Lawyer advocates for ‘holistic’ federal regulations
A healthcare lawyer is urging federal agencies to modernize and harmonize their regulatory approaches as healthcare transitions from individual, discrete products to an era of more connected diagnostic and therapeutic systems.
“We urge FDA to adopt significant, fundamental changes to its approach to keep pace with medicine and technology, and indeed encourage innovation that can do much to enhance the quality of patient care,” wrote Bradley M. Thompson, MBA, JD, Epstein Becker & Green, in an 11-page white paper.
Thompson submitted the paper as his formal response to the Office of the National Coordinator for Health IT’s (ONC’s) May 30 request for comments on elements the FDA and Federal Communications Commission (FCC) should consider as they develop a regulatory framework for health IT.
He cited several new innovations that are driving connections between previous disparate activities, and recommended several FDA regulatory areas in need of modernization. To spur innovation, he advised the FDA to:
- provide clarity and predictability by identifying the types of health IT under its regulatory umbrella;
- engage in more outreach on its regulatory requirements;
- develop a systems approach to regulation that recognizes that each hardware and software component is part of a much bigger interconnected network;
- modernize its rules on off-label promotion to allow for closer collaboration among vendors, clinicians and scientists;
- provide clarification around the investigational device exemption rules and how they apply to common forms of regulated health IT;
- clearly define when incremental improvements trigger premarket requirements;
- modernize its registration and listing requirements to reflect the fact that much software is developed virtually; and
- specify how medical device classification rules are applied in the contact of modularization.
The paper also emphasized the need for more consistency between agencies in their regulatory frameworks. “Having multiple agencies overseeing a particular industry creates a substantial risk of throwing sand in the gears of innovation through duplicative and disjointed regulation. It can be very hard to serve two masters, let alone three,” wrote Thompson.