Authors: Meena Datta, Deeona Gaskin, Elizabeth Hardcastle, Maarten Meulenbelt, Josefine Sommer, Chen Yang, Tatjana Sachse, Zina Chatzidimitriadou, and Eva Von Mühlenen
Digital health technologies are currently being deployed in areas as diverse as diagnostics, medical imaging, therapeutics, and patient monitoring. The success of the digital health and medical AI industries, and the use of these technologies by pharmaceutical and device companies to support innovation in drug and device development, depends on the successful navigation of the evolving regulatory opportunities and burdens in the U.S., the EU, UK, and China.
In the U.S. alone, there are close to 200 AI and machine learning devices with marketing authorization., having come onto the market via various pathways, including the 510(k) clearance process, a de novo request, or a premarket approval application. FDA’s Digital Health Center of Excellence is prioritizing new guidance for 2023 and offering enhanced opportunities for stakeholder involvement, including in collaborative communities focused on digital health measurement, pathology, and ophthalmic imaging.
These digital technologies show great promise, but they also raise issues that continue to be a focus for regulators, and for which companies should stay aware of and work to address. First and foremost, FDA requires that any products that fall under the medical device definition perform as intended and to be of high quality. Bias remains a concern for the development of algorithms that may be trained with data sets that may not include relevantly diverse participants.
Expect increased scrutiny on cybersecurity as regulators continue to focus on mitigating risks stemming from unauthorized access and misuse. FDA’s Center for Devices and Radiological Health (CDRH) plans to prioritize the finalization of further cybersecurity guidance in 2023. Similarly, the European Commission (the Commission) has proposed measures for a high common level of cybersecurity across the EU to increase the safety of interconnected medical devices and the Internet of Things.
The core reimbursement challenges in 2023 for digital health and medical AI technologies with diagnostic or therapeutic uses include obtaining medical coding for insurance claims and securing appropriate coverage and reimbursement. Many digital health and medical AI technologies do not fit neatly into the existing benefit categories and reimbursement pathways in the U.S. and the EU. Unfortunately, many payors and regulators have outdated coverage and reimbursement structures that create commercialization roadblocks for digital health and medical AI companies. Too often, payors and regulators rely on existing regulatory frameworks for drugs, devices, and physician services to evaluate coverage and reimbursement for digital health and medical AI products. In 2023, it will therefore be imperative for diagnostic and therapeutic digital health and medical AI companies that plan to commercialize in the U.S. and the EU to develop early strategies to support coverage and reimbursement.
In the EU, the first-ever legal framework on AI is likely to come into force in 2023. This is expected to classify AI applications according to “risk levels” and will also suggest comprehensive restrictions for high-risk AI systems. The new AI Act will be accompanied by new AI product liability rules. In order to address the new requirements and associated risks, life sciences companies will need to update and upgrade their risk governance structures and their networks of contracts with suppliers, customers, consumers, and insurers.
In the UK, new evidence standards frameworks for digital health and AI are under development by the national authority. Regulators are also currently exploring an early value assessment pathway for digital technologies. The aim is that this pathway would enable interim recommendations on reimbursement to be accepted while further evidence is generated. The UK has said that it intends to take a light approach to AI regulation in order to remain agile, developing sector-specific guidance where required.
In China, the rapid growth in digital health is attracting a great deal of attention from the regulators. However, like the U.S. and EU, China continues to use its existing regulatory frameworks to evaluate digital health innovation (specifically, the frameworks for medical services and medical products). In 2023, it will therefore be critical for companies looking to commercialize digital health and medical AI products in China to work within the existing frameworks, while monitoring for regulatory developments that the Chinese government may consider to target and facilitate the expansion of digital health and medical AI.
All stakeholders pursuing digital health or medical AI products would be well advised to monitor activity at the WHO. The WHO launched its Global Strategy on Digital Health 2020-2025 that guides national regulators in their approach to virtual care, remote monitoring, AI, big data analytics, blockchain, smart wearables, and tools for (remote) data capture, exchange, and storage. The WHO is expected to issue additional, more targeted guidelines in these areas in 2023. Guidelines issued by the WHO often become a blueprint for national legislation. Stakeholders are thus advised to monitor developments at the WHO to be prepared for additional corresponding national regulations and to consider engaging constructively with the WHO early on.
Meena Datta, Elizabeth Hardcastle, and Deeona Gaskin explain why digital health technologies continue to face challenges with coding and securing appropriate coverage and reimbursement, despite FDA’s prioritization of digital health guidance, and provide tips for moving forward in the current environment.
Maarten Meulenbelt, Tatjana Sachse, Josefine Sommer, Zina Chatzidimitriadou, and Eva von Mühlenen look at key trends in data sharing, structural embedding of digital tech, cybersecurity, and reimbursement for digital health tech, and examine the current overhaul of the UK system.