U.S. Senators Angus King (I-Maine) and Deb Fischer (R-Neb.), authors of the PROTECT Act (S. 2007), today issued a response to the Administration's FDASIA Health IT Report. In 2012, Congress mandated that the Food and Drug Administration (FDA), in consultation with other agencies, publish a proposed strategy and recommendations on a risk-based regulatory framework for health information technology to be published by January 1, 2014. FDA's draft report, released today, offers guidance on how the federal government intends to proceed to regulate health information technologies, including mobile medical applications. The report assumes continued and undefined authority over regulation of low-risk health information technologies.
"Given the important role health IT is going to play in the future of health care, I'm pleased the FDA has finally presented us with a risk-based regulatory framework for oversight that is similar to the PROTECT Act in many respects," Senator King said. "I am, however, disappointed that the report's recommendations preserve the FDA's authority to change these rules as they see fit, which only further underscores the need for legislative action that will help reassure entrepreneurs in the health IT sector."
"I'm glad to see that the FDA's report, though four months late, agrees with the need for a more risk-based structure as outlined in the PROTECT Act," said Senator Fischer. "However, instead of providing a concrete framework that supports innovation and safety, the report's approach maintains the status quo under which the FDA retains unlimited discretion over regulation of low-risk health IT. As technologies converge, regulatory overlap is becoming more pronounced. That's exactly why Congress must act and codify an appropriate, risk-based framework that provides certainty for health IT."
Under current law, the Food and Drug Administration (FDA) can use its definition of a medical device to assert broad regulatory authority over a wide array of low-risk health IT, including mobile wellness apps, scheduling software, and electronic health records.
In February, King and Fischer introduced the PROTECT Act, legislation that provides clarity to FDA's regulatory process to focus on products that pose a legitimate risk to human health. This more effective, risk-based framework boosts patient safety by prioritizing FDA's attention to technologies that pose the greatest health risk. It also protects low-risk health IT from unnecessary regulatory burdens that stifle opportunities for job creation, innovation, and improved care. U.S. Senator Marco Rubio (R-Fla.) is an original cosponsor of the legislation.
Organizations that support the PROTECT Act include: Application Developer's Alliance, athenahealth, Greenway Health, Health IT Now Coalition, IBM, Information Technology and Innovation Foundation, McKesson, Netsmart Technologies, Newborn Coalition, Pediatric Hydrocephalus Foundation, Software & Information Industry Association, TechFreedom, and Verizon.
Additionally, Nita Farahany, one of President Obama's appointees to the Presidential Commission for the Study of Bioethical Issues, wrote a piece in the Washington Post commending King and Fischer's legislation.