The European Commission (EC) has proposed updates to rules regarding product liability, one of which is an update to strict liability policy for pharmaceuticals (and presumably medical devices) that would expand the term of liability to 15 years. The proposal for artificial intelligence (AI) liability would up the ante on transparency into these algorithms, and the combination of the two novel policies would suggest that life science companies may face a more uniform, but potentially more hazardous legal landscape in the EU should these proposals be adopted.
The U.S. Congress has reauthorized several user fee programs at the FDA, and the agency has published the user fee levels for several product types, with most of those fees increasing significantly, an example of which is the increase for new drug applications (NDAs) requiring clinical data from $3.12 million to $3.24 million. Fees for medical device premarket approval (PMA) filings will jump from $375,000 to $442,000, including some hefty adjustments for persistent inflation, a problem that may plague the user fee schedules for fiscal 2024 as well.
The U.S. FDA’s device center recently advised companies that make tests for the COVID-19 pandemic that the emergency use authorization program for tests is winding down, albeit with a few exceptions.
The U.S. FBI is not typically seen as playing a meaningful role in medical device cybersecurity, but the agency recently released a report regarding unpatched and outdated medical devices, nonetheless. The report includes five recommendations to deal with these devices, but the agency gives no indication as to whether the report signals an interest in enforcement activities related to medical device cybersecurity.
The Biden administration has released a blueprint for an artificial intelligence bill of rights, which is accompanied by an acknowledgement that these algorithms can be crucial in guiding treatment of cancer patients.
The U.S. FDA’s finalized guidance for clinical decision support (CDS) software was not an entirely isolated policy change inasmuch as there were several other guidances that were edited and reissued two days after the CDS final was published. One of these is the guidance for device software functions and mobile medical apps, which now encodes a transparency requirement as seen in the CDS guidance, a change that may represent a hazard for the unwary medical software developer.
The U.K. Medicines and Health Care Products Regulatory Agency (MHRA) announced recently that it is considering an increase in the fees it levies on industry for a variety of services and actions, such as premarket applications. One of these is a 10% indexation increase in all statutory fees, but there are also some proposed increases in cost recovery charges and an additional 22 new fees for cost recovery that would be new to applicants seeking access to the U.K. market.
The most conspicuous part of the data problem for artificial intelligence (AI) medical software is the bias problem, but the U.S. Government Accountability Office (GAO) says there are policy solutions despite the data ownership/monetization problem.
The U.S. Congress has finally managed to pass legislation that reauthorizes several FDA user fee programs, but the final vote came on the last day of the federal fiscal year and addressed a stripped-down version of previous user fee bills. While several key considerations survived the shift to a lean bill, the FDA will have to wait for another day to be authorized to regulate lab-developed tests and to revise the accelerated approval program for pharmaceuticals, measures that may be revisited before the end of the current calendar year.
In a development that is a potential boon for wearables and other sectors of the digital health industry, the U.K.’s NICE has petitioned the National Health Service (NHS) to expand its coverage of devices that monitor patients with Parkinson’s disease. That data would be used by NICE to inform a health technology assessment that might ultimately boost sales of these devices if the data suggest a strong benefit to patients and to the U.K. health care budget.
