaging studies, which reduces costs and lowers radiation exposure for patients.

An intuitive touch screen interface allows technologists to adjust for either moderate or complex metal content. The metal artifact reduction software can be activated prior to the scan or it can be applied after the original reconstruction is complete. Both the original and corrected images are always available to view and compare.

The OnSight 3D Extremity System also assists surgeons in detecting occult and non-union bone fractures. Unlike traditional CT systems, this cone beam CT system has a large-area detector that captures a 3D image of the extremity in a single rotation, which takes only 25 seconds. A patient simply places the injured extremity into a donut-shaped opening in the system. Since the patient’s head and body are not confined, patients do not experience the claustrophobia that often occurs with traditional CT systems. Dose is significantly reduced because only the affected body part is imaged.

The compact extremity system can be installed in an exam room and plugs into a standard wall outlet.

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Why Firms Of All Sizes Need To Outsource? 

Why Firms Of All Sizes Need To Outsource?  | IT Support and Hardware for Clinics | Scoop.it

I was working as a product development engineer at AcroMed (a spinal implants manufacturer that was acquired by DePuy in 1998), when I noticed a gap in the medical device industry. There were plenty of companies coming up with great ideas for devices, but there were holes in the product development cycle thanks to a lack of resources or expertise.

 

That’s when I decided to grab a shovel and start filling some of those holes. First came Empirical Testing Corp. (ETC), which focused on testing devices. It was all we did, so we got good at it over the course of 20 years. Through ETC, we heard from clients who needed small-batch manufacturing and prototyping, so we launched Empirical Machine. Clients came to us for regulatory support through both of those specialty companies, so we added Empirical Consulting to our group of companies. Each branch of our corporate family tree developed as an answer for companies or individual developers lacking a critical in-house resource.

 

For companies large and small, outsourcing specific aspects of device development builds forward momentum and supports the entire industry.

 

Andy Fauth is an engineer by training. For 13 years, he’s worked in a private-equity, privately owned business he says owes its growth to finding the right vendors. He’s now chief technology officer for SMV Scientific, a company that specializes in the bone-implant interface and designs, develops, and manufactures orthopedic devices. The company began as a two-person research and development venture four years ago and has grown into a 17-person business with three devices on the market and six 510(k)s completed.

 

“As an emerging company, we don’t have the capital to have the equipment internally or hire everybody we’d like to hire for the right way to handle this stuff,” he said. “The only way we could incubate this company and grow was to outsource.”

 

Even for larger companies, it often makes sense to outsource specific parts of device development, he said.

 

“There’s always a bottle neck somewhere—that’s why there is an outsource market,” Fauth said. “Some of that stuff is specialty. When you’re going to do it once every couple of years, you don’t want to do that internally. There’s always specialty equipment, whether it’s a test frame or test fixture or experience with a certain protocol you don’t have in-house, or don’t want to invest in having that in-house long-term. You just need to use it once and check the box.”

 

Raymond Cloutier, vice president, Engineering & Development, Advanced Technologies at Exactech, said despite significant resources and commitment to Exactech’s in-house resources, he also turns to outside vendors for specialized support. Sometimes it’s an issue of capacity, but he also appreciates the benefits of outside expertise.

 

“[Outside vendors] are in a somewhat privileged position,” he said. “They’re also doing work for other companies, which helps them know the benchmark or industry standard. Sometimes when we’re in our own world as a company, we don’t have as much understanding of how requirements should be interpreted. An outside consultant may better understand what expectations, for example, the FDA may have. Suppliers generally have seen how multiple companies prepare submissions.”

 

He said bigger companies may, at times, err on the side of being overly cautious.

 

“Oftentimes large companies take very conservative positions because they have a lot at stake,” Cloutier said. “The question is, are they being ‘overly compliant’? Are they doing things more rigidly than what the external regulatory bodies require? Sometimes an outside perspective helps you better know the answer to that.”

 

David Poirier is founder and owner of spinal implant company Presidio Surgical, which has a staff of eight. He keeps quality control, marketing, sales, distribution, and accounting in-house, but the bulk of his device development work depends on outside vendors.

 

“Everything we do, we pay for through sales and distribution of our products,” Poirier said. “They have to be right. There’s really no room for error. We’ve made errors. They hurt.”

 

At first glance, it may appear outsourcing is more expensive than keeping things under your roof. But those numbers can be misleading. You may pay $200 per hour to a single vendor—which is often more than an employee’s hourly wage—but you’re not paying benefits or down time when the employee is not actively engaged on the project, Poirier said. There’s also a matter of prioritizing in-house expertise to make the best use of time and money, he said.

 

“If I take someone in quality engineering and say, ‘I need you to work on this gauge design,’ my project may have a mid-level priority, but I’ve taken them from a much higher-level project; there’s an opportunity cost,” Poirier said. “There’s the cost of the benefits and true cost of employees, then the opportunity cost. It’s a general management issue you have to think about. With consultants, you’re only paying them for what they deliver instead of the full cost (of an employee).”

 

Paying for support a la carte is less expensive than developing that service for your business, Poirier said.

 

“I only pay them for the work they do,” he said. “When you’re outsourcing, it can be a benefit if you have really good experts. You’re paying them for what you want and get what you need. You’re paying for specific service rather than a staff member. It’s hard to find good people.”

 

Working with consultants who are well-known in the industry has its advantages, Fauth said.

 

“Just to get the expertise for third-party validity for our customers, we’d outsource,” he said. “We actually had to challenge and re-invent new standards. We worked with the FDA to develop protocols and standards that didn’t exist at the time. When you have an outsource company that’s done all of that already and has a reputation of being a good firm, it lends a lot of credibility and merit to what you’re trying to do.”

 

Word-of-mouth referrals and networking are solid first steps toward finding the partner.

 

“Reputable is the key,” Cloutier said. “One test that gives me an indication is how careful they are at protecting other companies’ knowledge. If they share confidential information from other companies with you, then they’re probably sharing your confidential information with others. Observing this helps me judge who is a trustworthy supplier to work with and who isn’t.”

 

And even as you consider outsource options for aspects of your project, never forget the big picture, Fauth said.

 

“I look at anybody we interact with as a potential partnership, not just a customer/supplier relationship,” he said. “If something goes bump in the night, I want everyone equally committed to fixing it.
I also want it to be a win for both parties. That’s the right way to do business long-term. It’s not always about price or lead time. Those are factors. It’s also about quality, it’s about trust, it’s about faith they’re going to make it right if something goes wrong and everybody’s going to work for everybody else’s best interest.”

 

Dawn Lissy is a biomedical engineer, entrepreneur, and innovator. Since 1998, the Empirical family of companies (Empirical Testing Corp., Empirical Consulting LLC, and Empirical Machine LLC) has operated under Lissy’s direction. Empirical offers the full range of regulatory and quality systems consulting, testing, small batch and prototype manufacturing, and validations services to bring a medical device to market. Empirical is very active within standards development organization ASTM International and has one of the widest scopes of test methods of any accredited independent lab in the United States. Because Lissy was a member of the U.S. Food and Drug Administration’s Entrepreneur-in-Residence program, she has first-hand, in-depth knowledge of the regulatory landscape. Lissy holds an inventor patent for the Stackable Cage System for corpectomy and vertebrectomy. Her M.S. in biomedical engineering is from The University of Akron, Ohio.

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EMPOWR Porous And Complex Primary Knee Systems

EMPOWR Porous And Complex Primary Knee Systems | IT Support and Hardware for Clinics | Scoop.it

DJO, a provider of medical technologies designed to get and keep people moving, introduced the EMPOWR Porous Knee System and EMPOWR Complex Primary Knee System at the 2018 Annual Meeting of the American Association of Hip and Knee Surgeons (AAHKS). These new additions to the EMPOWR Knee Platform expand one of the industry’s most modern total knee replacement systems, which now offers primary, cementless primary, complex primary, and tibial revision solutions for surgeons and patients.

EMPOWR Porous Knee System is based on two decades of clinical experience and highly porous materials designed to enhance early implant fixation, while creating an ideal environment for both immediate and long-term biologic fixation.1 DJO’s surface coating technologies, including DJO’s proprietary, highly porous coating, P2 aids in bone apposition for superior in-growth performance.1 EMPOWR Porous’ bladed keel has a bone sparing geometry optimized for cementless application.2 The bladed keel of the asymmetric baseplate was developed to provide robust fixation, while the cruciform pegs provide initial component fixation and durable rotational stability.2

EMPOWR Complex Primary Knee System, with the EMPOWR Universal Tibial Baseplate and EMPOWR Varus Valgus Constraint (VVC) Tibial Insert expand the utility of the EMPOWR Knee Platform and provide a wider range of solutions for complex primary and revision knee arthroplasty. These new implant technologies are designed to provide an efficient and seamless transition from standard primary to revision knee procedures, with a minimal number of additional instruments and trays. The EMPOWR Universal Tibial baseplate maintains the EMPOWR System’s characteristic asymmetric footprint which maximizes cortical coverage and prevents component overhang to ensure long-term fixation without tissue irritation4. This baseplate also provides the ability to stem and augment when more supplementary fixation is required. The VVC insert is offered in e+ polyethene, formulated to reduce long-term wear3, while the insert is designed to provide the necessary support and stability in knees with supportive soft tissue deficiencies.

“DJO has a proven record of bringing high-quality products to market with incredible cadence—faster than any other implant company today,” said Dr. Eugene S. Krauss, an orthopedic surgeon with Northwell Health. “In 2018 alone, the EMPOWR Porous Knee and EMPOWR Complex Primary Knee launches have significantly expanded our ability to treat a wide variety of patients in our practices.”

“The efficiency of DJO’s instrument trays and the streamlined instrumentation enables my surgical team and I to perform up to 12 knee replacements in a single day, making the system well-suited for both hospital and ambulatory surgery center environments,” said Dr. Krauss.

Over the past decade, the science of highly porous metals, including DJO’s P2, has significantly advanced, helping to improve implant longevity and ultimately patient outcomes. These scientific advancements coupled with a younger, healthier patient population, have resulted in a resurgence of cementless knee arthroplasty. Therefore, the contemporary design of the EMPOWR Porous Knee, is certain to have a meaningful impact on the market.

“DJO Surgical’s strong growth over the past few years is a reflection of our commitment to developing products and solutions that help improve clinical outcomes and enhance patient experience,” said Jeffery A. McCaulley, Global President of DJO Surgical. “Our continued expansion of the EMPOWR Platform reflects the overwhelmingly positive reaction we’ve received from surgeons and patients since the first EMPOWR Knee System was launched here at AAHKS in 2015.”

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Robotic Arm Offers Self-Help Mobile Rehab For Stroke Patients 

Robotic Arm Offers Self-Help Mobile Rehab For Stroke Patients  | IT Support and Hardware for Clinics | Scoop.it

The Hong Kong Polytechnic University (PolyU) recently developed a robotic arm to facilitate self-help and upper-limb mobile rehabilitation for stroke patients. The lightweight device enables the patients to engage in intensive and effective self-help rehabilitation exercise anywhere, anytime after they are discharged from the hospital. The robotic arm, called “mobile exo-neuro-musculo-skeleton,” is the first-of-its-kind integration of exoskeleton, soft robot, and exo-nerve stimulation technologies.

Stroke is the third leading cause of disability worldwide1. In Hong Kong, there are about 25,000 new incidences of stroke annually in recent years2. Research studies have proven that intensive, repeated and long-term rehabilitation training are critical for enhancing the physical mobility of stroke patients, thus helping to alleviate post-stroke symptoms such as disability. However, access to the outpatient rehabilitation service for stroke patients has been difficult. Due to the overwhelming demand for rehabilitation services, patients have to queue up for a long time to get a slot for rehabilitation training. As such, they can’t get timely support and routine rehabilitation exercises. Stroke patients also find it challenging to travel from home to outpatient clinics.

The “mobile exo-neuro-musculo-skeleton,” developed by Dr. Hu Xiao-ling and her research team in the Department of Biomedical Engineering (BME) of PolyU, features lightweight design (up to 300g for wearable upper limb components, which are fit for different functional training needs), low power demand (12V rechargeable battery supply for 4-hour continuous use), and sportswear features. The robotic arm thus provides a flexible, self-help, easy-to-use, mobile tool for patients to supplement their rehabilitation sessions at the clinic. The innovative training option can effectively enhance the rehabilitation progress.

 

Dr. Hu Xiaoling said development of the novel device was inspired by the feedback of many stroke patients who were discharged from the hospital. They faced problems in having regular and intensive rehabilitation training crucial for limb recovery. “We are confident that with our mobile exo-neuro-musculo-skeleton, stroke patients can conduct rehabilitation training anytime and anywhere, turning the training into part of their daily activities. We hope such flexible self-help training can well supplement traditional outpatient rehabilitation services, helping stroke patients achieve a much better rehabilitation progress.” Her team anticipated that the robotic arm could be commercialized in two years.

The BME innovation integrates exoskeleton and soft robot structural designs—the two technologies commonly adopted in existing upper-limb rehabilitation training devices for stroke patients as well as the PolyU-patented exo-nerve stimulation technology.

Integration of Exoskeleton, Soft Robot, and Exo-Nerve Stimulation Technologies
The working principle of both exoskeleton and soft robot designs is to provide external mechanical forces driven by voluntary muscle signals to assist the patient’s desired joint movement. Conventional exoskeleton structure is mainly constructed by orthotic materials such as metal and plastic, simulating external bones of the patient. Although it is compact, it is heavy and uncomfortable to wear. The soft robot, made of air-filled or liquid-filled pipes to simulate one’s external muscles, is light in weight but very bulky in size. Both types of structures demand high electrical power for driving motors or pumps, thus it is not convenient for patients to use them outside hospitals or rehabilitation centers. Combining the advantages of both structural designs, the BME innovative robotic arm is light in weight, compact in size, fast in response and demands minimal power supply, therefore it is suitable for use in both indoor and outdoor environment.

 

The robotic arm is unique in performing outstanding rehabilitation effect by further integrating the external mechanical force design with the PolyU-patented Neuro-muscular Electrical Stimulation (NMES) technology. Upon detecting the electromyography signals at the user’s muscles, the device will respond by applying NMES to contract the muscles, as well as exerting external mechanical forces to assist the joint’s desired voluntary movement. Research studies found that the combination of muscle strength triggered by NMES and external mechanical forces is 40 percent more effective for stroke rehabilitation than applying external mechanical forces alone.

Rehabilitation Effect Proven in Trials
An initial trial of the robotic arm on 10 stroke patients indicated better muscle coordination, wrist and finger functions, and lower muscle spasticity of all after they have completed 20 two-hour training sessions. Further clinical trials will be carried out in collaboration with hospitals and clinics.

The robotic arm consists of components for wrist/hand, elbow, and fingers which can be worn separately or together for different functional training needs. The sportswear design, using washable fabric with ultraviolet protection and good ventilation, also makes the robotic arm a comfortable wear for the patients.

The device also has a value-added feature of connecting to a mobile application (APP) where users can use the APP interface to control their own training. The APP also records real-time training data for better monitoring of the rehabilitation progress by both healthcare practitioners and the patients themselves. It can also serve as a social network platform for stroke patients to communicate online with each other for mutual support.

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Health Care Providers Face More Direct Billing, More and Tougher Collections

Health Care Providers Face More Direct Billing, More and Tougher Collections | IT Support and Hardware for Clinics | Scoop.it

Opponents figure that they pretty much killed the Affordable Care Act in December when they ended the individual mandate. They may be right. The mandate – the part of the ACA that required Americans to buy health insurance or face a minor penalty – was a key to trying to broaden and deepen the insurance pool, mitigate payers’ risk and, not least, keep premiums at least remotely tethered to people’s ability to pay.

 

Another part of the ACA is also under threat. The law allowed states to agree to an expansion of Medicaid that was meant to help people who couldn’t afford to meet the mandate on their own.  Still another: it also offered subsidies to help payers meet the expenses of covering all the previously untreated people they’d have to insure and of covering everyone’s pre-existing conditions. 

Premiums in fact did not grow as fast in states that accepted the Medicaid expansion during the past three years and as an estimated 40 million more people gained some form of health insurance.

The end of the individual mandate, the junking of one of the subsidies for health insurers and last year’s drastically truncated open enrollment period for the remaining Exchange plans, however, have again started to reduce the number of Americans with health insurance.

 

These changes affect more than practice volume. They impact operations for practices that retain patients, too.

For without increased attention to “revenue cycle,” all health care providers can expect to be doing more direct billing of patients, doing more collections work and assuming more bad debt from people with higher, tougher-to-pay deductibles in the coming months and years.

 

Here’s why: No one yet knows how many people who bought insurance only because they were required to. There’s reason to believe the end of the individual mandate will start making them drop out of all kinds of plans during the next open enrollment period.

A federally truncated open enrollment period October-December, 2017 has already reduced the number of insured people in the nation.  A number of forces are leading fewer people – and fewer younger, healthy people – to buy plans, and some predictions have premiums rising an extra 10 percent this coming year.

 

More shrinkage is coming. Newly permitted work requirements for Medicaid coverage promise to push still more people into the ranks of the uninsured. Kentucky’s new rules, for example, will drive an estimated 40,000 people out of Medicaid coverage during the next five years. As of this writing, nine other states are considering imposing new restrictions on who can qualify for Medicaid coverage.

 

The increase in the numbers of the uninsured obviously has disturbing implications for the nation’s health as a whole. It will also force payers to raise premiums to make up for the rising costs of being able to spread their risk across smaller, riskier customer pools.

 

The uninsured aren’t the only ones threatening practice finances.

Rising premiums, in turn, are leading employers to offer employees more high-deductible health plans. These HDHPs have lower premiums but higher risk for patients, who in addition to their premiums must pay an average of the first $2,400 of their families’ medical bills out of their own pockets. Some plans have deductibles as high as $10,000.

 

The lower premium costs, however, are attracting more and more people.

 

They are also higher risks for physician practices, which have a harder time collecting from patients with HDHPs. Thirty-seven percent of the people working for employers who offered plans in 2017 chose high-deductible plans. That’s up from 28 percent in 2016. The same year, that accounted for 39.3 percent of all Americans on employer-based health plans. All told, up to 37 percent of insured Americans, regardless of where they bought it, were using HDHPs.

 

But there have been dire unintended consequences. With the costs of care so high, 64 percent of those with high-deductible plans say they’ve put off care because they didn’t want to or couldn’t pay the deductible. And 62 percent said that, despite the lower premiums, they end up spending more on health care than under their previous plan.

 

People with the high-deductible plans thus tend to be bigger financial risks for providers.

Of HDHP customers, 15.5 percent reported having trouble paying medical bills in 2016 (versus 10.3 percent of those with “traditional” plans).

 

In sum, this means everyone in health care – providers, hospitals, practices – are going to chance offending more patients by billing them directly and, at minimum, going to have to devote more resources to revenue cycle and collecting what patients owe them.

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4 Advantages of Maintenance Support

4 Advantages of Maintenance Support | IT Support and Hardware for Clinics | Scoop.it

Managing your hardware and software maintenance contracts can be overwhelming. Most IT assets are under contract and need ongoing support, and with every contract comes a tremendous amount of administrative work to keep those assets covered. As your assets grow in numbers, so does the total across your entire IT infrastructure, making it difficult to track properly.

 

Whether you are managing the contracts on your own, overseeing asset turnover, handling aging assets, or monitoring service levels compliance, it requires continuous effort. This is true for both hardware and software components. As more and more products move from hardware-based to software-based, it creates even more tracking challenges simply because there is no longer a physical asset. Tracking all of these assets with so many moving pieces and multiple manufacturers—from individual asset stop dates to maintenance coverage—can get confusing, convoluted, and leaves a margin for error.

 

Mistakes made could lead to a lapse in contract coverage, costing more money to renew in the long run. When you work with a maintenance support services partner, your assets are effectively managed so you can use them to drive more business.

 

Four Benefits of Having Your Maintenance Handled for You

 

1. Better analysis

With many individual assets to manage, it can be difficult to find the time to identify what needs to be done to remain compliant and run most effectively. With maintenance support, you no longer have to worry whether the information looks right or wrong. Instead, you will receive a thorough analysis of all of your information so you can make the best decisions for your business based on that analysis.

 

2. Cost savings

Not only does a proper analysis provide more accurate data management, it is also a friend to your bottom line. Ongoing asset analysis tackles the complexity of maintenance contracts, including multiple manufacturers, so you can prioritize what’s most important for your business. Not only is someone monitoring your assets for you, but they are also determining if the information is up to date and, in turn, identifying areas that can be reallocated, ultimately cutting costs.

 

3. Time savings

With cost savings, comes time savings. You can remove hours of time from your day, while getting a clearer depiction of your assets. When a maintenance support services partner is tasked with analyzing your assets, you’ll receive more efficient reporting, allowing you to make better and faster decisions for your business.

 

4. Lifecycle management

Get the help you need with lifecycle management and streamline your current support to be as efficient as possible based on your specific assets. With a coverage methodology, you can rest easy knowing that your assets and devices are subject to a thorough analysis, which ensures that everything is functioning optimally. By understanding your inventory and how everything is working together (including aging devices) you will be positioned well for future budgeting and remove any roadblocks if there are specific support issues.

 

Get the Support You Need to Focus on Business Priorities

Having the support you need can help you focus on your business, instead of dealing with the logistics and tracking associated with complicated maintenance contracts. Take advantage of better, more efficient analysis so you can make more informed decisions about your hardware and software devices, save on time and costs, and improve your lifecycle management capabilities.

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Tech Talks: 8×8 Delivers Secure Cloud Communication Solutions

Tech Talks: 8×8 Delivers Secure Cloud Communication Solutions | IT Support and Hardware for Clinics | Scoop.it

Would you like to enhance your customer experience (CX) with reliable and secure cloud-based solutions? If so, you might want to consider 8×8, a leading provider of communication-related products for businesses of all sizes looking to enhance their customer experience and increase staff engagement.

 

Our consultants recently attended a presentation and “sales blitz” by this cloud solution provider and got a detailed look at their key offerings. Here’s some of what we know about 8×8 that we’d like to share with you if you’re a business leader looking to improve your communication capabilities. Provider Overview Founded in 1987 and based in San Jose, Calif., 8×8 focuses on delivering cloud solutions that help companies transform both their team members’ and customers’ experiences.

 

This vendor’s solutions give businesses the ability to communicate and collaborate effectively and quickly with a single system of engagement for contact center, voice, video, and collaboration. 8×8 has earned recognition as a leading cloud-based communication solutions provider: For instance, the vendor has been named a leader in the Gartner Magic Quadrant for Unified Communications as a Service, Worldwide for seven years in a row. Unique Differentiator 8×8 has its own platform and native cloud contact center, rather than running on BroadSoft or another third-party cloud contact center like many of its competitors.

 

This gives them a considerable edge, as their clients realize the benefits of an all-in-one platform and provider. Featured Offerings 8×8 provides a wide range of communication solutions, such as VoIP business phone service, web conferencing, hosted PBX, virtual contact center, UC and more. Here are just a couple of their notable offerings. Business Phone Systems: An X Series Business Phone System solution from 8×8 gives you a single cloud platform for meetings, voice, call center, collaboration and more. Select elements of the different plans (starting with X2) to meet your company’s specific needs. This solution is available for small businesses as well as larger enterprises.

 

Cloud Contact Center: Enhance your customer experience with a cost-effective X Series Cloud Contact Center. Choose the model that best fits your communication needs, from the X5 (voice contact center with predictive dialer) up to the X8 (multi-channel contact center with predictive dialer and advanced analytics). Security and Compliance Guaranteed Additionally, for clients that must comply with industry regulations, this vendor’s Virtual Office and Virtual Contact Center solutions are certified as compliant with the following standards: HIPAA FISMA CPNI ISO 27001 ISO 9001 UK Government ATO Privacy Shield Framework Cyber Essentials

 

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3 Common Technology Problems and How to Solve Them

3 Common Technology Problems and How to Solve Them | IT Support and Hardware for Clinics | Scoop.it

We know that businesses struggle to keep their IT in optimal working condition. While some problems take the skilled hand of an expert to fix properly, many other issues are easier to deal with internally, but still, go chronically unaddressed. Here are some of those problems, and tips for how to deal with them.

Problem 1 – Inconsistent or Lackluster Email Security

Did you know that 92.4% of all malware is delivered via email? That’s from Verizon’s 2018 Data Breach Investigations Report. Not only is email an effective means for hackers to send you malware, but it’s a successful one too. The same Verizon report found that people in the U.S open 30% of all phishing emails, with 12% of people even clicking on the link inside the email.

 

These statistics point to a two-sided problem. Hackers know that email is a great way to get into your company, and employees are still not being cautious enough about their email usage. So, what’s the best way to help secure your email system against compromise?

 

  • Enable Two-Factor Authentication (2FA)
    This is the easiest measure to take. Two-factor authentication provides an extra layer of security that goes beyond just simple username and passwords. It requires that users verify their identity with a code sent to an authorized device (usually a cell phone), which can go a long way to keeping unauthorized users out of business email accounts. Unfortunately, 2FA adoption remains stubbornly low at businesses, despite the greatly increased security that it provides. One of the reasons holding 2FA back is that there are several different versions available, including SMS/mobile based solutions, physical keys, app-based models, and others.

 

There are advantages and disadvantages to each of these methods, so pick a 2FA model that meets the specific security and compliance needs of your organization.

 

  • Teach Employees Email Best Practices
    According to recent data from Wombat Security, 30% of employees in the U.S. don’t even know what phishing is. That’s a big problem, as your team is the first line of defense against email-delivered cyber threats.

 

Teach your employees how to defend themselves. Go over the basics, such as poor grammar, incorrect spelling, suspicious email addresses, and other phishing red flags. Company policies against bad habits, like leaving email accounts open when you’re away from your desks, can also be very helpful. You may even want to give your staff the occasional quiz to ensure that they’re aware of the most important threats, and to educate them in a fun and memorable way.

 

Have you implemented email encryption or malware scanning for your email attachments yet? If not, those are two technical measures you can take to improve email security quickly. You may also want to think about enforcing an email retention policy. Regularly deleting emails is a best practice that’s often a vital part of maintaining regulatory compliance.

Problem 2 – Poor IT Vendor Management

According to this survey from the Tech Republic, 57% of companies say that they’re spending more time managing their IT vendors than just two years ago, driven by the growing interest in cloud computing, SaaS, and cybersecurity services. IT vendor management is crucial to helping you deliver positive IT outcomes and control the cost of these services.

 

Engage company stakeholders and subject matter experts to form a workgroup to manage your vendors. While each vendor management process will differ, you’ll want to centralize all the related information, including contracts and related documents into one data repository. This body of information will help you evaluate your IT vendors to ensure they’re still a good fit for your needs, as well as negotiate future contracts.

 

From a cybersecurity point of view, you’ll also want to create a security risk profile for each vendor. As the number of vendors your company uses grows, so does the difficulty of maintaining strong security. According to PwC, 74% of companies do not have a complete inventory of the third parties that handle personal employee or customer data, a glaring oversight that your vendor management team should seek to rectify.

 

Proper IT vendor management is critical to any compliance efforts, meaning that this work must be handled with great care in regulated industries like finance and healthcare. In these cases, you’ll likely need the help of a trusted technology partner.

Problem 3 — Poorly Secured Workstations

Cybersecurity is a big, very important topic, which we’ve written a white paper on. One area of security where we’ve noticed many businesses fall short is in securing their workstations.

 

On any given day, a workstation may get used by several different employees or teams. Because they often hold valuable data that’s directly related to your productivity, these computers must be held to a higher standard of security than your average PC or mobile device.

 

  • Employ Stronger Passwords
    81% of hacking-related data breaches involve a compromised Because passwords are all that separate your workstation data from a malicious outsider (or insider), you’ll want to make sure that all your passwords adhere to the current best practices — which are constantly evolving. Did you know, for example, that mixing upper-case and lower-case letters are no longer seen as the best way to create a strong password? In fact, the man who came up with that idea in the first place now regrets ever saying it. Instead, combine 3 or 4 unrelated English words and sprinkle a number or two in for good measure. This provides a much stronger foundation for a secure workstation.

 

  • Secure Administrator Accounts and Privileges
    Administrator accounts have the ability to move data around your computer network in ways that standard user accounts can’t. This makes them attractive to interlopers, who will do whatever they can do to gain administrator access, like social engineering. Start by making sure that all default passwords have been changed and are different on each of your workstations. Using the same passwords on any two workstations could cause problems, by encouraging a successful hacker to move laterally through your network. While you’re at it, make sure that your admins aren’t using their administrator accounts for their daily work. This is another easy fix, but we see it all the time. Having your administrators use a separate account for non-administrative duties will help ensure that if their regular account gets compromised, the account with the privileged access remains secure.
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Make sure your VoIP phones survive a disaster

Make sure your VoIP phones survive a disaster | IT Support and Hardware for Clinics | Scoop.it

Voice over Internet Protocol (VoIP) telephony systems are great for today’s businesses. They’re more mobile with greater functionality and better cost efficiency versus traditional landline phones. But as with any technology, VoIP is vulnerable to disruptions due to equipment failure, disasters, and cyberattacks. Plan ahead and make sure your VoIP can weather any breakdown.

Invest in VoIP monitoring services

Before implementing any disaster recovery solutions, install a third-party VoIP monitoring service to keep tabs on the status of your phone system. This will identify all network issues disrupting your phone system, so you can resolve them quickly.

Choose your VoIP provider wisely

When evaluating VoIP systems, you must verify your provider’s service-level agreements. Ask them about their security and availability guarantees, and how they’re able to achieve them.

Whomever you partner with, be sure they host your VoIP systems in facilities that are safe from local disasters. Your provider should also use advanced network security services to protect your calls.

Have a backup broadband line

Because VoIP solutions are dependent on internet connections, you should have a backup or alternate internet service in case one network goes down.

Ideally, one internet service provider (ISP) will be dedicated to your VoIP service, while another supports your main computer network. Once you’ve installed both networks, you can then program them to automatically transfer services to the other should one network fail. Thus, if your main phone network goes down, your VoIP solution switches to the other network so you can keep working.

Of course, subscribing to two separate ISPs will increase your internet expenses, but the cost to maintain both is far less than the cost of significant downtime.

Route calls to mobile devices

With a cloud-based VoIP solution, you can choose where to receive your calls with call forwarding — a feature that automatically reroutes incoming calls to other company-registered devices. If your main office is hit by a local disaster or network outage, your employees can continue working from their mobile devices as if nothing happened.

To benefit from this feature, make sure to register all employee mobile devices to your VoIP system and configure such devices to receive rerouted calls.

And don’t forget to set policies for remote working. You should have rules that forbid staff from connecting to public WiFi networks, as this can put them at risk of VoIP eavesdropping.

Test your plan

There’s little value in a VoIP continuity plan if it isn’t tested on a regular basis. Test your VoIP service and check whether contact details are up to date, call forwarding features are routing calls to the right devices, and your backup internet service works. Ultimately, your goal is to find flaws in your VoIP recovery strategy and make necessary adjustments to avoid them from occurring in the future.

 

If managing VoIP is too time-consuming and complex, call our professionals today. We design, implement, and test a powerful, disaster-proof VoIP phone system to ensure your communications are always online.

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3 Common Technology Problems and How to Solve Them

3 Common Technology Problems and How to Solve Them | IT Support and Hardware for Clinics | Scoop.it

We know that businesses struggle to keep their IT in optimal working condition. While some problems take the skilled hand of an expert to fix properly, many other issues are easier to deal with internally, but still, go chronically unaddressed. Here are some of those problems, and tips for how to deal with them.

 

Problem 1 – Inconsistent or Lackluster Email Security

Did you know that 92.4% of all malware is delivered via email? That’s from Verizon’s 2018 Data Breach Investigations Report. Not only is email an effective means for hackers to send you malware, but it’s a successful one too. The same Verizon report found that people in the U.S open 30% of all phishing emails, with 12% of people even clicking on the link inside the email.

 

These statistics point to a two-sided problem. Hackers know that email is a great way to get into your company, and employees are still not being cautious enough about their email usage. So, what’s the best way to help secure your email system against compromise?

  • Enable Two-Factor Authentication (2FA)
    This is the easiest measure to take. Two-factor authentication provides an extra layer of security that goes beyond just simple username and passwords. It requires that users verify their identity with a code sent to an authorized device (usually a cell phone), which can go a long way to keeping unauthorized users out of business email accounts.Unfortunately, 2FA adoption remains stubbornly low at businesses, despite the greatly increased security that it provides. One of the reasons holding 2FA back is that there are several different versions available, including SMS/mobile based solutions, physical keys, app-based models, and others. There are advantages and disadvantages to each of these methods, so pick a 2FA model that meets the specific security and compliance needs of your organization.
  • Teach Employees Email Best Practices
    According to recent data from Wombat Security, 30% of employees in the U.S. don’t even know what phishing is. That’s a big problem, as your team is the first line of defense against email-delivered cyber threats.

Teach your employees how to defend themselves. Go over the basics, such as poor grammar, incorrect spelling, suspicious email addresses, and other phishing red flags. Company policies against bad habits, like leaving email accounts open when you’re away from your desks, can also be very helpful. You may even want to give your staff the occasional quiz to ensure that they’re aware of the most important threats, and to educate them in a fun and memorable way.

 

Have you implemented email encryption or malware scanning for your email attachments yet? If not, those are two technical measures you can take to improve email security quickly. You may also want to think about enforcing an email retention policy. Regularly deleting emails is a best practice that’s often a vital part of maintaining regulatory compliance.

Problem 2 – Poor IT Vendor Management

According to this survey from the Tech Republic, 57% of companies say that they’re spending more time managing their IT vendors than just two years ago, driven by growing interest in cloud computing, SaaS, and cybersecurity services. IT vendor management is crucial to helping you deliver positive IT outcomes and control the cost of these services.

 

Engage company stakeholders and subject matter experts to form a workgroup to manage your vendors. While each vendor management process will differ, you’ll want to centralize all the related information, including contracts and related documents into one data repository. This body of information will help you evaluate your IT vendors to ensure they’re still a good fit for your needs, as well as negotiate future contracts.

 

From a cybersecurity point of view, you’ll also want to create a security risk profile for each vendor. As the number of vendors your company uses grows, so does the difficulty of maintaining strong security. According to PwC, 74% of companies do not have a complete inventory of the third parties that handle personal employee or customer data, a glaring oversight that your vendor management team should seek to rectify.

Proper IT vendor management is critical to any compliance efforts, meaning that this work must be handled with great care in regulated industries like finance and healthcare. In these cases, you’ll likely need the help of a trusted technology partner.

Problem 3 — Poorly Secured Workstations

Cybersecurity is a big, very important topic, which we’ve written a white paper on. One area of security where we’ve noticed many businesses fall short is in securing their workstations.

On any given day, a workstation may get used by several different employees or teams. Because they often hold valuable data that’s directly related to your productivity, these computers must be held to a higher standard of security than your average PC or mobile device.

  • Employ Stronger Passwords
    81% of hacking-related data breaches involve a compromisedBecause passwords are all that separate your workstation data from a malicious outsider (or insider), you’ll want to make sure that all your passwords adhere to the current best practices — which are constantly evolving.Did you know, for example, that mixing upper-case and lower-case letters are no longer seen as the best way to create a strong password? In fact, the man who came up with that idea in the first place now regrets ever saying it. Instead, combine 3 or 4 unrelated English words and sprinkle a number or two in for good measure. This provides a much stronger foundation for a secure workstation.
  • Secure Administrator Accounts and Privileges
    Administrator accounts have the ability to move data around your computer network in ways that standard user accounts can’t. This makes them attractive to interlopers, who will do whatever they can do to gain administrator access, like social engineering.Start by making sure that all default passwords have been changed and are different on each of your workstations. Using the same passwords on any two workstations could cause problems, by encouraging a successful hacker to move laterally through your network.While you’re at it, make sure that your admins aren’t using their administrator accounts for their daily work. This is another easy fix, but we see it all the time. Having your administrators use a separate account for non-administrative duties will help ensure that if their regular account gets compromised, the account with the privileged access remains secure.

 

 

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Servers In Medical Centres

Servers In Medical Centres | IT Support and Hardware for Clinics | Scoop.it

Servers in medical centres are a common aspect if IT support & maintenance. Here’s a tip for Healthcare IT Support.

 

Some use a PC which is configured to act as a server, other healthcare organisations would have implemented a professional business grade server to store their medical applications and finally, some use cloud based server which are essentially virtual servers.

 

At some stage in the business’s lifecycle, the network or IT environment begins to slow down, become slightly unreliable and you hear more and more frustrations from the staff.

 

The typical knee jerk reaction will always be to reinvest into a new server and replace the old one. This can be an expensive, complex and frustrating exercise if its not completed by a dedicated healthcare IT professional.

 

In this blog we wanted to share something a little different; some strategies which will make your network more reliable, increase the lifecycle of your server and finally, help you save your money.

 

Our hot tips are:

 

Monthly Server Maintenance
By far the easiest and most important task. The monthly server maintenance can be implemented by your IT provider (or if you are interested, email us and we will give you the steps on how to do it).

The monthly maintenance includes installing all the new server operating system updates, the clinical software updates, updating your antivirus and third party software.

Other tasks include checking your disk space and removing any temporary files, rebooting the server and finally, deleting any unnecessary files in the downloads or documents folder.

This activity will ensure that your server is up to date and the reboot will run all the required servers correctly.

 

Upgrade Your Firmware Every 6 Months
We highly recommend you engage an IT professional for this activity. According to the world’s leading technology vendors, over 90% of hardware reliability issues are due to the lack of updating the machine’s firmware.

 

Firmware is a software product which managed the hardware of your server and it effects the way it behaves. By upgrading the firmware of your server, you are installing the latest updates, fixes and patches which directly relate to your server.

 

Some benefits of firmware updates include a faster server, less over heating, less server lockups and most importantly, a longer lifecycle.

 

Add More RAM & Hard Disk Space
When you purchased your server it would’ve had little load on it. Your staff numbers were limited and back then it didn’t have to support new updates.

 

As your clinic grows and the network requirements become more, your server will begin to feel the load. Its memory is now at full capacity and its working as hard as possible.

 

By upgrading the RAM and hard disk space (if you are not sure how to do it, contact your IT provider OR US), you are essentially giving your server more resources to handle the extra load.

 

This upgrade usually costs about 15% the price of a new server and in turn, saving you more money and giving your network more firepower.

 

Manage Your Backups Correctly
Running a backup is one of the most memory heavy tasks a server can do. A backup can take up all the memory and CPU power. Our strategy is to always ensure that the backup of your server and clinical data is running outside business hours. This way you won’t feel the network on the server.

 

Implement The Right Configurations
A very open term I know however configuring the server in the right way does play a big part on how it behaves when processing data and ensuring that your clinic staff can access their medical applications.

 

A simple example would be implementing an Active Directory role (technical I know however this is important). If your server is setup as an active directory then it can manage and facilitate how the users access the data in a more efficient way.

 

Another recommendation would be to setup your server as DHCP and DNS. This way when you access your clinical applications (Medical Director, Genie, Best Practice etc..) then the network computers can quickly find the server and locate the clinical database.

 

Check The Firewall Settings
Most of the connection issues (speed, reliability) relate to 3 core aspects, the quality of the connection between the computer and the server, the way the server is configured and finally, the way the firewall is configured.

 

Depending on which firewall solution you have in place, it needs to be configured correctly so that it allows undisturbed access to the clinical applications from the clinic’s computer.

 

If the firewall is not configured correctly then you will notice that the network will be slow, so will the server and finally, so will the clinical applications.

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Medical Device Quality: Why Software Is More Challenging Than Hardware

Medical Device Quality: Why Software Is More Challenging Than Hardware | IT Support and Hardware for Clinics | Scoop.it

The U.S. Food and Drug Administration’s (FDA) Quality System Regulation 21 CFR Part 820.30(g) states, “Design validation shall include software validation and risk analysis, where appropriate.” The words, “where appropriate,” indicate that further guidance is necessary to successfully comply with the regulation. FDA’s guidance document, “General Principles of Software Validation,” is an important first read in that regard, but many medical device manufacturers are not sufficiently familiar with it.

 

It is impossible to imagine the medical device industry today without the software revolution. From defibrillators to infusion pumps and robotic surgical systems, a broad range of devices relies on software to function safely and effectively. At the same time, medical device software has introduced a level of complexity that dwarfs anything seen before in the field. This column addresses some basic facts about medical device software and how quality professionals, together with executive management, can work together to ensure that FDA’s rigorous requirements are satisfied.

 

Note that FDA has separate requirements for medical device software and quality system software. This column addresses only the software that is part of a medical device, such as software that triggers an alarm when a product fails. Other software, such as that used by a medical device manufacturer to manage complaints in its quality system, is outside of the scope of this discussion.

 

In October 2017, FDA released two new final guidance documents on the same day: “Deciding When to Submit a 510(k) for a Change to an Existing Device” and “Deciding When to Submit a 510(k) for a Software Change to an Existing Device.” In other words, medical device software changes have so many unique challenges and risks that they earn a guidance document of their own, separate from all other device changes.


The Problem: Software Is Different from Hardware
Validation is at the heart of device design, and the validation of software design is especially challenging. Even though FDA’s guidance document, “General Principles of Software Validation,” was last updated in January 2002, that guidance is still highly relevant and useful. When a medical device incorporates software, FDA expects the manufacturer to be well-read in the guidance document.

 

Furthermore, FDA does not intend the guidance document on software validation to be read only by software developers or quality engineers, as it states, “Software engineering needs an even greater level of managerial scrutiny and control than hardware engineering.” The guidance is written in laymen’s terms, so executive management is not excused from this responsibility, even when they have limited experience in software development.

To get to the heart of the problem, the guidance document on software validation includes the deceptively simple statement: “Software is different from hardware.” Actually, there are many complex differences between software and hardware, and understanding those differences is key to ensuring that software validation will pass FDA muster. The comparison chart (above and on the previous page) is adapted from, and expands on, the FDA guidance.

 

The Solution: Software Validation Driven by Rigorous Requirements


Both of the last two differences in the chart use the phrase, “a clear set of detailed requirements.” This is the most crucial element for proper software validation, and one that is frequently neglected. The flow chart figure on page 20 illustrates how requirements play an early and crucial role in software development.

 

During the phases that developers are coding and testing the software, the requirements enter a tunnel that is closed to non-developers, and the software emerges from the other side as a complete design. The resulting software can support a safe and effective device only if executive management and other stakeholders have reviewed a detailed and unambiguous set of requirements. Quality and regulatory teams can expedite this crucial phase by ensuring smooth communications between engineering and the rest of the organization.

 

At the far end of the tunnel, quality and regulatory conduct the final stages of user site testing with faithful attention to the original requirements. As noted in the list of differences between software and hardware, “user expectations are often unexpected,” and any expectations that were not properly specified as requirements are likely to emerge as errors during testing.

 

Clearly, the future of medical device development is bound up with new advances in software—wearable devices, remote medicine, algorithmic diagnostics, and robotics. FDA expects that manufacturers’ quality systems and design controls will ensure safety and efficacy, even as the software code at the heart of the device remains opaque to executive management. Software design might be more challenging than hardware, but software validation will keep the differences manageable and the quality undiminished.

 

Dan Goldstein is a manager for Quality Assurance at Musculoskeletal Clinical Regulatory Advisors (MCRA), primarily focusing on quality system requirements for bringing new devices to market and keeping experienced manufacturers in compliance with FDA and Notified Bodies. He provides MCRA clients with gap assessments, mock FDA inspections, Form 483 remediations, Design History Files, Technical Files, Summary Technical Documents, and Clinical Evaluation Reports. A graduate of the University of Maryland University College, Dan has worked since 2002 in quality assurance for medical devices, including autologous blood products for wound healing and computer-aided-detection software for lung diseases. Musculoskeletal Clinical Regulatory Advisers LLC has broad experience in the area of software validation. MCRA’s staff is especially adept at promoting and maintaining the lines of communication that keep executive management, the “voice of the customer,” and software developers on the same page with regard to the detailed requirements that drive the development process. The organization believes in requirements that follow the “four Cs”—clear, concise, correct, and complete.

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EHR Hardware Basics in Health IT Guides

EHR Hardware Basics in Health IT Guides | IT Support and Hardware for Clinics | Scoop.it

Hardware Basics for Electronic Health Records

 

Basic Terms


Workstation - This refers to the hardware that holds everything a physician or office staff worker needs to perform their jobs: word processing, practice management software, EHR software, fax software, etc.


Desktop - One of three basic types of workstations. This describes a fixed, hard-wired computer that does not move around. The computer can actually sit on the top of the desk (desktop) or on the floor (tower).


Laptop - One of three basic types of workstations. This is a portable computer that has a keyboard and either a touchpad, stick, or mouse for moving the cursor around the screen. It is a fully functioning computer that can be carried or placed on a cart and moved around the office.


Tablet PC - One of three basic types of workstations. Tablet PCs contain built-in handwriting recognitions software that allows the user to "write" on the screen using a stylus, much as they would write on paper attached to a clipboard. Tablet PCs can have add-on keyboards for instances when typing is preferred.


Desktops


The basics:

 

  • A desktop computer usually has a standard configuration consisting of a CPU, monitor, keyboard, and mouse.
  • It is stationary; it resides in one location and cannot be moved from room to room.
  • It can stand alone or work with any of a variety of network arrangements

 

Advantages:

  • Desktops are low-cost and available from a wide variety of vendors.
  • Because desktop PCs are standardized, it is relatively easy and inexpensive to find spare parts and support, or to replace a machine.
  • Desktops will run just about any software you need.
  • Additional devices such as microphones, speakers, and headsets are readily available at low cost.

 

Disadvantages:

  • Because it's stationary, you need to buy a desktop PC for each room in which you need access to your EHR software.
  • Desktops typically take up more space than a laptop or tablet PC. While flat screen monitors and tower units save actual desktop space, the standard desktop computer requires more room than either a laptop or tablet PC.
  • You must purchase additional equipment to take full advantage of voice recognition and/or handwriting recognition programs.

 

What your peers have to say:
"Have had wired computers [desktops] in the exam room since 1998 and think it is the best way. I find it less hassle than carrying a computer around all day, worrying about batteries running out or losing wireless connectivity or dropping the computers. The computers are much cheaper both to buy initially and fix if something does happen. Tried a tablet but did not like it all. Never had a problem with children or adults interfering with the computer in the examining room and if you log out when you leave, HIPAA is not an issue."
-- Keith Stafford, MD, Greenville, South Carolina


Laptops


The basics:


A laptop is a fully functioning computer that is small enough to be portable. Laptops can take advantage of wireless as well as traditional networks. A laptop can easily serve as a desktop machine and can connect via a docking station to a larger monitor and a standard keyboard.

 

Advantages:

  • A laptop has a smaller footprint and can easily be turned to allow patients to view information on the screen.
  • A laptop is less obtrusive during patient interviews.
    Most have fairly long battery life and/or an A/C adaptor.
    Laptops use standard PC inputs such as keyboard and mouse and/or touchpad.

 

Disadvantages:

  • Although laptops are portable, they can be heavy to carry, typically weighing five to eight pounds.
  • Repairs and maintenance tend to be more expensive because laptops use non-standard or proprietary parts. You may have to send a laptop off-site for diagnosis and repair.

 

What your peers have to say:
"

  • We work wirelessly with laptops. All [prescriptions] print from one central printer right outside the exam rooms. Benefits of laptop:
  • Can open the note and chart before entering the room and bring up appropriate templates. Can enter the room already knowing what HM is late and what the purpose of the visit is.
  • Can close the note right outside the room if you want to go ahead and have the patient leave before finishing a note.
    Can see with bifocals; no neck strain.
  • Can have all my personal settings and programs handy all the time - PDR, links, hospital links, etc.
  • Can look at patient easily over the top of the laptop and can easily show patients what I'm doing.
  • Touchpad is always in the same place in relation to keys; easy to switch from it to typing or tabbing without looking. I like having a full size keyboard.

 

"I'm hooked on my laptop and am so accustomed to carrying it around that I don't even notice even though it is Dell's heaviest one."
-- Sue Andrews, MD, Murfreesboro, Tennessee

 

Tablet PCs


The basics:
There are two main types of tablet PCs: a slate tablet PC, which is a tablet with no attached keyboard (although one can be added), and a convertible tablet PC, which is basically a laptop computer with a screen that can swivel and fold onto the keyboard to create the tablet.

 

Advantages:

  • Tablets are truly portable and lightweight, typically weighing three to four pounds.
  • It is as powerful as a PC, but it doesn't require a keyboard. Instead, you add information by writing on the screen with a digital pen or stylus, much like you do in a paper chart.
  • Handwriting recognition software developed for tablet PCs is excellent, even for very poor handwriting.
  • Tablet PCs have integrated dictation capability with voice recognition software that transcribes directly into the patient record.


Disadvantages:

  • Writing with a stylus takes getting used to; there is a longer learning curve in adapting to a new way of using a computer.
  • Handwriting recognition dictionaries have not yet fully integrated medical terminology and acronyms, requiring more correction.
  • There is not as much standardized software yet available for tablets.
  • Screens are easily scratched and can become unusable without screen protectors purchased at additional cost.

 

What your peers have to say:
"I have been using a Gateway tablet in the room with my OB patients for the past two years. We use an ASP prenatal record called eNatal. I wouldn't trade for it. It has three methods of entering data on the screen, all vastly improved with the SP2 for Windows XP for Tablet.

 

"The first method is through tapping on a screen-based keyboard with the stylus (slow but very accurate). The second is through straight handwriting recognition. I have relatively poor handwriting, but it is amazing how accurate and fast this is! The only thing that seems to trip it up is some abbreviations, acronyms, or words that it can not find in the dictionary. The third option is a letter-by-letter handwriting recognition panel that is slower but extremely accurate.

 

"We've had no downtime. The wireless connection works well. The battery life is good (I plug it into the docking cradle between OB patients). We have used laptops and desktops for eNatal in the rooms and the tablet works best by far. As we look to add a full EMR, we hope to use a tablet-based system, probably the Motion Computing tablets with the biometric (fingerprint) access."
-- G. Jeffrey Young, MD, FAAFP, Levelland, Texas


Using EHR technology require a certain adjustment in the way you're used to interacting with your patiens and their charts. Deciding how to do this in the way that makes you the most comfortable will help guide your choice of hardware -- e.g. using a desktop, laptop, or tablet PC.

 

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Tips To Help Ensure A Successful Surgeon Design Team

Tips To Help Ensure A Successful Surgeon Design Team | IT Support and Hardware for Clinics | Scoop.it

Design surgeons and surgeon design times have been at the core of the significant advances that have occurred in the medical device market in the last few decades. Working with surgeon design teams is inspirational, mentally demanding, and exciting.

 

Let’s assume a new opportunity has been identified that will improve your organization’s financial position. The marketing team has studied the market space—that is, classified at least three types of current and potentially new innovative strategies this opportunity should incorporate (as was described in the March/April 2018 issue of ODT, “Innovation and the Development Engineer”).

 

Once a complete financial plan, which includes cost to develop/introduce, and a sales/marketing plan have both been vetted and approved by the organization’s senior staff, it is time to move ahead to develop the surgeon design team.

 

I have had experience with two different types of surgeon design teams. The first—a “Hub and Spoke” model—was utilized in situations where aligning with a given group of surgeons or an institution would alienate others from using the product once it was released. The second is the more traditional surgeon design team with a group of surgeons selected to work on a project from beginning to end.

 

The Hub and Spoke model concept relies on one or two core key opinion leading (KOL) surgeons to serve as the hub of the wheel. Different surgeons or groups of surgeons meet independently with the KOL surgeon and the development engineering lead at a series of low-key meetings held at various time points to obtain feedback on different aspects of the design. There is a significant amount of reliance placed upon the KOL surgeon as the amount of involvement of the non-KOL surgeons is substantially less than in a traditional surgeon design team model. In this model, the non-KOL surgeons are assisting with validating the market assessments and need requirements, as well as providing market acceptance feedback of the new product later in the process. It is the responsibility of the KOL surgeon and the development staff to turn that information into a viable product.

 

With the more common traditional surgeon design team, assembling a good design team is critical to the success of the endeavor. The product development team needs to work closely with the marketing department in the selection and assembly of the surgeon design team. The selection process is very much like picking players for a team sport. The desire is to pick the most talented team, with personalities that mesh with each other while becoming aligned to win in the same way.

 

The training and clinical experience of the surgeons, the number of surgeons on the team, and their geographic locations are just a few of the important factors to be considered. The surgeon’s CV is a great reference as are their publications to discover where and by whom they were trained, as well as if they have any won any awards or honors. This process helps an organizer begin to understand a surgeon’s philosophy so as to determine if it matches with the objectives of the project. If these elements do not seem to align, it is best to move on. Further, there are other important considerations—is this the first design team the surgeon has been a part of or is it just the most recent? Has he or she been a part of prior design projects, and if so, what has been the success of those products? You need to fully understand the motivation of a surgeon to be a member of a design team.

 

It is critical the surgeons understand the commitment they will need to make to be part of the design team, as there will be meetings and other activities that will take them away from their clinical practice and surgery. Provide an understanding of the duration of the project and the time periods where their involvement will be greater than other periods as the project progresses. For example, one design project required great commitment from the surgeons as it met approximately every two to three weeks and for full weekends. As a result of the commitment from the surgeons and support of the company, a very large implant/instrument project was conceived and introduced in 18 months. Conversely, projects without full commitment from all surgeons has resulted in the opposite effect, significantly delaying the project, and doubling the anticipated time to market. Therefore, if the surgeon is not willing to commit the time, they are not a good candidate.

 

I have had the opportunity to work with a wide group of surgeons from around the world on numerous design teams. All were excellent surgeons, but their interests and how they assisted the design teams varied greatly. There were some true innovators and designers who would design or create their own drawings of new and innovative products. When the product was introduced, they were willing to stand behind the new concept until it was clinically proven, even in the face of being questioned by traditionalists. Others were known for performing clinical studies or understanding the issues surgeons were facing. Still others offered their strengths in addressing the surgical technique. It is crucial to understand the strengths and weaknesses of the members of the design team.

 

Regarding the project itself, it is vital to have the project well-scoped. The scope needs to be flexible in nature but, at the same time, there need to be boundaries in place to avoid creep and to ensure the end results fulfill the original unmet market requirement. What is the new product or service expected to perform and what is it not going to address? What shouldn’t be addressed is, many times, more important than determining what needs to be. Ensure everyone understands the project’s clinical scope, the financial objectives, and the other innovative aspects desired. In order to keep the team focused and grounded as time progresses, it is often necessary to reflect back upon the scope to avoid derailing and delaying the project.

 

Having the development engineer/staff gain the respect of the surgeon design team is also important. The engineer must have a wide base of knowledge to keep multiple elements of the development project within his or her view. As the process progresses, certain elements of the product are being locked down that impact the long-term commercial success, design attributes, manufacturability, inventory costs, marketing/sales, user experience, and clinical outcomes. Throughout the project, subject matter experts (e.g., the surgeons, manufacturing engineers, etc.) will provide input and support, but the development engineer is ultimately the one who must sift through all the information and recommendations to decide which to accept, modify, or reject. As such, the development engineer must be a jack-of-all-trades. Leading a development program should not be handled as if it is a democracy, but rather, as a benevolent dictatorship. The leader must listen, assess the situation, make a decision, and move on. Attempting to satisfy all parties will only cause delays.

 

There are techniques that can be used to help sort through the issues to attempt to make the best decisions. One technique is to note how many times the same concern is raised. If the issue is repeated by numerous surgeons and/or other advisors, it likely requires further exploration. If it is rarely stated or only by one surgeon, it may be safe to consider it a much lower priority. If the factor significantly impacts cost, however, determine how significantly it could impact the marketability of the product.

 

If a new, creative solution is conceived by a surgeon that seems to have originated from out of left field, it should not be automatically dismissed. Instead, challenge the surgeon to “sell” the idea to the rest of the design team. If he or she cannot earn their acceptance, it may be best to move on. This does not mean the concept was not worthy, but perhaps it needs to be sidelined from the current program and examined independently on its own merits at a later time or for a future generation of the product. Some creative solutions may seem like an idea that makes sense, but ultimately, must be considered within the scope definition for the project.

 

When having a design meeting, it is important to know the outcome ahead of time. Since design meetings can sometimes become confrontational, first addressing key topics individually with surgeons to understand their concerns and issues will provide a means to be better prepared for the full meeting and make it more productive. If there are controversial issues to be addressed, have one of the surgeon designers present them, which can also assist in making the meeting more productive.

 

After the concept for the product design has been finalized, enroll a second group of surgeons not part of the original design team to objectively review the new product concept. This can help ensure market acceptance and help identify issues that may have been overlooked. All members of the design team are too close to the project to objectively review the new product. While this review occurs late in the design process, it is still early enough to allow for modifications to be made relativity inexpensively.

 

Surgeon design teams have been and will continue to be a critical element for the advancement of healthcare in the development of new and innovative medical devices. Leading surgeon design teams is a skill a development engineer needs to hone and refine. It involves technical knowledge, psychology, business acumen, and most importantly, strong leadership attributes.

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FDA Clears IlluminOss Medical's Bone Stabilization System

FDA Clears IlluminOss Medical's Bone Stabilization System | IT Support and Hardware for Clinics | Scoop.it

IlluminOss Medical, a privately held, commercial-stage medical device company focused on minimally invasive orthopedic fracture repair, announced that it has received U.S. Food and Drug Administration (FDA) de novo clearance for the IlluminOss Bone Stabilization System for treatment of impending and actual pathological fractures of the humerus, radius and ulna from metastatic bone disease.

The IlluminOss System incorporates the use of a thin-walled PET balloon that is infused with a liquid monomer and delivered in a minimally invasive fashion into the intramedullary canal of the bone through a small incision.

Once the balloon is infused with monomer, it conforms to the shape of the patient’s specific bone. The surgeon then activates a light source which delivers visible light to the PET balloon, polymerizing the monomer. The cured, hardened implant provides longitudinal strength and rotational stability over the length of the implant, stabilizing the fracture.

The IlluminOss System, which has been commercially available in international markets and been in clinical use since 2010, will now be available to patients in the U.S. for the treatment of pathological fractures of the humerus, radius and ulna.

“The FDA marketing clearance marks a significant milestone for IlluminOss Medical, allowing us to bring our products to the U.S. market,” said Robert Rabiner, chief technology officer, IlluminOss. “The IlluminOss System was developed with an aim to provide improved patient experiences and outcomes when treating pathologic fractures. There is a critical need to make less invasive orthopedic fracture repair options available to an aging and underserved market segment.”

Surgeons’ experiences with the product in the international markets have reported smaller incisions, shorter procedural times, faster return to patient’s daily living activities, with reduced hospital stays and lower complication rates for patients.

“The IlluminOss System has significantly changed the way we are able to approach the treatment of certain impending and actual pathological fractures resulting from metastatic bone disease,” said Dr. Richard McGough, Department of Orthopaedic Surgery, University of Pittsburgh Medical Center. “We were able to offer patients a quick, reliable surgical option that minimized pain and hospitalization. We were also able to consolidate their treatments; in some cases, we moved from two-day admissions to outpatient surgery, and we were ultimately able to complete radiation much more quickly.”

“I am delighted that we now have an improved option to help patients with metastatic bone disease of the humerus,” said John Healey, Chief of Orthopaedic Surgery, Memorial Sloan Kettering Cancer Center. “Since this device doesn’t violate the rotator cuff and can be inserted with reduced operative time and blood loss, it relieves pain and restores function more effectively than alternative treatments, in my experience. Furthermore, this new technology is versatile, and I anticipate that new applications will follow.”

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Nerve-on-a-Chip Platform Makes Neuroprosthetics More Effective

Nerve-on-a-Chip Platform Makes Neuroprosthetics More Effective | IT Support and Hardware for Clinics | Scoop.it

Neuroprosthetics—implants containing multi-contact electrodes that can substitute certain nerve functionalities—have the potential to work wonders. They may be able to restore amputees' sense of touch, help the paralyzed walk again by stimulating their spinal cords and silence the nerve activity of people suffering from chronic pain. Stimulating nerves at the right place and the right time is essential for implementing effective treatments, but still a challenge due to implants' inability to record neural activity precisely. "Our brain sends and receives millions of nerve impulses, but we typically implant only about a dozen electrodes in patients. This type of interface often doesn't have the resolution necessary to match the complex patterns of information exchange in a patient's nervous system," said Sandra Gribi, a Ph.D. student at the Bertarelli Foundation Chair in Neuroprosthetic Technology.

Replicating—and Improving—How Neuroprosthetics Work
Scientists at the lab run by Dr. Stéphanie Lacour, a professor at EPFL's School of Engineering, have developed a nerve-on-a-chip platform that can stimulate and record from explanted nerve fibers, just as an implanted neuroprosthetic would. Their platform contains microchannels embedded with electrodes and explanted nerve fibers faithfully replicate the architecture, maturity, and functioning of in vivo tissue.

The scientists tested their platform on explanted nerve fibers from rats' spinal cords, trying out various strategies for stimulating and inhibiting neural activity. "In vitro tests are usually carried out on neuron cultures in dishes. But these cultures don't replicate the diversity of neurons, like their different types and diameters, that you would find in vivo. Resulting nerve cells' properties are changed. What's more, the extracellular microelectrode arrays that some scientists use generally can't record all the activity of a single nerve cell in a culture," said Gribi.

The nerve-on-a-chip platform developed at EPFL can be manufactured in a clean room in two days and is able to rapidly record hundreds of nerve responses with a high signal-to-noise ratio. However, what really sets it apart is that it can record the activity of individual nerve cells. The research has just been published in Nature Communications.

Inhibiting the Activity of Specific Neurons
The scientists used their platform to test a photothermic method for inhibiting neural activity. "Neural inhibition could be a way to treat chronic pain like the phantom limb pain that appears after an arm or leg has been amputated, or neuropathic pain," said Lacour.

The scientists deposited a photothermic semiconducting polymer, called P3HT:PCBM, on some of the chip's electrodes. "The polymer heats up when subject to light. Thanks to the sensitivity of our electrodes, we were able to measure a difference in activity between the various explanted nerve fibers. More specifically, the activity of the thinnest fibers was dominantly blocked," said Gribi. And it's precisely those thin fibers that are nociceptors—the sensory neurons that cause pain. The next step will be to use the polymer in an implant placed around a nerve to study the inhibiting effect in vivo.

Distinguishing Between Sensory and Motor Nerve Fibers
The scientists also used their platform to improve the geometry and position of recording electrodes, in order to develop an implant that can regenerate peripheral nerves. By running the measured neural data through a robust algorithm, they will be able to calculate the speed and direction of nerve impulse propagation—and therefore determine whether a given impulse comes from a sensory or motor nerve. "That will enable engineers to develop bidirectional, selective implants allowing for more natural control of artificial limbs such as prosthetic hands," said Lacour.

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'Dual Mobility' Hip Replacement Implant Reduces Risk Of Dislocation

'Dual Mobility' Hip Replacement Implant Reduces Risk Of Dislocation | IT Support and Hardware for Clinics | Scoop.it

Hip replacement surgery is highly successful in relieving pain, restoring mobility, and improving quality of life. More than 330,000 procedures are performed each year in the United States, and that number is expected to almost double by the year 2030.

As with all surgical procedures, the possibility of a complication exists, and dislocation is the most common problem. The risk of dislocation is higher in patients who have had a second hip replacement, known as revision surgery. Some people need revision surgery many years after their first hip replacement when the original implant wears out. Hip instability after joint replacement is another reason a patient might need a revision surgery.

Research conducted by Dr. Geoffrey Westrich and colleagues at Hospital for Special Surgery and other joint replacement centers indicates that a newer type of artificial hip known as a "modular dual mobility" implant could be a good option for patients who need a revision surgery. Their study was presented at the annual meeting of the American Association of Hip and Knee Surgeons in Dallas this month.

"Although the concept of dual mobility was originally developed in France in the 1970s, the technology is relatively new in the United States," said Dr. Westrich, director of research of the Adult Reconstruction and Joint Replacement Service at HSS. "Our study found that the newer technology with modular dual mobility components offered increased stability, lowering the risk of dislocation, without compromising hip range of motion in patients having a revision surgery."

"Dual mobility" refers to the bearing surface of the implant—where the joint surfaces come together to support one's body weight. A hip replacement implant is a ball-in-socket mechanism, designed to simulate a human hip joint. Typical components include a stem that inserts into the femur (thigh bone), a ball that replaces the round head of the thigh bone, and a shell that lines the hip socket.

Modular dual mobility implants provide an additional bearing surface compared to a traditional implant. With the dual mobility hip, a large polyethylene plastic head fits inside a polished metal hip socket component, and an additional smaller metal or ceramic head is snap-fit within the polyethylene head.

"Currently, there are few large-scale outcome studies on the modular dual mobility device in revision hip replacement," Dr. Westrich noted. "We set out to determine the rate of dislocation and the need for another surgery following revision hip replacement using this implant and report on the functional outcomes."

The study included 370 patients who underwent revision hip replacement with the dual mobility implant between April 2011 and April 2017. The average patient age at the time of surgery was 65.8 years. Clinical, radiographic, and patient reported-outcome information was collected.

To be included in the final report, patients needed to be seen for follow-up for at least two years after their surgery, and the average follow-up was 3.3 years. "At the latest follow-up, we found that surgery with the dual mobility implant resulted in a very low rate of instability for the revision patients, namely 2.9 percent, with good functional improvement and a low rate of reoperation," Dr. Westrich noted. "While longer-term follow-up is needed to fully assess the newer device, in our study there was clearly a benefit provided by the dual mobility implant in the first few years following revision surgery."

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Information Technology in Today’s Veterinary Practice -

Information Technology in Today’s Veterinary Practice - | IT Support and Hardware for Clinics | Scoop.it

5 Common challenges of the traditional veterinary practice

  • Paper record keeping, appointment scheduling, service reminder distribution
  • Increased labor cost due to inefficiency
  • Difficulty in accurately managing inventory and accounting
  • Lack of advertisement avenues and initiatives
  • No connection with necessary modern medical equipment, associated practices, or specialty practices

We will now discuss the advantages of moving to a cloud based practice management system.

Why should a practice utilize cloud based technology?

Accuracy of records, reporting, and scheduling

In a paper record practice, patient files can be difficult to locate, reference, and store. Staff may be frequently disorganized, and it may slow the process of patient care. Your staff will likely spend more time shuffling paperwork than providing medical attention.

With a cloud based practice, patient files are easily accessible, updated real-time, and require no physical space for storage. The ability to schedule appointments is streamlined and accurate, reducing client wait-time and cancelled visits.

Increasing client compliance

In a paper record practice, staff is responsible for tracking services due which may lead to missing service reminders or sending redundant communications. But with a cloud based practice, the system does the work for you.  It allows you to send reminders in a variety of ways; postcards, emails, and text messages.

Reducing costs of operation

In a paper record practice, the cost is obvious. The physical storage demands are large and those costs will only continue to grow over time.  The inefficiencies in finding records, tracking service due dates, and communicating with the client is large and are frequently error prone. And in an installed system, you have to worry about the cost of purchasing equipment and updating that equipment.

 

With a cloud based practice, no servers or backups are required which frees up the staff and resources to allow them to provide better patient care. Cloud based systems usually have a low upfront cost with a reasonable monthly subscription price. The monthly price includes the system, automatic updates, support, and training.

Staff productivity and satisfaction

Let’s be honest, most veterinary clinic staff members joined this industry to spend time with animals and to help provide quality care. Managing paper records or an installed system isn’t something they bought into. However, they can leverage their system to help with the quality of care.

 

With a cloud based practice, staff can become more efficient giving them more time to do what they love which is being with the patient and providing that care. A happier staff normally translates to higher revenue.

Client interaction and communication

For a paper record practice, client interaction is limited to office visits, phone calls, and direct mailings. But with a cloud based practice, you get all those plus the ability to email, text message, client portal (pet portal), and social media.

Business growth and expansion

The record keeping process with which you run your practice shouldn’t prevent growth. Using paper records will take a toll on resources and will stifle growth.  An installed system will require more upkeep as hardware becomes outdated.  It is also very common to start with a hardware setup to support your clinic, but then grow out of that hardware setup. This would require new hardware and servers.

With a cloud based practice, servers are managed by the software vendor and are set up to grow with the business.

Medical technology and cross practice connectivity

For a paper record practice, there is no option to seamlessly pull in lab results, radiographs, or specialists’ reports – they must all be stored separately.  Coordinating this with a multi-location practice is near impossible.

With an install system, you can at least connect your software to external devices like lab analyzers and x-ray equipment. However, you can’t easily connect multi-location practices.

With a cloud based system, you can do both and do both well. In a multi-location practice, you can easily access one or more clinics from the same computer or device. You can also share clients and patients across locations reducing double entry. In most cases, you can run reports that show a group practice view which is near impossible with paper or installed systems.

Eddie Heinz is the CEO of eVetPractice.com, a leading provider of veterinary practice management software. Founded in 2011, the company’s clientele spans more than 40 states within the United States, as well as Canada and Australia.

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