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IBM Watson Partners With FDA On Blockchain-Driven Health Sharing

Posted on January 16, 2017 I Written By

Anne Zieger is a healthcare journalist who has written about the industry for 30 years. Her work has appeared in all of the leading healthcare industry publications, and she's served as editor in chief of several healthcare B2B sites.

IBM Watson Health has partnered with the FDA in an effort to create scalable exchange of health data using blockchain technology. The two will research the exchange of owner-mediated data from a variety of clinical data sources, including EMRs, clinical trial data and genomic health data. The researchers will also incorporate data from mobiles, wearables and the Internet of Things.

The initial project planned for IBM Watson and the FDA will focus on oncology-related data. This makes sense, given that cancer treatment involves complex communication between multispecialty care teams, transitions between treatment phases, and potentially, the need to access research and genomic data for personalized drug therapy. In other words, managing the communication of oncology data is a task fit for Watson’s big brain, which can read 200 million pages of text in 3 seconds.

Under the partnership, IBM and the FDA plan to explore how the blockchain framework can benefit public health by supporting information exchange use cases across varied data types, including both clinical trials and real-world data. They also plan to look at new ways to leverage the massive volumes of diverse data generated by biomedical and healthcare organizations. IBM and the FDA have signed a two-year agreement, but they expect to share initial findings this year.

The partnership comes as IBM works to expand its commercial blockchain efforts, including initiatives not only in healthcare, but also in financial services, supply chains, IoT, risk management and digital rights management. Big Blue argues that blockchain networks will spur “dramatic change” for all of these industries, but clearly has a special interest in healthcare.  According to IBM, Watson Health’s technology can access the 80% of unstructured health data invisible to most systems, which is clearly a revolution in the making if the tech giant can follow through on its potential.

According to Scott Lundstrom, group vice president and general manager of IDC Government and Health Insights, blockchain may solve some of the healthcare industry’s biggest data management challenges, including a distributed, immutable patient record which can be secured and shared, s. In fact, this idea – building a distributed, blockchain-based EMR — seems to be gaining traction among most health IT thinkers.

As readers may know, I’m neither an engineer nor a software developer, so I’m not qualified to judge how mature blockchain technologies are today, but I have to say I’m a bit concerned about the rush to adopt it nonetheless.  Even companies with a lot at stake  — like this one, which sells a cloud platform backed by blockchain tech — suggest that the race to adopt it may be a bit premature.

I’ve been watching tech fashions come and go for 25 years, and they follow a predictable pattern. Or rather, they usually follow two paths. Go down one, and the players who are hot for a technology put so much time and money into it that they force-bake it into success. (Think, for example, the ERP revolution.) Go down the other road, however, and the new technology crumbles in a haze of bad results and lost investments. Let’s hope we go down the former, for everyone’s sake.

The “Disconnects” That Threaten The Connected World

Posted on January 11, 2017 I Written By

Anne Zieger is a healthcare journalist who has written about the industry for 30 years. Her work has appeared in all of the leading healthcare industry publications, and she's served as editor in chief of several healthcare B2B sites.

I’m betting that most readers are intimately familiar with the connected health world. I’m also pretty confident that you’re pretty excited about its potential – after all, who wouldn’t be?  But from what I’ve seen, the health IT world has paid too little attention to problems that could arise in building out a connected health infrastructure. That’s what makes a recent blog post on connected health problems so interesting.

Phil Baumann, an RN and digital strategist at Telerx, writes that while the concept of connecting things is useful, there’s a virtually endless list of “disconnects” that could lead to problems with connected health. Some examples he cites include:

  • The disconnect between IoT hardware and software
  • The disconnect between IoT software and patches (which, he notes, might not even exist)
  • The disconnect between the Internet’s original purpose and the fast-evolving purposes created in the Connected World
  • The disconnects among communication protocols
  • The disconnect between influencers and reality (which he says is “painfully wide”)
  • The disconnects among IoT manufacturers
  • The disconnects among supply chains and vendors

According to Baumann, businesses that use IoT devices and other connected health technologies may be diving in too quickly, without taking enough time to consider the implications of their decisions. He writes:

Idea generation and deployment of IoT are tasks with enormous ethical, moral, economic, security, health and safety responsibilities. But without considering – deeply, diligently – the disconnects, then the Connected World will be nothing of the sort. It will be a nightmare without morning.

In his piece, Baumann stuck to general tech issues rather than pointing a finger at the healthcare industry specifically. But I’d argue that the points he makes are important for health IT leaders to consider.

For example, it’s interesting to think about vulnerable IoT devices posing a mission-critical security threat to healthcare organizations. To date, as Baumann rightly notes, manufacturers have often fallen way behind in issuing software updates and security patches, leaving patient data exposed. Various organizations – such as the FDA – are attempting to address medical device cybersecurity, but these issues won’t be addressed quickly.

Another item on his disconnect list – that connected health deployment goes far beyond the original design of the Internet – also strikes me as particularly worth taking to heart. While past networking innovations (say, Ethernet) have led to rapid change, the changes brought on by the IoT are sprawling and almost unmanageable under current conditions. We’re seeing chaotic rather than incremental or even disruptive change. And given that we’re dealing with patient lives, rather than, for example, sensors tracking packages, this is a potentially dangerous problem.

I’m not at all suggesting that healthcare leaders should pull the plug on connected health innovations. It seems clear that the benefits that derive from such approaches will outweigh the risks, especially over time. But it does seem like a good idea to stop and think about those risks more carefully.

FDA Weighs In On Medical Device Cybersecurity

Posted on January 5, 2017 I Written By

Anne Zieger is a healthcare journalist who has written about the industry for 30 years. Her work has appeared in all of the leading healthcare industry publications, and she's served as editor in chief of several healthcare B2B sites.

In the past, medical devices lived in a separate world from standard health IT infrastructure, typically housed in a completely separate department. But today, of course, medical device management has become much more of an issue for health IT managers, given the extent to which such devices are being connected to the Internet and exposed to security breaches.

This has not been lost on the FDA, which has been looking at medical device security problems for a long time. And now – some would say “at long last” – the FDA has released final guidance on managing medical device cybersecurity. This follows the release of earlier final guidance on the subject released in October 2014.

While the FDA’s advice is aimed at device manufactures, rather than the health IT managers who read this blog, I think it’s good for HIT leaders to review. (After all, you still end up managing the end product!)

In the guidance, the FDA argues that the best way to bake cybersecurity protections into medical devices is for manufacturers to do so from the outset, through the entire product lifecycle:

Manufacturers should build in cybersecurity controls when they design and develop the device to assure proper device performance in the face of cyber threats, and then they should continuously monitor and address cybersecurity concerns once the device is on the market and being used by patients.

Specifically, the agency is recommending that manufacturers take the following steps:

  • Have a way to monitor and detect cybersecurity vulnerabilities in their devices
  • Know assess and detect the level of risk vulnerabilities pose to patient safety
  • Establish a process for working with cybersecurity researchers and other stakeholders to share information about possible vulnerabilities
  • Issue patches promptly, before they can be exploited

The FDA also deems it of “paramount” importance that manufacturers and stakeholders consider applying core NIST principles for improving critical infrastructure cybersecurity.

All of this sounds good. But considering the immensity of the medical device infrastructure – and the rate of its growth – don’t expect these guidelines to make much of an impact on the device cybersecurity problem.

After all, there are an estimated 10 million to 15 million medical devices in US hospitals today, according to health tech consultant Stephen Grimes, who spoke on biomedical device security at HIMSS ’16. Grimes, a past chair of the HIMSS Medical Device Security Task Force, notes that one 500-bed hospital could have 7,500 devices on board, most of which will be networked. And each networked monitor, infusion pump, ventilator, CT or MRI scanner could be vulnerable to attack.

Bottom line, we’re looking at some scary risks regardless of what manufacturers do next. After all, even if they do a much better job of securing their devices going forward, there’s a gigantic number of existing devices which can be hacked. And we haven’t even gotten into the vulnerabilities that can be exploited among home-based connected devices.

Don’t get me wrong, I’m glad to see the FDA stepping in here. But if you look at the big picture, it’s pretty clear that their guidance is clearly just a small step in a very long and complicated process.

The Required Shift in How Patients View Wearables

Posted on September 27, 2016 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.

This post is sponsored by Samsung Business. All thoughts and opinions are my own.

We’ve all seen the explosive growth that’s occurred in the wearables market. The most extraordinary part of the wearables explosion is that the majority of wearables growth has been in the healthcare space. The problem we now see in healthcare is that most people don’t look at wearables as a disease management tool as much as they see them as lifestyle tools. This was described really well by Megan Williams on the Samsung Insights blog:

Perhaps the most challenging part of meeting that desire [Physician Access to Patients’ Lives and Health] is the fact that patients mostly view wearables as an aid in lifestyle improvement instead of disease management. The task of helping patients understand that wearables are about much more than weight loss will fall squarely on the shoulders of providers.

Patients have traditionally shown a preference for lifestyle apps including fitness, nutrition and heart rate aids, and have been much slower to adopt disease management tools, even as chronic disease remains a burden on healthcare as a whole. Encouraging the use of a broader range of wearables, digital tools and apps will be a challenge for any provider.

Changing habits and perceptions is always a challenge. However, it’s also a great opportunity.

No one would argue that today’s wearables are more than novelty items that may have some impact on your lifestyle (fitness, nutrition, etc). That’s largely because the initial wearables were designed around those retail areas of the market. It’s much easier to create a retail wearable device than to create a disease management focused healthcare device.

As the healthcare wearables market matures so will patients expectations around the benefits they can receive from those wearables. I think there are two main keys to development of wearables as true healthcare devices: Depth of Tracking and Connection to Providers.

Depth of Tracking
I’ve argued for a while now that all the various fitness trackers were not clinically relevant. I still believe that today, but I also believe that wearables like the various fitness trackers will start tracking us in ways that are clinically relevant. That just takes a lot longer to develop.

Whether it’s new trackers that screen for sleep apnea or ECGs that monitor our heart, we’re seeing more and more wearable devices monitoring data that’s more clinically relevant than the number of steps you’ve taken. This trend will continue. As wearables more deeply track various parts of the human body, the opportunities to understand your health and improve your health will follow along with it. This will provide doctors the impetus to request access to your wearable data.

The deep data these wearables will provide will challenge the tried and true beliefs healthcare holds so dearly today. That can be scary for some, but is also very exciting.

Connection to Providers
While wearables will provide the data, we’ll still want to consult a healthcare provider to understand the data and to create a plan of action based on that data. At least in the foreseeable future, our health will depend on collaboration with healthcare providers as opposed to a replacement of healthcare providers. This will be particularly true as the type of data our wearables collect gets more complicated. Understanding your step chart is quite different than understanding your ECG.

In order to facilitate this collaboration, our wearables will have to be connected to our care providers. Note that I said care providers and not doctors. In some cases it might be our doctor, but in other cases it could be a nurse, care manager, social worker, or some other care provider. I’m hopeful that we eventually reach the point of a true care team that collaborates on our health. That’s a far cry from where most of our healthcare is today, but that is the hope.

If we can solve these two wearable challenges: Deeper Data and Connected Providers, then we’ll be well on our way to changing how patients view wearables. This shift won’t happen over night, but I believe it will happen a lot quicker than most people imagine.

For more content like this, follow Samsung on Insights, Twitter, LinkedIn , YouTube and SlideShare.

Virtual Reality in Healthcare

Posted on January 18, 2016 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.

David Chou has an interesting post up over at the Healthcare Standards blog that talks about virtual reality (VR) and where we’ll see it in healthcare. He posits the following 3 areas of healthcare where the healthcare industry can benefit:

  1. Training
  2. Diagnosis
  3. Treatment

I can’t argue with David’s assessment of how virtual reality solutions will be used in healthcare. I think the most promising of these is likely in the medical training area. However, there are no doubt going to be some great treatment options that use VR as well.

The problem with virtual reality in healthcare is that none of the virtual reality companies are going to focus any of their effort on healthcare. Everyone that I talked to at CES (see all our coverage of Digital Health at CES) made it very clear that VR technology was going to start with gaming and video. That opportunity is so large that they don’t have any time or need to go after other markets.

This isn’t to say that virtual reality won’t be used in healthcare. What I’m saying is that virtual reality vendors aren’t going to be doing things to make it easy for healthcare to adopt their technologies. Innovators that want to use virtual reality in healthcare are going to have to take and adapt what’s built for other industries and apply it to healthcare.

Here’s a simple example. I saw an amazing number of 360 degree camera options that are paired with virtual reality. You literally can turn around and see what’s happening all around you as if you were standing in a room. It’s quite amazing technology (although there was some digital stiching that still needs to be improved) and you could see some application of the technology in healthcare. The problem is that it’s unlikely that this video technology is going to be HIPAA compliant by default. Let’s not even talk about these vendors signing a HIPAA business associate agreement.

This example is why I think the medical training aspect of virtual reality is so promising. It’s not governed by HIPAA and so the technology doesn’t have to worry about those requirements and regulations. The same is true for treatment. The problem there is that for it to truly be classified as a treatment, it’s going to have to go through FDA testing and/or clinical trials. The pace of change is moving so fast with virtual reality technology that by the time you finished a clinical trial or became FDA cleared the old virtual reality technology you used will be considered legacy software and hardware.

With all of this said, I had a chance to try out the next generation Oculus Riftat the Dell venue and it was an extraordinary experience. I got lost in the virtual world (I was playing a simple video game) and completely forgot that I was in a noisy bar. I’m excited to see all of the places virtual reality will pop up. That includes in healthcare.

Measuring Patient Discomfort Using Brainwave Activity

Posted on December 30, 2015 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.

Digital health opportunities are popping up everywhere and in every part of the nation. The IoT Journal (Internet of Things) recently profiled a hospital down the street from me who is exploring IoT’s potential to bring drug free relief to patients. Here’s a short excerpt from the article:

Until recently, when health-care providers wanted to gauge the level of discomfort a patient was enduring, they typically had to ask that individual to rate his or her pain—for example, on a scale of 1 to 10—and then use that information to plan treatment accordingly. If they wanted to ease the patient’s pain, they needed to administer medication.

Several months ago AccendoWave released an alternative solution that does not require medication and is personalized to each patient. The system was released in June 2015, says Martha Lawrence, AccendoWave’s founder and CEO, and has since been tested at several facilities. The company has spent seven years researching its solution for assessing patient discomfort levels, and is now using a headband that measures electroencephalography (EEG) activity and prompts a tablet PC to provide content aimed at reducing that discomfort.

The AccendoWave headband, which has seven EEG sensor leads built into it, transmits its brain-wave measurements to the tablet via a Bluetooth connection. The tablet, a Samsung Tab 4, uses its built-in AccendoWave software to process patient brain-wave data and then display diversionary content, including games, music, video clips and full-length movies. If, as a patient views a specific piece of content, the brain waves change to indicate increasing comfort, that content remains on the screen. If the content does not appear to have a positive effect on the brain waves, the software continues to select other content until it displays something appealing to the patient.

Pretty interesting approach. The article does note that they don’t use the brainwave data to determine how much medication to administer. They just use it as a way to assess the system’s effectiveness. They also do patient surveys to assess the impact of the device on a patient’s comfort. The article says that since the hospital implemented the system in the hospital, “1,600 patients have used the device to date, and more than 450 have completed surveys…More than 90 percent of responders reported viewing the system in a positive light.”

I’ve seen these EEG sensors for a while and they’re pretty neat. However, I always wondered how they’d actually be implemented and how they could be used to benefit patient care. No doubt it’s still early in their efforts to use and assess brainwaves, but it’s a pretty interesting solution to tie brain wave activity to soothing images. I’ll be watching to see how this evolves.

Digital Therapies for Healthcare

Posted on December 29, 2015 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 was recently talking to Paulo Machado about what digital health was happening at the CES conference in Las Vegas (see my full schedule of Health Care IT Conferences and Events). Over the 10 years I’ve been going to the event, digital health has really grown at CES. Plus, it has its own subsection called the Digital Health Summit. I’ll actually be speaking at CES as part of a panel on genomics called “Look Who’s Talking: Newborn Genomic Data Enables Precision Medicine” which is happening January 7th, 2:15 PM – 2:40 PM if you’d like to attend.

As I was talking about digital health at CES, I learned that Paulo is now CEO of an evidence based digital therapy company. I’ve long loved the concept of evidence based digital therapies and I was glad to see someone like Paulo working on them. For those not familiar with digital therapies, here’s a look at the top 3 companies in the space:

Claritas Mindsciences
Claritas MindsSciences designs evidence based digital therapies that empower people to manage their cravings and addictions. Dr. Judson Brewer founded the company when he was leading Yale’s Therapeutic Neuroscience Clinic. Our digital solutions deliver evidence-based mindfulness training in a personalized, cost effective & scalable fashion. Our first product, Craving to Quit is a 21 session smoking cessation program based on an NIH funded randomized controlled clinical trials which showed that our approach was twice as effective as gold standard treatment at the end of therapy and was >5x as effective at week 17 with a quit rate of 31%. Healthy Eating and Opioid/Drug addiction solutions will be launched in 2016.

Omada Health
Omada works with employer and health plan customers to provide scalable, effective, and evidence-based behavioral interventions for those at risk for heart disease, diabetes, and other chronic conditions. Combining proven behavioral science and the clinically-meaningful results for a tipping point population – those most at-risk for developing obesity-related chronic diseases. Omada operates on a pay-for-outcomes pricing model that eliminates risk for enterprise customers, and is helping drive the company’s growth in the marketplace.

WellDoc
WellDoc is a digital health technology company that develops mobile solutions to drive behavioral and clinical change in chronic disease. WellDoc’s goal is to improve patient self-management and help physicians overcome gaps in the delivery system to improve clinical outcomes and decrease cost. WellDoc has commercialized the first mobile prescription therapy, BlueStar®, for adults with type 2 diabetes. Mobile prescription therapy fills the support gap between patients and providers during the 8700 hours that individuals are living their lives outside the healthcare system. WellDoc has a proven track record of contributing published, peer-reviewed clinical evidence since 2008 and in June 2015 presented real-world patient engagement and clinical outcomes at the American Diabetes Association’s (ADA) 75th Scientific Session. BlueStar is recognized by the ADA on its website as the first and only in the new class of diabetes treatment known as Mobile Prescription Therapy.

I’m sure there are other companies that are working on digital therapies. Please share them in the comments. It’s time we spend a lot more time learning about these companies since companies like these are going to transform health care as we know it.