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 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.
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David Lee Scher, MD is Director at DLS HEALTHCARE CONSULTING, LLC, uniquely concentrating in mobile health technology clinical research design and implementation. A former cardiac electrophysiologist, well-respected clinical trial primary investigator, human subject research committee (IRB) chairman, Medicare advisory committee member, Dr. Scher was also a medical device industry key opinion leader for 20 years. He is Board Certified in Internal Medicine, Cardiovascular diseases, and Clinical Cardiac Electrophysiology. A pioneer adopter of remote cardiac monitoring, he lectures worldwide promoting the benefits of mHealth technologies.ufc on fox evans vs davis fast times at ridgemont high fast times at ridgemont high soylent green phil davis george st pierre
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