It’s no secret that technological innovation has been accelerating at an astonishing rate, and the evidence is most evident in the field of biomedical technology. How, when and by whom are these innovations and their descendants monitored, regulated and reviewed to ensure safety and efficacy?
Traditionally, federal agencies such as the FDA, CMS, and the Federal Trade Commission have played a key role in evaluating pharmaceuticals and medical technologies. By evaluating analytical validity, clinical validity and clinical utility, the number of new entrants to the market is limited and the quality of new products is ensured.
The rapid development of biomedical technology today, coupled with the sheer volume of new products, has led to some serious loopholes in regulatory oversight.
The emerging field of genetic testing is a case in point. Genetic tests once limited to scientific labs and academia are now being developed commercially and sold to the public for a wide range of uses—clinical diagnostics, law enforcement and immigration, to name a few. Most of these genetic tests are not regulated, and there are growing concerns about their marketing in the absence of any independent analysis to verify sellers’ claims.
Current trends in the manufacture and marketing of biomedical devices are also of concern. Consider that laymen are now building biomedical technology devices and selling them directly to consumers for a variety of applications. For example, there are transcranial neurostimulators (FDA-approved devices designed to affect brain activity using magnetic fields) that are manufactured and sold online in self-assembled kits!
A recent article by Mathews and colleagues describes how and why we have come to this juncture and, more importantly, proposes a thoughtful approach to re-architecting biomedical technology in a way that takes into account the changing technological landscape Governance.
The authors focus on two key underlying issues:
The existing governance structure is designed for research and development with a focus on security. The development and use of emerging biomedical technologies raises fundamental moral and ethical issues (eg, interfering with the human brain or modifying the genome) as well as “concerns related to dignity, civic responsibility, charity and other human values”. Many of our current governance mechanisms do not take these principles and values into account.
The current governance model assumes that technology will remain within the purview of a single regulator. We now recognize that the current complexity of biomedical technology development and dissemination precludes the governance of a single entity.
Clearly, the speed at which technology evolves requires a more holistic approach to governance—one that spans multiple departments, applications, and stakeholders. Trends in governance are beginning to shift towards a coordinated approach, in which different experts from multiple disciplines and sectors work together to evaluate emerging medical scientific advances and technologies based on their potential impact on society.
The new biomedical technology governance framework described by Mathews and colleagues allows for the development of technologies and their uses along a range of axes (e.g., affordability, accessibility, and benefits and harms) at specific points in time and over time. assignments) are assessed. The National Academy of Medicine’s Council on Emerging Science, Technology, and Innovation (CESTI) in health and medicine now provides a platform for diverse stakeholder perspectives on all aspects of emerging technologies. Committee members from diverse disciplines, professional backgrounds and sectors are developing a comprehensive framework to help reshape the governance ecosystem. Lessons from the past 2 years will help develop cross-sectoral governance frameworks to address existing inequalities and facilitate the rapid translation of health and medical innovation principles into meaningful policy choices.
Why do we need to restart regulatory policy? To paraphrase the authors’ repeated interpretation of the methodological premise known as the “Collingridge’s Dilemma,” policymaking is hampered in the early stages of new technology development due to uncertainty and a lack of sufficient evidence of its impact. Once the technology is “highly diffused” and its harmful effects become apparent, it becomes more difficult to act – and in some cases, too late.
My feeling is that even though we’re slow in the beginning, it’s not too late.