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In August, the Office for Civil Rights (OCR) published guidance relating to individuals’ rights to access their protected health information (PHI) under HIPAA. As we covered in our earlier blog post about the August guidance, the new FAQs came amidst OCR’s continued enforcement focus on its Right of Access initiative, under which the OCR has…

*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

This week, the Department of Homeland Security’s inspector general said in an oversight report that U.S. Customs and Border Protection (CBP) officials have failed to use adequate cybersecurity measures and safeguards to protect travelers’ data. The report says that from July 2017 to December 2019, personal data was left vulnerable to hackers in the Mobile…

The Centers for Medicare and Medicaid Services (CMS) requested an audit by the Office of Inspector General (OIG) of Medicare Part D eligibility verification transactions (E1) transactions. The OIG recently released its report which found that the majority of the providers evaluated used E1 transactions for some inappropriate purpose other than to bill for a…

Everyone knows how I feel about those home genetic testing kits—most people don’t understand that when they send their DNA to a private company that it is not protected by HIPAA or any other law, and the company can legally use and disclose it, including selling it to other companies. Understand what companies are doing…

On June 3, 2019, the U.S. Department of Health and Human Services Office of Inspector General (OIG) issued a fraud alert to notify consumers about genetic testing fraud schemes (the Alert). According to the OIG, fraudulent actors are using the provision of free genetic testing kits to obtain Medicare information from unwitting consumers, and…

There was unfortunately some bleak news out of the Department of Health & Human Services, (HHS) Office of the Inspector General (OIG) recently. The OIG recently released the results of a performance audit of the HHS’ compliance with the Federal Information Security Modernization Act of 2014 (FISMA). The OIG Report states that FISMA requires that…

Last week, a new audit report was released regarding the Federal Aviation Administration’s (FAA) unmanned aircraft system (UAS or drone) waiver process. According to the audit, the Office of the Inspector General (OIG) has found room for improvement. In particular, the FAA’s timeliness in response to waiver requests could improve.

The audit was conducted between…

The Office of Inspector General (OIG) recently announced the creation of a cybersecurity team focused on combating threats within the Department of Health & Human Services (HHS), and within the health care industry. The team includes auditors, evaluators, investigators, and attorneys with experience in cybersecurity matters, and its work is intended to build on the cybersecurity priorities the OIG has previously identified in its annual assessments and reports.
Continue Reading OIG Announces New Multidisciplinary Cybersecurity Team