New Section 1557 Final Rule: What Healthcare Providers Need to Know About AI and Patient Care Decision Support Tools
The healthcare landscape is evolving rapidly, and wiht it, the regulatory framework governing the use of technology in patient care. On May 6, 2024, the Office for Civil Rights (OCR) published the final rule interpreting and implementing Section 1557 of the Affordable Care Act (ACA). This rule, codified at 45 C.F.R. § 92, introduces stringent requirements for the use of patient care decision support tools, including AI algorithms, in healthcare operations.
the Final Rule applies to a wide range of tools used for screening, risk prediction, diagnosis, prognosis, clinical decision-making, treatment planning, and resource allocation. On January 10, 2025, OCR released a “Dear Colleagues” letter, providing additional guidance on how covered entities—such as recipients of federal financial assistance, the U.S. Department of Health and Human Services (HHS), and entities established under Title I of the ACA—can comply with these new requirements.
What Are Patient Care Decision Support Tools?
Table of Contents
- New Regulations Require Healthcare Entities to Mitigate AI Discrimination Risks in Patient Care
- New Regulations Require Healthcare Entities to Mitigate AI Discrimination Risks in Patient Care
- Editor’s Questions and Guest’s Answers
- Q: What are the key requirements for healthcare providers under the Section 1557 Final Rule regarding AI tools?
- Q: how does the OCR evaluate compliance with these new regulations?
- Q: What are the implications of using race as an input variable in AI tools compared to age?
- Q: What are the legal and practical implications of these new regulations?
- Editor’s Questions and Guest’s Answers
According to the Final Rule, patient care decision support tools are defined as “any automated or non-automated tool, mechanism, method, technology, or combination thereof used by a covered entity to support clinical decision-making in its health programs or activities.” this includes AI algorithms used in diagnosis, treatment, patient monitoring, and other aspects of healthcare operations.
Key Requirements for Covered Entities
The Final Rule imposes two critical obligations on covered entities:
- Identification of Risk: Covered entities must make “reasonable efforts” to identify uses of patient care decision support tools that employ input variables or factors measuring race, color, national origin, sex, age, or disability. The January 10 letter provides examples of how entities can meet this requirement, such as:
– Reviewing OCR’s discussion of risks in the Section 1557 final rule, including tools used to assess risks of heart failure, cancer, lung function, and blood oxygen levels.
– Researching published articles in peer-reviewed medical journals or materials from healthcare professional associations.
– Utilizing or creating AI registries developed by non-profit organizations or internal registries to track tool usage.
– Obtaining data from vendors about the input variables used in their tools.
- Mitigation of Discrimination: Covered entities must ensure that their use of these tools does not result in discrimination. OCR will evaluate compliance on a case-by-case basis, considering factors such as:
- The entity’s size and resources (e.g., larger hospitals with IT departments are expected to make greater efforts).
– The available information at the time of tool use.
– Whether the tool was used as intended by the developer or customized by the entity.
– Whether the entity received information from the developer about potential discriminatory risks.
Table: Key Requirements Under the Section 1557 Final Rule
| Requirement | Details |
|——————————-|————————————————————————————————-|
| Identification of Risk | Covered entities must identify tools using input variables tied to protected characteristics. |
| Mitigation of Discrimination | Entities must ensure tools do not discriminate based on race, sex, age, disability, etc. |
| Compliance Evaluation | OCR will assess compliance based on entity size, available information, and tool usage. |
What Does This Mean for healthcare Providers?
For healthcare providers, the Final Rule underscores the importance of openness and accountability in the use of AI-driven tools.As OCR emphasizes, “covered entities have an ongoing duty to make reasonable efforts” to identify and mitigate risks associated with these tools.
Providers must also stay informed about the latest research and guidance from HHS and other regulatory bodies. The January 10 letter highlights the need for collaboration with vendors and the use of AI registries to ensure compliance.
Looking Ahead
The Section 1557 Final Rule represents a meaningful step toward ensuring that AI and other decision support tools are used ethically and equitably in healthcare. As OCR continues to refine its guidance, covered entities must remain vigilant in their efforts to comply with these new requirements.
For more information, healthcare providers can refer to the OCR’s dear Colleagues letter and the Section 1557 final rule.
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This article is based exclusively on the provided source material. For further details, visit the OCR’s official guidance and the Section 1557 final rule.
New Regulations Require Healthcare Entities to Mitigate AI Discrimination Risks in Patient Care
The U.S. Department of Health and Human Services (HHS) has introduced stringent requirements for healthcare entities to address potential discrimination risks posed by artificial intelligence (AI) tools used in patient care. Under the Final Rule of section 1557 of the Affordable Care Act, covered entities must now take “reasonable efforts” to identify and mitigate risks of discrimination tied to AI-driven decision support tools.These regulations, which aim to ensure equitable healthcare delivery, will take effect on May 1, 2025, following the general prohibition on discrimination that began on July 5, 2024.
The Growing Role of AI in Healthcare
AI tools are increasingly being integrated into healthcare systems to assist with clinical decision-making, diagnostics, and treatment planning. However, these tools are not immune to bias, particularly when input variables like race, age, or disability are involved. The Office for Civil Rights (OCR) has emphasized that tools using race as an input variable may face greater scrutiny compared to those using age, which frequently enough has a clinical and evidence-based purpose.
As an inevitable result, healthcare entities must now adopt robust methodologies to evaluate and mitigate potential biases in AI tools. This includes establishing written policies, monitoring impacts, and ensuring a “human in the loop” review process to override potentially discriminatory decisions.
Key Requirements for Mitigating discrimination Risks
The Final Rule outlines specific steps covered entities must take to mitigate risks:
- establish Governance Measures: Develop written policies and procedures for the use of AI tools in decision-making.
- Monitor and Address Complaints: create mechanisms to address complaints of alleged discrimination and monitor the real-world performance of AI tools.
- Maintain AI Registries: Use internal or external AI registries to track tools and ensure compliance with regulatory standards.
- Train Staff: Educate staff on how to interpret and report decisions made by AI tools, including factors required by federal rules.
- Audit Tool Performance: regularly audit AI tools in real-world scenarios to identify and address discriminatory outcomes.
- Disclose AI Use: Inform patients when AI tools posing a risk of discrimination are used in their care.
| Key Mitigation Strategies | Description |
|——————————-|—————–|
| Governance Policies | Written procedures for AI tool usage |
| Complaint Mechanisms | Systems to address discrimination complaints |
| AI Registries | Tracking tools for compliance and oversight |
| Staff Training | Educating staff on AI decision interpretation |
| Performance Audits | Real-world testing to identify biases |
| Patient Disclosure | Informing patients about AI tool usage |
Scrutiny of Input Variables
The OCR has highlighted that AI tools using race as an input variable may require additional mitigation efforts compared to those using age. This is because race-based inputs are more likely to perpetuate systemic biases, whereas age-based inputs often serve a clinical purpose.For example, an AI tool predicting patient outcomes based on age might potentially be less controversial than one using race, which could inadvertently reinforce existing disparities.
Legal and Practical implications
The Final Rule’s requirements come amid ongoing legal challenges. A nationwide injunction currently stays enforcement of portions of the rule prohibiting sex discrimination based on gender identity, as seen in the case of Tennessee v. Becerra. Though, the broader mandate to mitigate AI-related discrimination risks remains intact.
Healthcare entities must now balance innovation with equity, ensuring that AI tools enhance care without exacerbating disparities.As Alexandra P. Moylan,a health law expert at Baker Donelson,notes,”The stakes are high for healthcare providers to get this right. Failure to comply could result in significant legal and reputational risks.”
Looking Ahead
As the healthcare industry continues to embrace AI, the focus on mitigating discrimination risks will only intensify. Covered entities must act swiftly to implement the necessary policies and procedures to comply with the Final Rule by the May 2025 deadline.
For further insights or assistance, healthcare providers can reach out to experts like Alisa L. Chestler, Samuel Cottle, or Michael J. Halaiko at Baker Donelson’s Health Law team.
The integration of AI in healthcare holds immense promise, but it also demands vigilance to ensure that these tools serve all patients equitably. By addressing potential biases head-on, healthcare entities can harness the power of AI while upholding their commitment to fairness and inclusivity.
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New Regulations Require Healthcare Entities to Mitigate AI Discrimination Risks in Patient Care
Editor’s Questions and Guest’s Answers
Q: What are the key requirements for healthcare providers under the Section 1557 Final Rule regarding AI tools?
A: The Section 1557 Final rule mandates that healthcare providers take “reasonable efforts” to identify and mitigate risks of discrimination tied to AI-driven decision support tools.This includes establishing governance measures, such as written policies and procedures for AI tool usage, and creating mechanisms to address complaints of alleged discrimination. Providers must also maintain AI registries to track tools, train staff on interpreting AI decisions, regularly audit tool performance, and disclose AI use to patients when there’s a risk of discrimination.
Q: how does the OCR evaluate compliance with these new regulations?
A: The Office for Civil Rights (OCR) will assess compliance based on several factors, including the size of the entity, the facts available, and how the AI tools are used. The OCR emphasizes that covered entities have an ongoing duty to make reasonable efforts to mitigate risks, and compliance will be evaluated through these lenses.
Q: What are the implications of using race as an input variable in AI tools compared to age?
A: The OCR has highlighted that AI tools using race as an input variable may require additional mitigation efforts compared to those using age. This is as race-based inputs are more likely to perpetuate systemic biases,whereas age-based inputs frequently enough serve a clinical purpose. For example, an AI tool predicting patient outcomes based on age might be less controversial than one using race, which could inadvertently reinforce existing disparities.
Q: What are the legal and practical implications of these new regulations?
A: The Final Rule’s requirements come amid ongoing legal challenges, such as the nationwide injunction staying enforcement of portions of the rule prohibiting sex discrimination based on
