Medical Spa Lawyer
Paddy Deighan, the Premier Medical Spa Lawyer

The U.S. Department of Health and Human Services’ Office of the National Coordinator (ONC) recently provided guidance into the utilization of Artificial Intelligence (AI) in the health industry. Of course it is government agency so the guidance is in a nearly 1,000 page document. The is the first comprehensive U.S. regulation delineating the responsible use and oversight of AI used in connection with health care related matters.  

Artificial Intelligence in healthcare is a contentious topic. Many believe that since AI is in its infancy, and it should be allowed to develop naturally and as outcomes and experience expand, guidance/regulation can follow.

I am known to say, “the law always lags behind technology”. This is natural. However, others believe that the technology of AI is advancing so rapidly that the time to govern (act) is now. There probably is no right or wrong answers as long as the regulation is not too burdensome as to curb technological growth. Nonetheless the ONC states: “we believe now is an opportune time to help optimize the use and improve the quality” of these AI tools.

Beginning next year – January 1, 2025, certain developers of healthcare ITs must meet new transparency requirements.  Those that create and use IT that supports decision-making based either on clinical evidence (this is known as evidence-based decision support) or on algorithms or models trained on data to make predictions, recommendations, evaluations, or analysis (aka Predictive Decision Support Intervention or DSI) will have to provide information about how the IT is designed and developed, the data sets used to train the IT (including, for example, data related to race, ethnicity, sexual orientation, and gender identity), and how the IT is continually evaluated.  Health IT developers of Predictive DSI must perform risk analysis and risk mitigation “related to validity, reliability, robustness, fairness, intelligibility, safety, security, and privacy.”

The close to 1,000 pages do, provide a detailed map of how AI tools can be developed and monitored responsibly.  Developers will be expected to understand and be able to explain how the technology was designed as well as how it works.  

Happy New Year!!!