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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.

Continue Reading Forecasting the Integration of AI into Health Care Compliance Programs

On March 18, 2024, the U.S. Department of Health and Human Services Office for Civil Rights (OCR) updated its guidance on the “Use of Online Tracking Technologies by HIPAA Covered Entities and Business Associates” (Guidance). OCR’s Guidance was first published on December 1, 2022, and is the subject of a lawsuit brought by…

Below is an excerpt of an article  published in the May 2023 issue of  Health Law Connections, the member magazine of the American Health Law Association. Kate and Conor were assisted on this article by Health Law Group intern Paul Sevigny.

COVID-19 has driven increased telehealth access and technology-based health care services.

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 May 11, 2015. During that time, a cybercriminal obtained access to its IT systems and installed malware that allowed the intruder to obtain access to the protected health information of more than 9.3 million individuals.
Continue Reading Excellus Health Plan Pays $5.1M to OCR in Settlement Following Data Breach

On January 14, 2021, the U.S. Court of Appeals for the Fifth Circuit overturned a $4.348 million penalty for alleged HIPAA violations assessed by the U.S. Department of Health & Human Services (HHS) against the University of Texas M.D. Anderson Cancer Center (Hospital). The case arises from an enforcement action undertaken by HHS following the Hospital’s self-disclosure of three separate instances of lost or stolen portable devices containing electronic protected health information (ePHI). The government’s investigation determined that the devices were not encrypted, and that the Hospital’s failure to encrypt the devices to protect the ePHI contained therein constituted a violation of HIPAA’s Privacy and Security Rules. After HHS imposed the penalty in 2017, the Hospital appealed the penalty first to an Administrative Law Judge, and then to HHS’s Departmental Appeals Board before petitioning the Fifth Circuit for review in 2019 (see our prior analyses of this case here).
Continue Reading Fifth Circuit Overturns “Arbitrary and Capricious” $4.3 Million HIPAA Penalty Against Hospital

Health care providers and contractors continue to be a popular target for hackers. Recently, CHSPSC LLC (CHSPSC), which provides various services to hospitals and clinics indirectly owned by Community Health Systems, Inc. of Tennessee, agreed to pay $2,300,000 to the Office for Civil Rights (OCR) in settlement of potential violations of HIPAA’s Privacy and Security Rules. The OCR investigation and settlement stemmed from a data breach affecting over six million people.
Continue Reading HIPAA Business Associate Pays $2.3 Million Settlement After Hackers Target PHI of Over 6 Million Individuals

These days, news stations are frequently running stories concerning people being treated for COVID-19, the providers working tirelessly to care for them, and politicians visiting health care facilities for a first-hand look at the crisis. In response to the media interest, the Office for Civil Rights (OCR) issued guidance on May 5, 2020 to healthcare providers answering the question “Does the COVID-19 Public Health Emergency alter the HIPAA Privacy Rule’s restrictions on disclosures of protected health information to the media?” The guidance reminds them “that the HIPAA Privacy Rule does not permit them to give media and film crews access to facilities” in which patient health information may be accessible without the patients’ authorization. This includes any areas of the facility where patients’ protected health information (PHI) may be accessible in any form (e.g., written, electronic, oral, or other visual or audio form).

Continue Reading OCR Issues Guidance About Media Access to Health Care Facilities

The Office of Civil Rights (OCR) last month provided guidance and a reminder to HIPAA covered entities and their business associates regarding the sharing of patient health information (PHI) under the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule during an outbreak or emergency situation such as what we are all facing right now with the Novel Coronavirus (2019-nCoV) outbreak.
Continue Reading U.S. Health & Human Services – Office of Civil Rights Issued Guidance Regarding HIPAA Privacy and Novel Coronavirus

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 prescription or to determine drug coverage billing order.

What are E1 transactions and why is this information disturbing?
Continue Reading OIG Audit Finds that Majority of Part D Providers Surveyed Used E1 Transactions for Potentially Inappropriate Purposes

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