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Fitbit Data Being Used In Personal Injury Case

Posted on December 8, 2014 I Written By

Anne Zieger is veteran healthcare consultant and analyst with 20 years of industry experience. Zieger formerly served as editor-in-chief of FierceHealthcare.com and her commentaries have appeared in dozens of international business publications, including Forbes, Business Week and Information Week. She has also contributed content to hundreds of healthcare and health IT organizations, including several Fortune 500 companies. Contact her at @ziegerhealth on Twitter or visit her site at Zieger Healthcare.

Lately, there’s been a lot of debate over whether data from wearable health bands is useful to clinicians or only benefits the consumer user. On the one hand, there are those that say that a patient’s medical care could be improved if doctors had data on their activity levels, heart rate, respirations and other standard metrics. Others, meanwhile, suggest that unless it can be integrated into an EMR and made usable, such data is just a distraction from other more important health indicators.

What hasn’t come up in these debates, but might far more frequently in the future,  is the idea that health band data can be used in personal injury cases to show the effects of an accident on a plaintiff. According to Forbes, a law firm in Calgary is working on what may be the first personal injury case to leverage smart band data, in this case activity data from a Fitbit.

The plaintiff, a young woman, was injured in an accident four years ago. While Fitbit hadn’t entered the market yet, her lawyers at McLeod Law believe they can establish the fact that she led an active lifestyle prior to her accident. They’ve now started processing data from her Fitbit to show that her activity levels have fallen under the baseline for someone of her age and profession.

It’s worth noting that rather than using Fitbit data directly, they’re processing it using analytics platform Vivametrica, which uses public research to compare people’s activity data with that of the general population. (Its core business is to analyze data from wearable sensor devices for the assessment of health and wellness.) The plaintiff will share her Fitbit data with Vivametrica for several months to present a rich picture of her activities.

Using even analyzed, processed data generated by a smart band is “unique,” according to her attorneys. “Till now we’ve always had to rely on clinical interpretation,” says Simon Muller of McLeod Law. “Now we’re looking at longer periods of time to the course of the day, and we have hard data.”

But even if the woman wins her case, there could be a downside to this trend. As Forbes notes, insurers will want wearable device data as much as plaintiffs will, and while they can’t force claimants to wear health bands, they can request a court order demanding the data from whoever holds the data. Dr. Rick Hu, co-founder and CEO of Vivametrica, tells Forbes that his company wouldn’t release such data, but doesn’t explain how he will be able to refuse to honor a court-ordered disclosure.

In fact, wearable devices could become a “black box” for the human body, according to Matthew Pearn, an associate lawyer with Canadian claims processing firm Foster & Company. In a piece for an insurance magazine, Pearn points out that it’s not clear, at least in his country, what privacy rights the wearers of health bands maintain over the data they generate once they file a personal injury suit.

Meanwhile, it’s still not clear how HIPAA protections apply to such data in the US. When FierceHealthIT recently spoke with Deven McGraw, a partner in the healthcare practice of Manatt, Phelps & Phillips, she pointed out that HIPAA only regulates data “in the hands of, with the control of, or within the purview of a medical provider, a health plan or other covered entity under the law.”  In other words, once the wearable data makes it into the doctor’s record, HIPAA protections are in force, but until then they are not.

All told, it’s pretty sobering to consider that millions of consumers are generating wearables data without knowing how vulnerable it is.

Adverse Event Reporting: What Is It?

Posted on December 3, 2014 I Written By

When Carl Bergman isn't rooting for the Washington Nationals or searching for a Steeler bar, he’s Managing Partner of EHRSelector.com, a free service for matching users and EHRs. For the last dozen years, he’s concentrated on EHR consulting and writing. He spent the 80s and 90s as an itinerant project manger doing his small part for the dot com bubble. Prior to that, Bergman served a ten year stretch in the District of Columbia government as a policy and fiscal analyst.

Eric Duncan’s Ebola death in Dallas was, to say the least, an adverse event (AE). Famously now, when he had a high fever, pronounced pain, etc., he went to Texas Health’s Presbyterian Hospital’s ER, and was sent home with antibiotics. Three days later much worse, he came back by ambulance.

In the aftermath of Duncan’s death, the hospital’s EHR, EPIC, came in for blame, though it was later cleared. Many questions have come from Duncan’s death including how our medical system handles such problems. Articles often use the term adverse event, but rarely mention reporting. I think it’s important to take a direct look at our adverse event reporting systems and where EHR and AEs are headed. This blog post looks at AE systems. The next will look at where EHRs fit in.

The FDA: Ground Zero for Adverse Event Reports

HHS’ Food and Drug Administration has prime, but not exclusive, jurisdiction over adverse reports breaking them into three classes:

  • Medicines
  • Medical Devices, and
  • Vaccines.

Four FDA systems cover these classes:

  • FAERS. This is FDA’s system for drug related adverse reports. It collects information for FDA’s post marketing for drug and biologic product surveillance. For example, if there’s a problem with Prozac, it’s reported here.
  • MAUDE. The Manufacturer and User Facility Device Experience reporting system. If an X-Ray machine malfunctions or lab equipment operates defectively, this is where the report goes.
  • VAERS. Vaccine adverse reports are collected here.
  • MEDSUN. This is voluntary, device reporting system gathers more detailed information than MAUD. It’s run by as a collaboration of the FDA and several hundred hospitals, clinics, etc. (Disclosure: My wife was MAUD project system developer.) MEDSUN captures details and incidents, such as close calls or events that may have had a potential for harm, but did not cause any. MEDSUN has two subsystems, HeartNet, which is for electrophysiology labs and KidNet for neonatal and pediatric ICUs.
DSC04388

MEDSUN Reporting Poster

State Adverse Event Reporting Systems

Several states require Adverse Event reporting in addition to FDA reports. Twenty-seven states and DC require Adverse Event reports, with varying coverage and reporting requirements. Some states, such as Pennsylvania, have an extensive, public system for reporting and analysis.

Patient Safety Organizations

Added to federal and state organizations are many patient safety organizations (PSOs) with an Adverse Event interest. Some are regional or state groups. Others, are national non profits, such as the ECR Institute.

The Safety Reporting Paradox

If you delve into an Adverse Event reporting systems, you’ll quickly see some institutions are more present than others. That doesn’t necessarily mean they are prone to bad events. In fact, these may be the most safety conscious who report more of their events than others. Moreover, high reporters often have policies that encourage AE reporting to find systemic problems without punitive consequences.

Many safety prevention systems work this way. Those in charge recognize it’s important to get all the facts out. They realize adopting a punitive approach drives behavior underground.

For example, the FAA has learned this the hard way. Recently on vacation, I met two air traffic controllers who contrasted the last Bush administration’s approach to now. Under Bush’s FAA errors were subject to public shaming. The result was that many systemic problems were hidden. Now, the FAA encourages reporting and separates individual behavior. The result is that incidents are more reported and more analyzed. If individual behavior is culpable, it’s addressed as needed.

In the next part, I’ll look at how EHRs fit into the current system and the congressional efforts to exempt them from reporting AEs, a move that I think is akin to putting pennies in a fuse box.

Microsoft Joins Battle for Wearables Market

Posted on November 4, 2014 I Written By

Anne Zieger is veteran healthcare consultant and analyst with 20 years of industry experience. Zieger formerly served as editor-in-chief of FierceHealthcare.com and her commentaries have appeared in dozens of international business publications, including Forbes, Business Week and Information Week. She has also contributed content to hundreds of healthcare and health IT organizations, including several Fortune 500 companies. Contact her at @ziegerhealth on Twitter or visit her site at Zieger Healthcare.

Following the lead of several other companies big and small, Microsoft has jumped into the wearables healthcare market with a watch, a fitness tracker and a cloud-based platform that condenses and shares data.

It’s little wonder. After a few years of uncertainty, it seems pretty clear that the wearables market is taking off like a rocket. In fact, 21% of US consumers own such a device, according to research by PricewaterhouseCoopers. That’s slightly higher that the number of consumers who bought tablets during the first two years after they launched, PwC reports. Not only Microsoft, but Apple and Samsung, as well as smaller players with a high profile — such as Fitbit — are poised to take the sector by storm.

Microsoft’s new entry is called Microsoft Health, a platform letting users store health and fitness data. The date in question is collected by a Microsoft Health app, available on Android, iOS and Windows Phone. The platform also gathers data generated from the Microsoft Band, a smart and designed to work with Microsoft’s new platform.

The idea behind pulling all of this data into a single platform is to integrate data from different devices and services in a smart way that allows consumers to generate insights into their health. The next step for Microsoft Health, execs say, is to connect all of that data in the platform to the tech giant’s HealthVault, a Web-based PHR, making it easier for people to share data with their healthcare providers.

Other tech giants are making their own wearables plays, of course. Google, for example, has released Google Fit, a fitness-based app designed to help users track physical activity. Google’s approach is  Android smart phones, relying on sensors built into the smart phones to detect if the user is walking, running or biking. Users can also connect to devices and apps like Noom Coach and Withings.

Apple, for its part, has launched HealthKit, its competing platform for collecting data from various health and fitness apps.  The data can then be accessed easily by Apple users through the company’s Health app (which comes installed on the iPhone 6.) HealthKit is designed to send data directly to hospital and doctor charts as well. It also plans to launch a smart watch early next year.

While there’s little doubt consumers are interested in the wearables themselves, it’s still not clear how enthusiastic they are about pulling all of their activity onto a single platform. Providers might be more excited about taming this gusher of data, which has proved pretty intimidating to doctors already overwhelmed with standard EMR information, but it remains to be seen whether they’ll find fitness information to be helpful.

All told, it looks like there will be a rollicking battle for the hearts and minds of wearables consumers, as well as the loyalty of providers.  As for me, I think it will be a year or two, at minimum, before we get a real sense of what consumers and providers really want from these devices.

What if the FDA Started Regulating EHR?

Posted on March 20, 2014 I Written By

John Lynn is the Founder of the HealthcareScene.com blog network which currently consists of 10 blogs containing over 8000 articles with John having written over 4000 of the articles himself. These EMR and Healthcare IT related articles have been viewed over 16 million times. John also manages Healthcare IT Central and Healthcare IT Today, the leading career Health IT job board and blog. John is co-founder of InfluentialNetworks.com and Physia.com. John is highly involved in social media, and in addition to his blogs can also be found on Twitter: @techguy and @ehrandhit and LinkedIn.

In the world of mobile health, we’ve often talked about what will happen if the FDA starts to regulate the various mobile health apps out there. In fact, the FDA has come out with some pretty detailed guidelines on what mobile health applications and devices need FDA clearance. To date, the FDA has stayed away from any regulation of EHR software.

On my ride to the airport after the Dell Healthcare Think Tank event, we had an interesting and engaging conversation about the FDA when it comes to EHR software. Some of the discussion was around whether the FDA would start regulating EHR software.

Shahid Shah suggested that it was extremely unlikely that the FDA would touch EHR software at least until meaningful use was complete and the current President was out of office. He rightfully argues that this administration has hung their hat on EHR and the FDA wasn’t going to step in and stop that program. Plus, Shahid suggested that ONC wouldn’t let the FDA do it either. Janet Marchibroda from the Bipartisan Policy Center was hopeful that Shahid was right, but wasn’t as confident of this analysis.

After hearing them discuss this, I asked them the question:

What would happen to the EHR Market if the FDA started regulating EHR?

Shahid quickly responded that the majority of EHR vendors would go out of business and only a small handful of companies would go through the FDA clearance process. Then, he suggested that this is exactly why the FDA won’t regulate EHR software. FDA regulation of EHR would wipe out the industry.

This is a really interesting question and discussion. The reality is that there are a lot of similarities between EHR software and medical devices. One could make a really good case for why the FDA should regulate it like medical devices. One could make a case for the benefit of some rigor in the development of EHR software. However, there’s no appetite for such a change. In fact, the only people I’ve seen calling for it are those who think that EHR is unusable and potentially harmful to patients. I’m not sure FDA regulation will make them more usable though.

Now, juxtaposition the above conversation with this post by William Hyman titled “A Medical Device Recall of an EHR-like Product” In this case, the FDA announced McKesson’s voluntary recall of it’s Anesthesia Care system. This software was tightly integrated with other FDA regulated medical devices. I wonder what this means for other EHR software that is starting to integrate with a plethora of FDA cleared medical devices and other non FDA cleared medical devices.

I’m personally with Shahid in that I don’t think the FDA is going to touch EHR software with a long pole. At least, not until after meaningful use. After meaningful use, I guess we’ll see what they decide to do.

Epic EMR Training, Glucometer Workflow, New Media Meetup & MU Success

Posted on January 26, 2014 I Written By

John Lynn is the Founder of the HealthcareScene.com blog network which currently consists of 10 blogs containing over 8000 articles with John having written over 4000 of the articles himself. These EMR and Healthcare IT related articles have been viewed over 16 million times. John also manages Healthcare IT Central and Healthcare IT Today, the leading career Health IT job board and blog. John is co-founder of InfluentialNetworks.com and Physia.com. John is highly involved in social media, and in addition to his blogs can also be found on Twitter: @techguy and @ehrandhit and LinkedIn.


I think this is true for all EMR software, but particularly so for Epic. It’s always amazing how many skimp on EMR training and then pay the price for it later.


It’s a little hard to see, but illustrates the challenge associated with connecting these external data devices. It’s going to take a while for this to be commonplace and normal. I do find it interesting that they’re using Direct and the hardest interface to build (sending info to the EHR) is “Out of Pilot Scope.” I guess they don’t want to take on the hard stuff in the pilot.

These next 2 tweets are a little self serving since they point to posts on my EMR and HIPAA site. If you’re not subscribed to that site, you should go and do that now. Plus, one of these tweets is about a party at HIMSS, so I don’t imagine I’ll get any complaints there.


I hope to see many of you at HIMSS 2014!


I appreciate Dr. Webster recognizing this as a good one. While I’m biased, I think it’s a really important topic that needs more discussion. Although, I’m pretty sure it won’t be getting me an invite to any ONC dinner parties.

Consumers Are Ready For Wearable Tech

Posted on January 15, 2014 I Written By

Anne Zieger is veteran healthcare consultant and analyst with 20 years of industry experience. Zieger formerly served as editor-in-chief of FierceHealthcare.com and her commentaries have appeared in dozens of international business publications, including Forbes, Business Week and Information Week. She has also contributed content to hundreds of healthcare and health IT organizations, including several Fortune 500 companies. Contact her at @ziegerhealth on Twitter or visit her site at Zieger Healthcare.

Though they’re pretty, interesting and fun, I’ve never taken wearable devices that seriously as a force that could have impact on healthcare delivery in the here and now.  Well, it seems that I was wrong.  While it’s not certain that the health system can afford these devices — they don’t exactly come in at an easy consumer price point — it seems consumers are ready to use them if given the chance.

According to a new study by Accenture, more than half of consumers “are interested in buying wearable technologies such as fitness monitors for tracking physical activity in managing their personal health,” according to a report in Health IT Outcomes.

According to Accenture, consumers were primarily interested in devices like smart watches and wearable smart glasses such as Google Glass, even though these devices are not yet available commercially.  Consumers were also very interested in phablets, an emerging device category combining smart phone and tablet PC functions.

I can’t help think that this is a very positive trend.  For one thing, consumer wearables can be an important gateway to remote patient monitoring, something that’s less likely with devices that are used and put aside, like wired glucose monitors, pulse oximeters and blood pressure cuffs.

What’s more, wearables can fit into a healthcare ecosystem in which devices talk to one another and other wireless systems (such as their desktop, laptop or smart phone), whereas the other smart devices I’ve mentioned have less flexibility in that arena.

So, who pays for the wearables?  At least at first, it will probably make more sense for providers to invest in these devices and use them to conduct tests of remote patient monitoring and its impact on care.

But as consumers pick up the wearables themselves, providers might want to focus on building a network which seamlessly integrate these devices, as it seems almost a given that consumers will buy them when they’re available and affordable.  It will take years to get that right, so now it’s probably time to start. Get prepared for the Internet of everything!

Forrester’s Take On Computing Trends For Next Year

Posted on December 31, 2013 I Written By

Anne Zieger is veteran healthcare consultant and analyst with 20 years of industry experience. Zieger formerly served as editor-in-chief of FierceHealthcare.com and her commentaries have appeared in dozens of international business publications, including Forbes, Business Week and Information Week. She has also contributed content to hundreds of healthcare and health IT organizations, including several Fortune 500 companies. Contact her at @ziegerhealth on Twitter or visit her site at Zieger Healthcare.

Recently, Forrester Research’s J.P. Gownder released a list of six broad tech trends he feels will dominate 2014. While they’re not healthcare-specific, I thought our readers would appreciate them, as they are relevant to the work that we do.

Mobility:  Gownder is arguing that this year coming will see a “sustained mobile mind shift.” He argues that customers and employees are beginning to expect that the data they touch will be available to them in context on any device at the exact what would’ve need. He argues that customers will actively shun businesses that lack mobile applications.

Fragmentation:  While vendors would like to see us, as consumers, stick to one vendor and operating system, Gownder argues that just the opposite will happen in 2014, with people trading off between multiple devices and thriving across operating systems. This movement, driven by the seeming infinity of new mobile devices, makes things more difficult for health IT administrators, to be certain.

Wearables:  While the wearables devices your editor has seen strike her mostly as toys, Gownder is far more enthusiastic. He argues that next year will see commercial availability of a range of once theoretical wearables — and that enterprise wearables have a particularly rich future ahead of them.

Intelligent assistants:  For me, services like Siri and Samsung’s S-Voice are entertaining, but hardly add anything to the mix when it comes to what your phone tablet or PC can do. Gownder, however, believes that intelligent assistance will rise to prominence in 2014 as they become more sophisticated, interesting and useful.

Gestural computing: Expect to see new applications and scenarios for gestural computing this year, Gownder predicts, driven by phenomena like the presence of XBox Kinect in tens of millions of homes, the emergence of Leap Motion and the emergence of a new device known as Myo from Thalmic Labs. In this case he isolates healthcare specifically as a strong use case, in which professionals manipulate and navigate medical imaging using gestures.

Stores recognize you: Here’s one I can see direct healthcare applications for; next year, Gownder predicts, will be the year in which you walk into a store and the store “recognizes you” and tailors your experience accordingly. I can see this being relevant in virtually any public-facing healthcare setting, including the ED, medical clinics and perhaps even EMT settings. Sounds very much like John’s description of a “biometrically controlled healthcare system.

So which of these trends do you think will be the most important next year? How are you adopting them, if at all, in your healthcare organization?

Windows 8 Enables Healthcare Tablet Adoption

Posted on August 20, 2013 I Written By

John Lynn is the Founder of the HealthcareScene.com blog network which currently consists of 10 blogs containing over 8000 articles with John having written over 4000 of the articles himself. These EMR and Healthcare IT related articles have been viewed over 16 million times. John also manages Healthcare IT Central and Healthcare IT Today, the leading career Health IT job board and blog. John is co-founder of InfluentialNetworks.com and Physia.com. John is highly involved in social media, and in addition to his blogs can also be found on Twitter: @techguy and @ehrandhit and LinkedIn.

The following is a guest post by Scott Thie, Vice President, Healthcare and Education, Panasonic
Scott Thie - VP of Healthcare and Education at Panasonic
Technology is evolving at light speed, and the way healthcare providers work is changing with it.

Mobile computing technology that was unimaginable five years ago is now commonplace, and has driven efficiency and productivity in healthcare by leaps and bounds. Doctors, nurses and healthcare administrators now have the ability to work from virtually anywhere, storing data “in the cloud” and staying constantly linked to the patient and one another.                   

One of the primary computing devices enabling this mobile evolution has been the tablet – a light weight, powerful and easy-to-use device that has gone from a niche product to widespread healthcare enterprise adoption. Tablets are an excellent way to boost mobility and workflow efficiency, and their role in healthcare continues to grow. Tablets’ portability, flexibility and ease of use have made them a great fit for health business applications of all kinds. In fact, over the next five years total shipments of tablet computers to enterprises around the world are expected to increase at a compound annual growth rate of 48%, according to Infinite Research.

It’s clear that tablets offer improved productivity and mobility, but this technology evolution has not come without its growing pains. In many cases, tablets are so attractive to users that many of them have not waited for their employers to issue them; they’ve brought their own personal devices to work. In other cases, healthcare providers have issued devices to their staff that are better suited for consumer use and lack critical security, durability and functionality features. This has resulted in a fragmented IT management landscape consisting of myriad devices with different operating systems, security challenges and support needs.

Recently, the technology industry has seen a shakeup that could play a large role in addressing this issue. Last fall, Microsoft released Windows 8, the most dramatic overhaul of its operating system since 1995. Offering a redesigned interface and several new features, the operating system is built for mobility, security and manageability. And when paired with enterprise-class hardware, Windows 8 opens the door for healthcare providers to embrace the benefits of tablets, without sacrificing on security, functionality and management capabilities.

Windows 8 Advantages

One of the most obvious benefits of Windows 8 is its redesigned metro interface. Built to take advantage of touchscreen technology, the interface offers enterprise professional users the fast and fluid efficiency and personalization found on today’s popular consumer devices. The operating systems use of swipe, tap and drag gestures allows users to easily switch between applications and multitask. While multitasking is a business reality, it’s a challenge for some tablet operating systems, potentially limiting worker productivity. The Windows 8 interface also includes live updating tiles, which can help business users retain situational awareness.

With the recent boom in mobile devices, many healthcare IT departments have been forced to integrate incoming tablets – with alternative operating systems and potential security risks – into legacy device management, security, and system integration structures. It can be difficult to securely and efficiently integrate mobile devices with newer operating systems like Android or iOS into a legacy Windows IT infrastructure, and often puts healthcare administrators into a “troubleshooting” mode instead of devoting their resources to ensure optimal patient care.

Designed with mobile productivity in mind, Windows 8 allows providers to avoid compromising on mobility, functionality and security by integrating seamlessly with legacy enterprise IT infrastructure. With Windows 8, users have the ability to use the same operating system in desktop and tablet environments. Not only is the IT department supporting a single operating system, users benefit from a seamless and familiar operating environment across all their devices.

Security is a critical need in healthcare technology, and Windows 8 offers several features not found in many other tablet operating systems. Secure Boot, for example, is a boot-up process that helps prevent malware from running at startup. Unlike some mobile app download services, Microsoft vets each app included in the Windows Store for quality and safety before making it available for download.

From an IT management perspective, a key benefit of Windows 8 is its ability to work with existing software and hardware. Many business-critical applications, especially in the healthcare segment, are designed to run on Windows. It’s also integrated into the enterprise in other ways, such as the many third-party cloud and software-as-a-service providers using Active Directory for identity management. Windows 8 works with mobile device management (MDM) systems as well, including offering features to secure devices from unauthorized use.

Choosing the Right Device

Equally important as the operating system is the right hardware. Purpose-built tablets, designed specifically for challenging environments, offer the durability, ease of use and warranty support that healthcare providers require, without compromising on security or manageability.

Before investing in a tablet deployment, verify that the device will offer the features your care providers and healthcare facility demand. Something as simple as a user-replaceable battery, which many consumer devices lack, could be a potential life-saver for doctors and nurses remotely accessing critical patient data. In other cases, it may be as simple as a tablet with a daylight-viewable screen, which ensures a clinician can work efficiently regardless of lighting challenges. Some hospital workers may need a device that can be used with a digitizer pen for signature capture or an all-touch interface for easy manipulation of medical images or text.

The most common causes of mobile computer failures are drops and spills. These dangers are magnified for healthcare mobile workers. Tablets should be engineered to be rugged enough to withstand a fall to a hard surface, sealed to withstand spills and dust, and easily sanitized help to ensure reliable operation.

With computer hardware such as tablets, it’s also important to understand the difference between price and cost. Even at an enterprise level, it’s natural to gravitate toward the lowest sticker price. However, if that device has a high failure rate, hinders productivity, lacks enterprise-level support or has a short standard warranty, it will end up costing more in the long run – not just in replacement costs but also labor costs, inefficiency, the loss of critical data, reduced patient satisfaction and more. Think about products in terms of their total cost of ownership in order to get the most for your money.

Tablets represent a turning point for the healthcare industry, with the promise of new efficiencies, methods of decision-making and competitive advantage. By making the right technology decisions, healthcare providers can ensure their physicians, nurses and medical staff are equipped to take advantage of these gains without compromise.

Scott Thie is Vice President of the Healthcare & Education Sectors for Panasonic System Communications Company of North America (PSCNA). He is a 24 year veteran of the technology industry and has been with Panasonic since 1998.

Scott began his career at Panasonic as an Area Sales Manager. He was promoted to Regional and then National Sales Manager before his current position. Scott has been recognized several times with awards including Rookie of the Year and Area Sales Manager of the Year. He successfully developed Panasonic’s Field Service Vertical and managed its growth for five years. During his career, he has held positions in sales and sales management, as well as management of marketing, business development and sales engineering. Scott’s current challenge is driving growth and extensively expanding PSCNA’s Healthcare Sector. Before joining Panasonic, Scott was District Sales Manager at Alps Electric, a company specializing in printers and OEM PC components. He was also Regional Sales Manager for Philips Electronics. Scott holds a BS degree in marketing with a minor in sales management from Ferris State University.

Developing Safety Critical Healthcare Software

Posted on June 21, 2013 I Written By

John Lynn is the Founder of the HealthcareScene.com blog network which currently consists of 10 blogs containing over 8000 articles with John having written over 4000 of the articles himself. These EMR and Healthcare IT related articles have been viewed over 16 million times. John also manages Healthcare IT Central and Healthcare IT Today, the leading career Health IT job board and blog. John is co-founder of InfluentialNetworks.com and Physia.com. John is highly involved in social media, and in addition to his blogs can also be found on Twitter: @techguy and @ehrandhit and LinkedIn.

The Healthcare IT Guy, Shahid Shah, has a great post up on his blog about writing safety critical software using an agile, risk-based approach. Here’s a portion of the blog post where Shahid really hits the nail on the head:

Much of that [every software being custom] changed in the 90’s and then upended even further in the early part of the 21st century; we should no longer weighed down by the baggage of the past.These days even our hardware is agile and extensible, real-time operating systems are plentiful, software platforms are malleable, mHealth is well established, and programming languages are sophisticated so we need to be open to reconsidering our development approaches, especially risk-based agile.

Why should we use “risk-based” agile? Because not every single line of code in software can or should be treated equally – some parts of our medical device software can kill people, many parts merely annoy people, but most other parts simply aren’t worth the same attention as the safety-critical components. When you treat every line of code the same (as is often true in a plan-driven approach) and you have a finite amount of resources and time you end up with lower quality software and less reliable medical devices. It’s not fair to blame the FDA for our own bad practices.

I’m always amazed by Shahid’s knowledge and ability to describe something in simple terms. I should know since I’m often on calls with Shahid since he’s my partner in Influential Networks and Physia.

The irony is that in the EHR and mHealth world you could argue that many have taken too much of a lean approach to building their applications while the medical device world treats every part of the software as a patient safety issue. Now if we could just bring the two together into a more reasonable balance of what’s important from the safety side and what’s not.

As far as I can tell, the FDA is planning to mostly stay out of regulating the general mHealth and EHR side of healthcare IT and will stick to the medical devices and mHealth devices that fit under the medical device term. I think this is generally a good thing for a number of reasons. Not the least of which is that the FDA doesn’t have the expertise needed to regulate EHR software. However, I wouldn’t mind a touch more patient safety concern from EHR vendors. Maybe the EHR Code of Conduct will help add a little more to this concern.

Of course, as Shahid points out, you don’t have to sacrifice agile software development to develop safety critical software. This is true in medical device development, EHR development, and even mHealth development.

eHealth Pilot Helps Chronically Ill

Posted on May 28, 2013 I Written By

Anne Zieger is veteran healthcare consultant and analyst with 20 years of industry experience. Zieger formerly served as editor-in-chief of FierceHealthcare.com and her commentaries have appeared in dozens of international business publications, including Forbes, Business Week and Information Week. She has also contributed content to hundreds of healthcare and health IT organizations, including several Fortune 500 companies. Contact her at @ziegerhealth on Twitter or visit her site at Zieger Healthcare.

An 18-month pilot in one of Rio de Janeiro has demonstrated that even a small amount of health IT tools, applied to the right population, can have a significant effect on targeted patients’ health.

To conduct the pilot, the New Cities Foundation and GE Healthcare set out to test out a model which would improve access to primary care in a poor urban community, reports PMLive. (Note: The New Cities Foundation was established by GE, Cisco and Ericsson.)

The partners gave a clinic in the Santa Marta favela in Rio a GE-created eHealth kit, capable of fitting in a backpack, which contained a set of tools to measure key health indicators.  The materials in the kit, if purchased by outside parties, would usually cost about $42,000.

Clinic staff used the portable set of tools to visit 100 elderly patients living with chronic illness and mobility issues, in an effort to offer these patients a comprehensive diagnosis, the publication said.

According to a report created on the project by the Foundation, the results were substantial. Cost savings due to avoiding adverse clinical events included $4,000 (heart failure) to $200,000 (kidney failure) per 100 elderly patients.  Meanwhile, the pilot saved $136,000 per 1,000 patients by avoiding hospitalizations of those with cardiovascular diseases.

Time and time again, research shows that proactively providing preventive care takes costs out of the health system. This model, which seems like it could be duplicated easily in the U.S., should be tested widely in urban “health deserts” here. Any approach which brings primary care to where the frail, immobile elderly are seems almost guaranteed to be a winner.