In addition to concerns such as cost, effectiveness and ROI, healthcare providers who have implemented, or are considering implementing, new AI technologies should be mindful of the myriad legal issues that often come with using AI.
A recent article at the National Law Review provides a list of what legal experts consider the top 10 concerns.
First up, not surprisingly, are an array of Statutory, Regulatory and Common Law Requirements. For example, the authors say, “(d)epending on the functionality that the AI is discharging, there could be state and federal laws that require a healthcare provider or an AI developer to seek licensure, permits and/or other registrations . . . Additionally, as AI functionality expands . . ., the question may be raised as to how these services are regulated, and whether the provision of such services would be considered the unlicensed practice of medicine or in violation of corporate practice of medicine prohibitions.”
Mirroring, in a way, the pure legal concerns are the Ethical Considerations. “Where healthcare decisions have been almost exclusively human in the past,” the authors observe, “the use of AI in the provision of healthcare raises ethical questions relating to accountability, transparency and consent. In the instance where complex, deep-learning algorithm AI is used in the diagnosis of patients, a physician may not be able to fully understand or, even more importantly, explain to his or her patient the basis of their diagnosis. As a result, a patient may be left not understanding the status of their diagnosis or being unsatisfied with the delivery of their diagnosis.”
Closer to what providers have long been familiar with are the Privacy and Security Risks that arise with AI. As the authors point out, “the use and development of AI in healthcare poses unique challenges to companies that have ongoing obligations to safeguard protected health information, personally identifiable information and other sensitive information.” And given that AI requires vast amounts of data, “it is inevitable that using AI may implicate (HIPAA) and state-level privacy and security laws and regulations with respect to such data, which may need to be de-identified.”
Other familiar concerns include Reimbursement Issues and Compliance Program Implications, and while Intellectual Property Considerations may not be a common concern among providers, the authors note that it is particularly important “for AI developers to preserve and protect the intellectual property rights that they may be able to assert over their developments (patent rights, trademark rights, etc.) and for users of AI to understand the rights they have to use the AI they have licensed. It also is important to consider carefully who owns the data that the AI uses to ‘learn’ and the liability associated with such ownership.”
Contractual Exposure, Torts and Private Causes of Action, Antitrust Issues, and Employment and Labor Considerations round out the authors’ list for AI stakeholders to take into consideration.