The Department of Health and Human Services (HHS) has unveiled new regulations for the use of artificial intelligence (AI) in the healthcare sector. In a move aimed at increasing transparency, the agency released the Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency, and Information Sharing rule on December 13th. This comes in response to calls from hospitals and health system executives for a structured framework to guide the ethical advancement and application of AI in healthcare.
As technology advances, the medical community will need to develop standards for these innovative technologies, as well as revisit current regulatory systems on which physicians and patients rely to ensure that healthcare AI is responsible, evidence-based, bias-free, and designed and deployed to promote equity, said Mike Thompson, vice president of enterprise data intelligence at Los Angeles-based Cedars-Sinai.
The new rule is part of a larger effort to address the growing use of AI tools and algorithms in clinical settings. By imposing regulations and promoting transparency, the HHS aims to ensure that healthcare AI is accountable, unbiased, and contributes to equitable healthcare outcomes.
Here are six key things to know about the HHS rule:
1. Healthcare leaders requested guidance: Many hospitals and health system executives had urged organizations like the HHS to create a regulatory framework for AI in healthcare, recognizing the need for standards and oversight to ensure responsible and unbiased use of emerging technologies.
2. Ethical advancement and application: The new rule seeks to provide guidance and regulations that promote the ethical advancement and application of AI within the healthcare sector. It aims to strike a balance between innovation and patient safety, emphasizing evidence-based practices and equitable health outcomes.
3. Ensuring responsible AI: The HHS rule intends to establish clear guidelines for healthcare AI, ensuring that these technologies are responsible and free from biases. By doing so, it aims to enhance patient trust and confidence in the use of AI tools and algorithms in their healthcare journeys.
4. Increasing transparency: Transparency is a key objective of the new rule. The HHS aims to shed light on how AI tools and algorithms are used in clinical settings, enabling healthcare providers and patients to understand the underlying processes and potential impact on their care.
5. Overcoming existing gaps: The HHS acknowledges the need to revisit current regulatory systems to accommodate the complexities of AI in healthcare. By addressing potential gaps in existing regulations, the agency aims to adapt to the evolving technological landscape and ensure effective oversight of AI applications.
6. Promoting equity: The HHS recognizes the importance of fairness and equity in the use of AI in healthcare. The new rule emphasizes the need for AI technologies to be deployed in a manner that avoids exacerbating existing healthcare disparities and promotes equal access to quality care for all patients.
The HHS rules for AI in healthcare mark an important step towards regulating and promoting responsible use of emerging technologies in clinical settings. By establishing transparent guidelines and standards, the agency aims to ensure that AI tools and algorithms contribute to improved patient outcomes and healthcare equity. As healthcare continues to evolve, these regulations will play a crucial role in guiding the ethical advancement and application of AI in the industry.
