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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.

Mobile App Reimbursement

Posted on July 3, 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.

It’s only been a question of time for when insurance companies would start reimbursing companies for a mobile health application. In an article on Forbes, they talk about WellDoc being the First to Sell Mobile Prescription Therapy. The company WellDoc has gotten FDA clearance for their mobile application BlueStar.

WellDoc has started to sale BlueStar through self-insured companies, but will now have to get out there and work with doctors much like drug companies have to do. The next generation of pharma sales reps are going to be peddling mobile applications to doctors.

The key to what WellDoc is doing is their year-long randomized clinical trial to prove that its product works and doesn’t cause side effects. The question I have is how many mobile health applications are planning to go to this effort.

I was a little disappointed to find out that WellDoc’s mobile application does require a mobile coach as well. So, the mobile is an important part of the product, but they still have a human participating as well. Certainly they’re treading lightly in this new form of mobile therapy.

I love this quote from the Forbes article:

All this was new territory for pharmacies and the National Council for Prescription Drug Programs which maintains standards for exchanging pharmacy data. “Their reaction was ‘you’re like a drug, but you’re not; you’re like a device, but you’re not,’” says Bergstrom. “They realized this is where the future is going,” adds Anand Iyer, WellDoc’s president.

No doubt there’s going to be a lot of challenges that WellDoc faces as it tries to sale doctors on using this product. However, they’re right that it is the future.

BlueStar By WellDoc To Be First Mobile Prescription Therapy

Posted on June 19, 2013 I Written By

Katie Clark is originally from Colorado and currently lives in Utah with her husband and son. She writes primarily for Smart Phone Health Care, but contributes to several Health Care Scene blogs, including EMR Thoughts, EMR and EHR, and EMR and HIPAA. She enjoys learning about Health IT and mHealth, and finding ways to improve her own health along the way.

You may be familiar with WellDoc already. They are distributors of a mobile app that was created to help manage diabetes, which has been very successful. And just a few days ago, they released something else that appears to be rather monumental.

The service is called BlueStar, and is the mobile version of the diabetes management program. What’s so monumental about this, is that it is the first disease therapy to be prescribed through an app. In addition to that, it is also the first that can be eligible for reimbursement through insurance. Not all insurance companies will cover it, but self-insured companies like Ford, Rite Aid, and DexCom have said BlueStar will become a part of their pharmacy coverage.

BlueStar features many of the same features that Diabetes Manager, the first WellDoc program, did which include getting alerts when their blood sugar level is too low or high and charts to detect trends. It suggests tips for getting blood sugar higher. However, what’s new is that BlueStar can provide feedback concerning medication dosage, give better coaching, and even recommendations to a doctor.

Just like any prescription, a doctor can prescibe BlueStar for a certain period of time in addition to medications. When a pharmacy receives that prescription, they will forward it on to WellDoc, who will have someone help the patient setup BlueStar on their device. BlueStar will calculate how much insulin a patient should take, depending on the attending physician’s recommendations, blood sugar levels, and how many carbs were eaten at a certain time. If a treatment regimen is deemed to be ineffective for a patient, a report will be sent to the doctor recommendation a new regimen.

Because diabetes truly affects so many across the country, this could mean a lot to many people. Of course, there are questions about how effective it can be, since many people may become unmotivated after using the app for a certain period of time. Time will only tell.

Lessons Learned from FDA Cleared Mobile Health Devices

Posted on May 6, 2011 I Written By

Like so many other things the government may start making life more difficult for mHealth companies in the future through regulations.  It really does not surprise me as they like to stick their nose in everything, but there are a few different perspectives at this point.  There is a great article by Brian Dolan at mobihealthnews.com about FDA Cleared Mobile Health Devices.  I have included a few interesting parts of the article below.  It is clear that the FDA will change their involvement the question is now what impact they will have.

“We need to balance our desire for safety with rational risk tolerance and transparency,” the West Wireless Health Institute’s Chief Medical Officer Dr. Joseph Smith said during his presentation at the Institute’s Health Care Innovation day in Washington, DC last week. “And I think — I’ve not shared this with them — but I think we need to get the FDA out of the business of assuring absolute safety and into one of absolutely assuring transparency around risks and making sure decisions are well-informed as opposed to trying to protect all of us from the rare circumstances of failed technology.”At the event FDA officials confirmed that a draft guidance document focused on how the agency might regulate health apps would likely publish in the coming months. Officials acknowledged that apps included just a small sliver of the activity going on in mobile health, but it is a start. The FDA will seek commentary on the draft document from the industry during a 60 or 90 day period, officials said.

“Our intent was to support both patients and healthcare providers in the management of chronic disease,” Sysko said. “As we looked at the regulations as early as 2005 of the software that the FDA had published, it was really clear to us that we were an accessory to a medical device — an accessory to a blood glucose meter… We thought that there were sufficient guidelines from a software perspective to go ahead. Little did we know that it would be a long journey and there were many bumps along the way — many self-inflicted — but we felt that it was absolutely something we would have to do to bring our product to market.”