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*This post was co-authored by Josh Yoo, legal intern at Robinson+Cole. Josh is not admitted to practice law.

Health care entities maintain compliance programs in order to comply with the myriad, changing laws and regulations that apply to the health care industry. Although laws and regulations specific to the use of artificial intelligence (AI) are limited at this time and in the early stages of development, current law and pending legislation offer a forecast of standards that may become applicable to AI. Health care entities may want to begin to monitor the evolving guidance applicable to AI and start to integrate AI standards into their compliance programs in order to manage and minimize this emerging area of legal risk.

Executive Branch: Executive Order on the Safe, Secure, and Trustworthy Development and Use of Artificial Intelligence

Following Executive Order 13960 and the Blueprint for an AI Bill of Rights, Executive Order No. 14110 (EO) amplifies the current key principles and directives that will guide federal agency oversight of AI. While still largely aspirational, these principles have already begun to reshape regulatory obligations for health care entities. For example, the Department of Health and Human Services (HHS) has established an AI Task Force to regulate AI in accordance with the EO’s principles by 2025. Health care entities would be well-served to monitor federal priorities and begin to formally integrate AI standards into their corporate compliance plans.

  • Transparency: The principle of transparency refers to an AI user’s ability to understand the technology’s uses, processes, and risks. Health care entities will likely be expected to understand how their AI tools collect, process, and predict data. The EO envisions labelling requirements that will flag AI-generated content for consumers as well.
  • Governance: Governance applies to an organization’s control over deployed AI tools. Internal mechanical controls, such as evaluations, policies, and institutions, may ensure continuous control throughout the AI’s life cycle. The EO also emphasizes the importance of human oversight. Responsibility for AI implementation, review, and maintenance can be clearly identified and assigned to appropriate employees and specialists.
  • Non-Discrimination: AI must also abide by standards that protect against unlawful discrimination. For example, the HHS AI Task force will be responsible for ensuring that health care entities continuously monitor and mitigate algorithmic processes that could contribute to discriminatory outcomes. It will be important to permit internal and external stakeholders to have access to equitable participation in the development and use of AI.

National Institute of Standards and Technology: Risk Management Framework

The National Institute of Standards and Technology (NIST) published a Risk Management Framework for AI (RMF) in 2023. Similar to the EO, the RMF outlines broad goals (i.e., Govern, Map, Measure, and Manage) to help organizations address and manage the risks of AI tools and systems. A supplementary NIST “Playbook”  provides actionable recommendations that implement EO principles to assist organizations to proactively mitigate legal risk under future laws and regulations. For example, a health care organization may uphold AI governance and non-discrimination by deploying a diverse, AI-trained compliance team.Continue Reading Forecasting the Integration of AI into Health Care Compliance Programs

On March 18, the Office for Civil Rights of the U.S. Department of Health and Human Services issued a Bulletin updating its guidance to HIPAA-covered entities and business associates on the use of tracking technology on websites and mobile apps.

The Bulletin supplements the original guidance published by OCR in December 2022.

According to the…

On May 17, 2023, the U.S. Department of Health and Human Services’ Office for Civil Rights (OCR) announced a settlement with MedEvolve, Inc. for $350,000. MedEvolve provides practice and revenue cycle management and practice analytics software services to health care entities. The settlement resulted from MedEvolve’s alleged violation of the Health Insurance Portability and Accountability…

The U.S. Department of Health and Human Services Office for Civil Rights (OCR) recently announced that it had entered into a Resolution Agreement, Corrective Action Plan, and settlement with Lifetime Healthcare, Inc., the parent of Excellus Health Plan, over alleged violations of HIPAA relating to a data breach that occurred from December 23, 2013 through…

It is clear that the health care industry continues to be targeted with cyber-attacks. In 2018, the 10 largest health care breaches, outlined here, include unauthorized access to protected health information (PHI) through a vendor offering claims processing, ransomware incidents, successful phishing schemes, mailing PHI to wrong addressees, hacking, a misdirected email, and a…

Verizon recently issued its Protected Health Information (PHI) Data Breach Report, which is always an interesting read. Not surprisingly, Verizon’s report concludes that based upon analysis of 1,360 security incidents involving the health care sector, 58 percent of the incidents were caused by insiders and 42 percent were caused by external threats.

Insider threats can…

On February 13, 2018, the HHS Office for Civil Rights (OCR) announced a $100,000 settlement with a court-appointed receiver representing Filefax, Inc. (Filefax) arising from the 2015 discovery of medical records that contained protected health information (PHI) of over two thousand individuals in a dumpster. Filefax, a now-defunct medical records moving and storage company located…

ABCD Pediatrics, located in San Antonio, Texas has notified the Office for Civil Rights that a ransomware cyber intrusion has resulted in access to its servers, including the protected health information (PHI) of its patients. The ransomware used by the attackers was Dharma. The practice found through forensic analysis that access had been gained to…

Whenever fact sheets or other guidance is issued by either the Office of the National Coordinator for Health Information Technology (ONC) or the Office for Civil Rights (OCR), it helps gain insight into the thinking of the regulators so we watch it closely.

But when the ONC and OCR issues joint guidance, it is hitting the jackpot.
Continue Reading ONC and OCR Issue Joint Fact Sheet on Use of PHI for Public Health Activities

On January 7, 2015, HHS issued new guidance (Guidance) regarding an individual’s right to access his or her health information under HIPAA’s Privacy Rule. The Guidance emphasizes that HIPAA, while protecting the privacy and confidentiality of individuals’ health information, also recognizes the importance of providing individuals with access to their health information.

The Guidance reviews…