Health Care Ethical Boundaries in AI: Balancing Innovation with Compliance
By Marisol Cooke
Director, Health Care Consulting Practice
Moss Adams (now Baker Tilly)
Original Publish Date: June 17, 2025
As artificial intelligence (AI) continues to reshape health care, offering predictive analytics, expanded patient engagement, and administrative efficiencies, ethical and compliance frameworks must evolve in parallel.
The promise of faster, data-driven clinical decisions comes with unprecedented ethical challenges that demand robust oversight. Health care organizations must navigate issues related to patient privacy, bias, accountability, and regulatory compliance to deliver AI-driven health care that remains ethical and legally sound.
Ethical Boundaries in AI for Health Care
AI relies heavily on patient data, often collected from electronic health records (EHRs), imaging systems, and wearable devices.
Patient Privacy and Data Security
However, the ethical use of AI requires strict adherence to HIPAA and other privacy laws to prevent unauthorized access, data breaches, or misuse of sensitive patient information.
Key considerations:
- Ensuring AI algorithms de-identify patient data to prevent re-identification.
- Implementing robust cybersecurity protocols to protect AI-driven data exchanges.
- Limiting AI access to minimum necessary data to prevent excessive data collection.
Compliance Challenges in AI-Driven Health Care
AI systems that handle patient health information (PHI) must comply with HIPAA Privacy and Security Rules to prevent data breaches and unauthorized access.
Regulatory Compliance with HIPAA and FDA
Additionally, AI-powered medical devices and software may require FDA approval under the Software as a Medical Device (SaMD) framework.
Steps for remaining compliant:
- Having AI vendors sign Business Associate Agreements (BAA) under HIPAA.
- Performing regular HIPAA risk assessments for AI-driven systems.
- Determining if AI software falls under FDA SaMD regulations and obtaining necessary approvals.
- Embed AI governance into your organization’s compliance charter, with oversight involving IT, clinical, legal, and compliance representatives.
Strategies for Ethical AI Compliance in Health Care
Adopting the following strategies will help AI in health care remain ethical, fair, and legally compliant:
- Develop ethical AI guidelines. Create AI-specific policies covering data privacy, bias mitigation, and transparency.
- Train health care staff on AI ethics and compliance. Educate providers and compliance officers on the risks and best practices for using AI responsibly.
- Audit and monitor. Continuously monitor AI tools for deviation in performance, data or emerging ethical concerns.
We’re Here to Help
To learn more about AI and mitigating risk under regulatory changes, contact your Moss Adams professional.
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