Insights

Artificial intelligence (AI) is transforming health care, offering ways to improve diagnostics, optimize treatment plans, and enhance patient outcomes. However, its rapid growth raises issues around privacy, safety, bias, and ethics, all of which require regulation. While current frameworks offer some level of oversight, Congress and the Administration have begun exploring new ways to regulate AI, especially in health care. 

Key Areas of Focus for Congressional Regulation 

Data Privacy and Security 

AI systems require massive amounts of health care data to function effectively. Current laws, such as the Health Insurance Portability and Accountability Act (HIPAA), oversee the protection and sharing of medical data. However, HIPAA was not designed with AI in mind. New frameworks may be needed to manage the complexities AI introduces, like the integration of non-traditional data sources and real-time analytics. 

Congress has not passed specific legislation focused on AI data privacy in health care, but there are relevant discussions. Senate Majority Leader Chuck Schumer (D-NY) has taken a leading role in shaping U.S. policy around the use of AI through the formation of bipartisan AI task forces focused on crafting comprehensive legislation to address the rapid advancements in AI, including its implications for health care.  Schumer has expressed concern over the risks associated with AI in health care, particularly regarding patient data privacy, potential algorithmic bias in diagnostic tools, and the need for transparency in AI-driven decision-making. His approach seeks to balance the promise of AI in improving health outcomes with the need for safeguards to protect patients and ensure equitable access to these advancements. 

The House Energy and Commerce Committee, chaired by Rep. Cathy McMorris Rodgers (R-WA), held several hearings focusing on AI in health care. The hearings are part of the Committee’s broader effort to understand and shape the role of emerging technologies in the health sector. The discussions centered on the potential benefits AI could bring to patient care, including improved diagnostic accuracy, faster drug development, and enhanced health care access, particularly in rural and underserved areas. (https://www.maceradrinks.com/)   The hearings also delved into the risks and challenges associated with integrating AI into health care systems. Key concerns discussed included the need for stringent data privacy protections, preventing algorithmic bias that could lead to health care disparities, and ensuring AI tools are transparent and explainable to both patients and providers. 

Safety and Accountability 

Ensuring AI-driven medical technologies are safe is critical. The Food and Drug Administration (FDA) regulates medical devices, including certain AI systems. However, AI presents unique challenges due to its evolving nature, where algorithms may change after initial approval. Current regulations do not always account for this, and Congress may need to create new frameworks to ensure continuous monitoring. 

One such framework may be legislation such as the Artificial Intelligence for the Armed Forces Act which would encourage the use of AI while ensuring safety standards.  While this bill focuses more on defense than health care, Congress could use similar principles to shape legislation addressing health care-specific AI, requiring continuous monitoring and real-time updates to safety regulations. 

An additional approach could be The Advancing American AI Act, which passed the Senate in 2021.  This bill calls for creating government standards for AI across sectors, including health care. Standardization could lead to the development of a more uniform way to evaluate the safety of AI systems in medical settings. 

Bias and Fairness 

AI in health care can perpetuate biases if it is trained on skewed or incomplete data. This is particularly concerning when AI tools are used to diagnose or make treatment decisions, potentially exacerbating disparities in care for marginalized populations. 

On September 24, 2024, Senator Ed Markey (D-MA) introduced legislation to address bias in the use of AI. The Artificial Intelligence Civil Rights Act would prohibit developers from offering or using algorithms that discriminate based on characteristics like race or gender. Additionally, the FDA has acknowledged the issue of bias in AI, proposing guidelines that developers must follow to ensure their algorithms are trained on diverse datasets. Congress may push for legislation that mandates transparency in developing AI health care tools to minimize biases. 

Ethical Standards and Human Oversight 

AI optimizes many aspects of health care, but ethical concerns remain, especially when AI is involved in patient care decisions. AI is already assisting health care professionals in diagnosing diseases, planning treatments, predicting outcomes, and managing population health.  Congress may consider regulations requiring human oversight in critical health care decisions to prevent AI from being the sole decision-maker. Additionally, the need for ethical guidelines to prevent AI from prioritizing efficiency over patient well-being is essential. 

While there is no AI-specific health care legislation addressing ethics, the Biden Administration’s AI Bill of Rights emphasizes the need for meaningful human oversight of AI decisions and proposes guidelines to ensure AI technologies are used ethically. This could lead to future regulations that enforce human oversight in health care AI applications. 

Current Legislative Efforts 

Though Congress has yet to pass comprehensive AI health care-specific legislation, several bills touch on important aspects of AI regulation. One key bill is the National AI Initiative Act of 2020 which would establish a national AI strategy.  While not enacted, the bill lays the groundwork for further sector-specific regulations, including health care. The AI in Government Act of 2020 also would seek to improve AI use across federal agencies and could influence how AI is implemented in federally funded health care programs. 

Conclusion 

AI holds tremendous promise for improving health care but also brings new risks requiring legislation and regulatory oversight. While Congress has yet to enact specific legislation targeting AI in health care, discussions are underway. The focus on data privacy, safety, bias, and ethical standards will likely guide future action. By balancing innovation with patient protection, Congress can shape a health care system where AI enhances care while safeguarding rights and well-being.