What’s on the Horizon in Healthcare Regarding Artificial Intelligence?

Artificial intelligence (AI) is revolutionizing the field of medicine by enhancing various aspects of the delivery of healthcare services, including diagnosis, treatment planning, drug discovery, patient monitoring, and administrative tasks. AI algorithms can analyze vast amounts of medical data more efficiently and accurately than humans, leading to improved patient outcomes and healthcare efficiency.

While the application of AI to medicine seems to be overwhelmingly positive, there are some concerns about what might happen without oversight. Questions remain about AI’s ability to overcome bias, make fully-informed coverage decisions, avoid HIPAA violations, and more. At both the federal and state levels, there has been a movement to use AI in the medical field while also keeping an eye on using this groundbreaking technology in a responsible way. Here are the most recent developments.

How Is AI Currently Used in Healthcare?

Artificial intelligence appears to have limitless potential in many aspects of society, but perhaps the most groundbreaking is in healthcare. AI has revolutionized everything from how healthcare is delivered to diagnostic measures. It is touted as making healthcare more accurate, saving lives and improving well-being in the process, and filling a gap in the number of providers. 

How is the Horizon of Healthcare Law Changing?

Healthcare law is among the fastest-changing areas of law. This is due to political and policy changes, medical and technological advancements, public health emergencies, and more. The COVID-19 pandemic really brought to light how quickly medical practices can change. AI–and its applications to the medical field–have only amplified the rate at which the law is changing. As AI becomes more prevalent in medicine–and more complications become apparent–there will be legislation or court decisions in response. These legal changes are something that healthcare lawyers will need to remain vigilant of. Both the federal government and individual states are taking notice of the role of AI in medicine. 

Recent Developments in Federal Law

In 2023, there was a flurry of activity at the federal level to address AI. In October of 2023, President Biden announced Executive Order 14110. The executive order does not directly regulate private industry. However, the guidelines will still have a significant impact through their incorporation into federal contracts. Under this order, many agencies will be tasked with issuing standards and guidance for the safe, secure, and trustworthy development and deployment of AI.

Two months later, there was a more direct application to healthcare. The U.S. Department of Health and Human Services’ Office of the National Coordinator (ONC) has recently issued guidance. Buried deep in a rule adoption that was over 900 pages was the first comprehensive regulation in the United States that delineates the responsible use and oversight of AI as applied to decision-making in healthcare. 

Effective January 1, 2025, specific developers of health information technology (IT) certified according to the ONC regulations must comply with additional transparency criteria. Individuals who develop and utilize information technology (IT) that facilitates decision-making processes–whether that is through clinical evidence (i.e. evidence-based decision support) or via algorithms or models trained on data for predictions, recommendations, evaluations, or analyses (i.e. Predictive Decision Support Intervention or DSI)–will be required to furnish details regarding the IT’s design and development, the datasets employed for its training (which may concern race, ethnicity, sexual orientation, and gender identity), and the ongoing evaluation methods employed for the IT. 

Health IT developers of Predictive DSI will be mandated to conduct risk analysis and implement risk mitigation measures regarding aspects such as fairness, intelligibility, reliability, robustness, safety, security, privacy, and validity.

The ONC has outlined a comprehensive roadmap for the responsible development and monitoring of AI tools. Developers will be required to comprehend and articulate the tool’s design and functionality.

Artificial Intelligence in Georgia’s Healthcare Law

Similarly, individual states are grappling with artificial intelligence. In 2023, nearly twenty states introduced legislation regarding artificial intelligence. More than half of those states considered legislation regarding the responsible and safe use of AI in healthcare. Legislators in Georgia are acutely aware of the benefits and risks of AI in medicine and seek to curtail AI’s use in certain applications.

In early 2024, Rep. Mandisha Ann-Marie Thomas introduced House Bill 887 to the Georgia House of Representatives.

It would: 

• Ban AI from making specific insurance coverage determinations. 
• Prohibit the state medical board from utilizing AI for certain healthcare determinations. 
• Cease the utilization of AI to make decisions regarding public assistance.

According to the bill, insurers would be prohibited from relying solely on AI tools for coverage determinations. Instead, any decision proposed by AI must undergo “meaningful review” by a qualified individual capable of overriding the AI’s decision.

The rule aims to regulate AI systems used in healthcare to ensure patient safety, privacy, and effectiveness. It could transform healthcare by advancing AI technology while safeguarding patients’ rights and well-being.

Language in the bill states similar requirements for a clinical setting:

“No actions shall be taken concerning healthcare based solely on results derived from the use or application of artificial intelligence or automated decision tools. Any decision-making process concerning healthcare that resulted from the use or application of artificial intelligence or automated decision tools shall be meaningfully reviewed, in accordance with procedures for such review created by the board, by an individual with authority to override said artificial intelligence or automated decision tools,” states the bill.

The proposed legislation additionally mandates the Georgia Composite Medical Board to establish regulations overseeing AI and enforce disciplinary measures for physicians who fail to adhere to these AI standards.

Contact an Experienced Georgia Healthcare Lawyer

Healthcare law is always on the cutting edge, and AI’s dramatic innovations in the medical field have only increased the speed at which the law in this area is advancing. A good healthcare lawyer not only understands the fundamentals of healthcare law but stays abreast of all legal developments within healthcare. Contact our office today for immediate assistance.

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