The U.S. Food and Drug Administration (FDA) recently unveiled a series of guidances about utilizing digital health tools to help patients.
"Patients, their families and their health care professionals are increasingly embracing digital health technologies to inform everyday decisions, from tools that more easily report blood glucose levels to smart watches that can detect atrial fibrillation," the agency said in a press release. "These tools provide patients with a wealth of easily accessible information that can help them make better and more efficient decisions, take steps to improve their lifestyles and health choices, and experience better outcomes.
“We believe that an appropriate regulatory framework that takes into account the realities of how technology advances plays a crucial role in the efficient development of digital health technologies," the FDA continued. "We’ve maintained, since we issued our Digital Health Innovation Action Plan in 2017, that our approach to regulating these novel, swiftly evolving products must foster, not inhibit, innovation."
Raymond J. March, Ph.D., a Research Fellow at the Independent Institute, and Assistant Professor of Economics at North Dakota State University, weighed in on the FDA's statement.
"I'm skeptical," March told the FDA Reporter. "Digital health has been invaluable for advancing health care in the U.S. over the past couple of decades. I think we owe its success to a comparative lack of regulatory oversight. The FDA's recent statement, to me, indicates it wants to strike a balance between additional oversight and maintaining recent advances in innovation and technology. Given the state of oversight currently, this would mean more regulation at the expense of innovation. Given the FDA's history of enacting extremely burdensome regulations, I think the agency is unlikely to reform its regulatory standards without severely restricting patient access to digital health care technology."
March was asked how involved, then, should the FDA be with regard to digital health care moving forward.
"The FDA, as stated in its mission, should determine the safety and effectiveness of drugs and medical devices," March said. "Beyond this, leave regulatory matters to states and to professional organizations. The vast majority of digital technology finds more effective ways to get existing, and approved, medical goods, tests, services, etc., to patients. Further involvement is not striking a balance, it is expanding the agency's regulatory powers.
"I think the FDA's sluggish approach to passing regulation, even where appropriate, within the realm of digital technology shows it is ill-prepared to implement effective regulation," March continued. "I think this is a strong reason to suggest less is more."
March said the market has done a good job in making health care of various levels available to suppliers and consumers.
"Policing should be left at as local a level as possible," he said. "Let the physicians exercise their knowledge of medical care and of their patients. When further oversight is needed, let the states and providers determine proper oversight. I think we can learn a lot from the development of technology broadly over the past 40 years.
"If the FDA must increase oversight in digital health care technologies, I think a streamlined approval process is a must," March added. "Even when it requires the submitting party to pay, adding to regulatory costs, I think the option will be critical to keeping the approval process quick but also effective."
