This week, Senate Health, Education, Labor and Pensions (HELP) Committee Ranking Member Bill Cassidy (R-LA) released a white paper about artificial intelligence (AI) and its potential impacts on healthcare, education and the workforce. How does HELP’s top Republican predict the future role and influence of AI in the world of healthcare?
The first application covered in the white paper is one of the most obvious: improving drug development and approval. AI is already impacting drug development, with more than 100 drug approval applications in 2021 submitted to the Food and Drug Administration (FDA) that used AI in the development of a given drug. AI has the potential to reduce development costs for manufacturers by up to US$54 billion annually. To take advantage of these benefits, the FDA will need to be able to engage with academia and industry in AI research, as well as employ experts in a wide variety of fields, so that the agency can understand how to regulate AI sensibly. . Additionally, AI can speed up the medication review process. Senator Cassidy notes that Congress will need to explore how to help the FDA recruit and retain top talent, as well as implement AI into the approval process.
The article also discusses the potential role of AI in medical devices, as well as its diagnostic and treatment capabilities. The FDA approved more than 200 AI-enabled medical devices between 2021-2022. As AI technology evolves and its acceptance grows, Congress will need to update the agency approval framework to keep pace. Importantly, the current FDA review process is not designed to incorporate products whose software changes to improve over time. Specific flexibility will be needed to ensure that, whilst consumer safety is maintained, innovation is not stifled unnecessarily.
AI is already being used to help doctors diagnose patients, although questions remain about what this means for doctors’ role in caring for patients. Given that stakeholder trust in AI will be fundamental to its adoption, the document calls for transparency in the development of AI, so that patients and doctors can understand the most appropriate and effective ways to use these tools. This is especially true when it comes to the patient population on which an AI algorithm was trained: a different training population than the actual patient could result in inaccurate usage. The document also calls for a framework that makes liability around harm to patients resulting from the use of AI predictable and clear.
AI will certainly have an immense impact on healthcare administration and insurance coverage as well. Given that administrative tasks, especially around electronic health records, are the biggest cause of physician burnout, AI’s ability to reduce the time spent on these tasks will go a long way toward preventing labor shortages and increasing the quality of patient care. AI could simplify the administrative burdens of healthcare systems, including scheduling and filing of claims, as well as the processing of claims by health insurers. The document notes that some estimates put the national savings in healthcare expenses resulting from the use of AI in administrative functions at 510 percent. The document also notes, however, that Congress will need to ensure that AI algorithms do not replace clinical decisions, a delicate balance to be sure given current debates over the appropriate use of Prior authorization.
Finally, Senator Cassidy’s article notes that Congress will need to address privacy concerns for data used in AI. Some of this data is already covered by the Health Insurance Portability and Accountability Act (HIPAA) privacy rules, but not all. While AI can de-identify the data used in its algorithms, it can also be used to re-identify that data as belonging to a specific individual. The white paper calls on Congress to examine how to protect health information that falls outside the scope of HIPAA. Patient trust in AI systems will be crucial to realizing the benefits of these tools.
AI will continue to play an increasing role in the research and development, clinical and administrative aspects of healthcare. Senator Cassidy’s white paper raises the key questions that any framework must address, as well as crucial questions that policymakers must ask experts and constituents. Congress will need to create specific and flexible policy solutions over the next few years to ensure that AI becomes a boon for health care and not a failure.
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