A group of 58 companies sent a letter to Congress requesting that the FDA implements a “risk based” framework for deciding when and how health IT companies should be regulated.
The group argues that current FDA framework is outdated, causing a lot of uncertainty in the marketplace.In April, the Obama administration sent a document called the FDASIA Health IT Report to Congress, and the tech companies are now looking to have those recommendations codified into law before the end of the current Congressional session.
The group argues that current FDA framework is outdated, causing a lot of uncertainty in the marketplace. “We are concerned that there is significant confusion in the market about what technologies may be regulated, by which agencies, and to what standards,” the letter reads. “This uncertainty creates barriers to the development of promising technologies that can help clinicians access more evidence-based medicine, provide patient populations with specific needs more individualized care, and generate better patient-caregiver-provider engagement.”
The idea is to divide various digital solutions into three categories, each with different risk levels, and appropriate regulatory approach. The first group would include technologies that present little risk to patients; the second group consists of diagnostic or solutions that present some other significant potential risk to patients, and these should require close FDA oversight. Finally, the third category would encompass the remainder of health IT that may pose some risk, and should be subject to risk-based oversight that uses consensus standards and private certification bodies to verify that these technologies function safely and well.
“There is broad consensus on the need for a risk-based framework for health IT,” the letter reads. “Members of Congress on a bipartisan, bicameral basis, along with other government officials, including the FDA, together with industry, care providers, patient advocates, and other healthcare stakeholders have agreed publicly on the core components of appropriate regulation of health IT.”
The idea is to divide various digital solutions into three categories, each with different risk levels, and appropriate regulatory approach.However, the federal agencies did not make recommendations in April, and have instead floated a draft of recommendations for comment. One of those comments is against dividing health technologies into three neat categories, arguing that health IT is being woven together in a very complex web of software, and it is “utterly impossible to divide that into three discrete groups.” Instead, they propose a regulatory strategy that acknowledges the network, and the fact that software and hardware is all becoming interconnected.
Few another points of confusions include the difference between wellness and disease, the scope of medical device accessories, and the portion of clinical decision support software the agency regulates.
These and other answers are still expected to be answered and eventually integrated into a law. In the meantime, here’s the full list of companies that signed a letter to the Congress:
Alliance for Aging Research
American Association of Diabetes Educators
Brain Injury Association of America
Center for Data Innovation
Health IT Now
Ingenious Med, Inc.
Institute for eHealth Policy
International Essential Tremor Foundation
LGBT Tech Partnership
National Alliance on Mental Illness
National Association of Manufacturers
National Council for Behavioral Health
National Retail Federation
NTCA-The Rural Broadband Association
Parent Project Muscular Dystrophy
Pediatric Hydrocephalus Foundation
Pharmacy HIT Collaborative
Sarcoma Foundation of America
The Latino Coalition
Trice Imaging, Inc.
U.S. Chamber of Commerce
UltraLinq Healthcare Solutions Inc.
United Spinal Association
US Oncology Network