The U.S. Food and Drug Administration's regulatory framework is outdated, health attorney Brad Thompson said in a letter to the Office of the National Coordinator for Health IT this week. He suggests several changes that will help to "address the unique aspects of health IT."
Thompson, who works for law firm Epstein Becker Green and serves as general counsel for the mHealth Regulatory Coalition, an industry group that focuses on mHealth regulatory and policy issues, also says the FDA and ONC, along with the Federal Communications Commission, need to be more "holistic" in their guidance to avoid confusion, duplication and regulatory conflict. His letter and an accompanying white paper serve as a response to a request for "broad input" published in the Federal Register in May by the three organizations on what elements should be considered for a risk-based regulatory framework to be proposed for health IT.
"Having multiple agencies overseeing a particular industry creates a substantial risk of throwing sand in the gears of innovation through duplicative and disjointed regulation," Thompson and his colleagues says in the white paper. "It can be very hard to serve two masters, let alone three."
Thompson and his colleagues say that, in the case of e-health, the government's intentions were never to have multiple agencies regulating product development. However, they say, technology convergence means that the FDA, ONC and FCC all now oftentimes regulate the same products.
The white paper identifies a total of 10 FDA regulatory areas in need of an update. A few of those areas include:
- The need for investors to ID both cost and timeliness associated with developing products
- The development and design of hardware and software components to be used as parts of systems
- Collaboration among all quarters in the development of e-health technologies, including relationships between vendors and customers
- Practical ways to test low-risk components in real world settings (such as through the release of beta software programs)
- Frequent adoption of incremental improvements to software and hardware
"Innovation and patient well-being are complementary, not competing, policy objectives," Thompson and his colleagues say. "We believe that updating the current FDA regulatory system to address the unique characteristics of e-health is necessary. Such modernization will encourage the innovation needed to advance healthcare and ensure that patients will receive the benefits of some incredible breakthroughs in a timely way."