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February 16, 2026, is the deadline for each HIPAA covered entity to update its Notice of Privacy Practices (NPP) to incorporate new regulatory requirements enacted in 2024. Specifically, HIPAA-covered entities (including health care providers and health plans) are required to review and revise their NPPs as necessary to ensure compliance with a 2024 federal rulemaking…

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

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

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

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

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 in Illinois, acted as a business associate under HIPAA.

OCR initiated an investigation in February, 2015, after receiving an anonymous complaint concerning medical records that had been discovered and delivered to a facility for shredding and recycling. OCR’s investigation indicated that Filefax impermissibly disclosed PHI of 2,150 individuals over a two week span in early 2015 by leaving PHI in an unlocked truck in Filefax’s parking lot, or by leaving PHI within medical records sitting outside of Filefax’s business for a third party to collect.
Continue Reading Dumpster Diving Leads to $100,000 Fine for Defunct Business Associate Due to Improper Disposal of Medical Records

On December 28, 2017, the Centers for Medicare and Medicaid Services (CMS) published a memo to state survey agency directors clarifying its position on the use of text messaging among health care providers. In its memo, CMS stated that it does not permit texting of patient orders by health care providers, as texting of patient…