It’s no secret that scientific and technological innovation is accelerating at breakneck speed, and nowhere is the evidence stronger than in the biomedical technology sector. When, by whom, and how will these innovations and their descendants be monitored, regulated, and tested for safety and efficacy?

Federal agencies such as the FDA, CMS, and the Federal Trade Commission have traditionally played a pivotal role in the evaluation of drugs and medical technologies. Assessing analytical validity, clinical validity, and clinical utility limits the number of new entrants to the market and ensures the quality of new products.

The rapidly evolving nature of today’s biomedical technology, coupled with the sheer volume of new products, creates serious gaps in regulatory oversight.

The burgeoning field of genetic testing is a prime example. Once confined to scientific laboratories and academia, genetic tests are now being developed commercially and sold to the public for a wide range of purposes, including clinical diagnostics, law enforcement, and immigration. Most of these genetic tests are unregulated, raising concerns about their marketing without independent analysis to verify the seller’s claims.

Current trends in the manufacturing and marketing of biomedical devices have raised concerns as well. Consider that laymen are now building biomedical technology devices and selling them directly to consumers for a variety of uses. FDA-cleared devices designed to affect the activity of .) are manufactured online and sold in assembly kit form!

A recent article by Mathews and colleagues explains how and why we got to this point and, importantly, reinventing the governance of biomedical technology in a way that takes into account the changing technological landscape. It presents a thoughtful approach to configuration.

The authors focus on two important underlying issues:

The existing governance structure is designed for research and development with a focus on safety. The development and use of new biomedical technologies raises not only fundamental moral and ethical questions (e.g., human brain intervention and genome modification), but also “dignity, civic responsibility, beneficence, and other raises concerns about human values. Many current governance mechanisms do not take these principles and values ​​into consideration.

Current governance models assume that technology remains within the remit of individual regulatory bodies. We recognize that the complexity of current biomedical technology development and deployment makes governance by a single entity impossible.

Clearly, the pace of technological evolution calls for a more holistic approach to governance that spans multiple sectors, applications and stakeholders. The trend in governance is toward a coordinated approach in which diverse experts from different disciplines and multiple sectors collectively evaluate new medical scientific advances and technologies in the context of their potential impact on society. We are starting to migrate.

The new biomedical technology governance framework described by Mathews and colleagues is intended to be applied across different axes (e.g., affordability, access, and Allows for evaluation along the sharing of benefits and harms). The American Academy of Medicine’s Committee on Emerging Science, Technology and Innovation (CESTI) in Health and Medicine now provides a platform for multi-stakeholder perspectives on various aspects of emerging technologies. Board members drawn from a variety of academic disciplines, professional backgrounds and sectors are developing a comprehensive framework to help rebuild the governance ecosystem. Lessons learned over the past two years are useful for developing a cross-cutting governance framework that addresses existing inequities and facilitates the rapid translation of principles of health and medical innovation into meaningful policy choices. help.

Why is there an urgent need for a regulatory policy restart? In other words, they are hampered early in the development of new technologies. As technology becomes “highly pervasive” and its harmful effects become apparent, it becomes much more difficult, and sometimes too late, to act.

Even if I’m late at the start gate, my feeling is that it’s not too late yet.