As the FDA in the U.S. admits the agency cannot keep pace with new technologies in health care, questions are being asked about what it can do to keep pace. In this week’s edition of The GRC Story, Stephanie Baxter looks at what the regulator needs to do to avoid falling behind.
Digital health tools that tap into artificial intelligence and machine learning are revolutionizing health care at a fast pace.
From mobile health to health information technology, wearable devices, telehealth and telemedicine, and personalized medicine, these tools have huge potential to improve the accuracy of diagnosis and treat disease and improve the delivery of health care.
But there are concerns that these solutions are developing more quickly than regulators can regulate them.
The commissioner of the U.S. Food and Drug Administration (FDA) in the U.S. admitted recently that agency cannot keep pace with changes in digital health. Speaking at the National Health Council’s patient engagement symposium, which looked at how to better bring patients into the process of developing and deploying new technologies, commissioner Robert Califf said: “I think we’re behind, and it’s going to be really hard to catch up.”
While his comments have been praised for being realistic and truthful, there are increasing doubts about the FDA’s ability to assure the public that devices are safe to use.
John Giantsidis, president of CyberActa, a boutique consultancy that focuses on medical devices and digital health, points out that this is not the first time the regulator has admitted it is behind the curve on digital health.
He says: “What Commissioner Califf admitted earlier in May of this year, the director of the U.S. FDA’s Center for Devices and Radiological Health (CDRH) forewarned in 2022 when he mentioned “critical regulatory hurdles” if U.S. Congress doesn’t soon update regulatory frameworks for digital health products because the current frameworks [are not] “fit for purpose for modern-day software-based technologies.”
So, why are regulators falling behind on changes in digital health? Are they falling foul of legacy issues? And do they lack expertise and focus?
New technologies are used for a wide range of purposes, from applications in general wellness to applications as a medical device.
They can be used as a medical product, in a medical product, as companion diagnostics, or in conjunction with other medical products such as devices, drugs, and biologics. These technologies can also help to develop or study medical products.
Digital health technologies use computing platforms, connectivity, software, and sensors for health care and related uses.
Giantsidis says the fourth industrial revolution is underway and it will bring digital health under its remit: “All of us, including digital health tools, their creators, and respective regulators, are in the midst of the fourth industrial revolution, which is bringing undeniable opportunities and advances.
“Artificial intelligence is the bedrock of the digital revolution like the steam engine or electricity in the past. AI-based medical systems can be purely software-based, acting in the virtual world, for example, image analysis software, or AI can be embedded in hardware devices, for example, advanced surgical robotics, or Internet of Medical Things applications.”
The FDA and other regulatory bodies are making efforts to ensure they are not left behind in this digital transformation. But given the commissioner’s recent comments admitting the challenges for regulators in keeping up new technologies, what do they need to do to catch up?
Giantsidis is certain that regulators cannot do this alone and that a coordinated plan will be necessary.
“This would require a coordinated plan – in this case a U.S. plan – that would boost the FDA’s technological capacity [and] that would rely on the modernization of education and training systems, nurturing talent, and anticipating changes in the labor market,” he says. “Furthermore, the U.S. would have to create a plan to help all Americans, patients and providers alike, to learn basic digital skills that would further enhance the adoption of automation, robotics, and AI.”
So, what would a fit-for-purpose regulatory framework that can keep up with the revolution in digital health look like?
According to Giantsidis, a fit-for-purpose regulatory framework would entail provisions for three sections – the first being patient safety, cybersecurity, and robustness.q
“All digital health applications should be safe, secure, and robust with carefully managed risks. FDA and other regulatory bodies [like the] FTC ensure that a digital health system is secure throughout its life cycle and regularly tested to ensure its functioning, performance, resilience, and security,” he says.
The second section covers appropriate ‘transparency and explainability’. Digital health systems must provide sufficient information, both inputs and outputs, to be appropriately transparent and able to explain their decision-making processes and risks, Giantsidis says.
Finally, a fit-for-purpose regulatory framework would have provisions for accountability and governance.
“Regulatory measures governing digital health need to sufficiently hold appropriate actors in the digital health life cycle accountable for digital health outcomes. Regulators must ensure clear expectations for regulatory compliance and may need to encourage compliance using governance procedures,” he explains.
As digital health tools that tap into AI and machine learning revolutionize health care at a fast pace, it is essential that regulators like the FDA take necessary actions now to ensure they can keep up with these monumental changes.
