Adoption of mHealth: Can we see the Forest through the Trees?


In previous posts, I have highlighted many drivers and stakeholders (patient advocates, healthcare providers, insurers, hospitals, Pharma, and others) as key to the success of the adoption of digital health technologies (. There was a recently proposed amendment to the MDUFA (Medical Device User Fee Act) which places a moratorium on the publication of the FDA’s guidance on the use of mobile medical apps. The mHealth coalition responded with a letter to Senator Harkin, the Chairman of the Committee on Health, Education, Welfare, and Pensions, urging the publication of the guidance document. The bill was passed by the Senate and is expected to pass the House vote. I have expressed my reasons for which I believe that medical apps require FDA oversight. Does the FDA think this is going to fix itself or wish that the industry just go away?

I believe that this action will result in mHealth technologies gaining more footing via consumer tools and apps than on patient, transition, and outpatient monitoring and management ones. While the engagement of people in wellness is not a bad thing, the biggest impact of these technologies is the potential for improvement of healthcare delivery. Development of creative innovation will be slowed and driven overseas. It leaves hospitals and providers with possibly less secure ways of utilizing apps, while paradoxically having the government overregulate the industry until guidelines are furnished.

So the forest is the vision of how mHealth technology and other digital technologies can disrupt in a meaningful way the healthcare system. The trees are the regulatory, reimbursement, and some legal/security issues. Politicians need the help of clinicians and not just telecom companies and others in the industry to convey how important this issue is. They respond to personal stories which hit home and remind them that they too are patients and caregivers. Burying heads in the sand is not going to cut it regarding this issue. Rulings and guidelines need to be rolled out. Politics and amendments should have no place in such important issues regarding the FDA.

About these ads

About davidleescher

David Lee Scher, MD is Director at DLS HEALTHCARE CONSULTING, LLC, which specializes in helping digital health technology companies, their partners and clients. As a former cardiac electrophysiologist and pioneer adopter of remote patient monitoring, he is uniquely qualified to address both clinical and operational concerns of clients. Scher was Chair of Happtique's Blue Ribbon Panel which established standards for certification of medical apps in the categories of safety, operability, privacy, and content. He is a well-respected expert in mobile and other digital health technologies and lectures worldwide on technology and its impact on patients and healthcare systems.
This entry was posted in digital health, Election 2012, FDA, health insurance, Healthcare IT, healthcare reform, media coverage, medical apps, medical devices, mHealth, mobile health, pharma, politics, technology, wireless health and tagged , , , , , , , , , , . Bookmark the permalink.

Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out / Change )

Twitter picture

You are commenting using your Twitter account. Log Out / Change )

Facebook photo

You are commenting using your Facebook account. Log Out / Change )

Google+ photo

You are commenting using your Google+ account. Log Out / Change )

Connecting to %s