The changing nature of the regulatory environment for clinical AI presents unique challenges for leaders in the healthcare sector. As healthcare systems look to adopt and implement AI responsibly, a range of regulatory compliance issues have come to the fore, bringing with them the need for effective internal governance structures. The application of AI in its more advanced form is already making its mark in patient workflows that were not envisaged during its initial stages of adoption, and this is having a noticeable impact across various healthcare service lines.
This progress has given rise to critical discussions surrounding the fresh challenges in the regulation and governance of clinical AI. As part of an Aidoc-hosted webinar, experts shared their insights into this evolving aspect of healthcare.
A key factor underlined in the discussions is the necessity for a multidisciplinary approach. Regulations can be extremely complex and collectively might run into thousands of pages. It would be an unreasonable expectation for a healthcare system to keep abreast of so much information on its own. Karen Mandelbaum, Senior Counsel at Epstein Becker Green P.C, advocates the formation of a coalition of experts across the healthcare organizations to handle this mammoth task.
These experts are crucial in aiding others to navigate the complex regulatory environment. According to Shilpa Patel, Managing Director for Innovation & Product Strategy at the American College of Cardiology, understanding the growing presence and potential advantages of AI in patient care delivery is vital. It is through expertise like Patel’s that professional healthcare groups guide their members in determining the use of AI. In addition, Mandelbaum highlights the lessons that can be learned from HIPAA compliance when planning the future of AI.
An interesting angle explored during these discussions is the ‘human’ aspect of AI. Bill Fera, MD, Principal at Deloitte Consulting LLP, points out the somewhat paradoxical assertion that AI will, in fact, help healthcare regain its human touch. By automating repetitive tasks, healthcare professionals can free up time for direct patient care and interaction. This emphasizes the significant role of AI in healthcare, not as a replacement for human presence but as an enhancement of it.
Overall, these expert perspectives provide a valuable exploration into the changing regulatory landscape for clinical AI and highlight the importance of a collaborative, multidisciplinary approach. They also underscore the potential benefits of AI in healthcare, and importantly, the humanistic aspect it brings along with it. As these discussions continue to evolve, they will undoubtedly shape the future of AI in healthcare.
