To say it's been a busy few months regarding regulatory actions in the healthcare space would be an understatement. To that end, I don't believe it would be sensationalistic to predict this may be a year in which federal agencies make landmark decisions and establish strategies and historical markers when it comes to mHealth technology oversight.
In fact, one best practice model is already in play and could very well prove to be an approach replicated by other interested entities. The model is the plan ACT - The App Association initiated in the fall of 2014 to draw federal agency attention to outdated and murky regulatory guidance regarding mobile medical software and technology and compliance with the Health Insurance Portability and Accountability Act.
In September, ACT called on lawmakers to help speed innovation and app development for the healthcare sector without sacrificing security and privacy protection, suggesting three specific changes for the U.S. Department of Health and Human Services to make regarding implementation of the Health Insurance Portability and Accountability Act:
- Making existing regulations to be more accessible for tech companies
- Improving and updating guidance from Office of Civil Rights on acceptable implementations
- Ensuring stronger outreach to new entrants in the healthcare industry
In response, Reps. Tom Marino (R-Pa.) and Peter DeFazio (D-Ore.) reached out to HHS Secretary Sylvia Mathews Burwell on the matter, who then responded by calling such outreach efforts "critical." Burwell also said that OCR is exploring a series of "listening sessions" where stakeholders can raise questions and concerns on privacy and security issues.
Those sessions now are being planned for the first quarter of 2015, ACT Executive Director Morgan Reed told FierceMobileHealthcare.
Reed and his group should be applauded for making such inroads in light of the inherent bureaucracy of any federal agency.
Meanwhile, on the compliance front, the Federal Trade Commission should be commended for its approach in handling the case of a software game maker that falsely advertised and marketed a program claiming to make children's brains work smarter and better. The FTC agreed to a settlement on the issue, which reveals that its quest isn't to be punitive or harsh on emerging healthcare-related tech. Rather, the agency appears focused on ensuring that product marketing sticks to proven facts and consumers.
Still, there is one challenge within the world of federal regulations and mHealth technology; the unclear aspect regarding where the FTC steps in and where the FDA steps in when it comes to oversight, whether it be for PC programs or mobile apps. Just prior to the FTC settlement action, the FDA ruled it would not regulate wellness apps designed to boost mental acuity. But it's hard to tell if the two agencies collaborated on their stances, if the FDA gave FTC the green light to be the rule maker, or if the FDA just didn't want to deal with such matters.
What is clear, as health attorney Brad Thompson of Epstein Becker Green, told FierceMobileHealthcare, is the great big overlap in jurisdiction. Thompson said he believes there is a "tactic understanding" in play, and the roles of the two agencies are being shaped as more decisions come into play and regulatory oversight requirements increase.
If that's true--and there are few people as knowledgeable as Thompson on such issues--the slow-and-steady approach by the agencies is a wise one. There is no reason for knee-jerk regulatory decisions or actions, and it seems no one--from the FTC to the App Association--is advocating, or even supportive of making more laws.