“Artificial intelligence technology will play a vital role in the success of value-based care models, and it also promises to improve clinical care, writes attorney Pamela Hepp of Buchanan, Ingersoll & Rooney. However, the adoption of AI in health care raises legal and regulatory issues, including determination of responsibility for poor outcomes, data breaches, and guidelines for licensure and malpractice:
From Scientific American: “Regardless, these clinical applications raise interesting legal questions. For example, if there is an untoward outcome, who is liable—the physician, the manufacturer of the robot under a product liability claim, or both? These machines and devices also store patient data, leading to HIPAA privacy and security concerns in connection with the sharing and storing of such data. On the other hand, artificial intelligence may help health organizations in addressing cyber security by predicting ransomware attacks and other types of unauthorized activity.
Another issue: if a robot is delivering care, how is it regulated? The Food and Drug Administration currently regulates devices, but the practice of medicine is regulated at the state level through licensure by boards of medicine. Will additional licensure or regulatory scrutiny be required if the devices supplant the physician’s practice of medicine? Will such technology become the “standard of care,” such that its use is expected in patient care and the failure to use it could result in malpractice?”