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In December 2024, New York Governor Kathy Hochul signed into law two bills (A8872A and S2376B; collectively, the “Bills”) that amend New York’s Data Breach Notification Law.1 The Bills introduce a maximum thirty-day timeframe for notifying affected New York residents of a reportable “breach of the security of the system”2 under

In December 2024, the Assistant Secretary for Technology Policy/Office of the National Coordinator for Health Information Technology (“ASTP/ONC”) within the U.S. Department of Health and Human Services (“HHS”) published two final rules that establish health data interoperability and information blocking regulations (the “New HTI Final Rules”).

The New HTI Final Rules will affect Trusted Exchange

On October 2, 2024, the New York State Department of Health (“NYSDOH”) finalized and adopted new hospital cybersecurity regulations. Effective immediately, hospitals in New York State are required to report to NYSDOH as promptly as possible, but not later than 72 hours after, determining that a cybersecurity incident has occurred. A cybersecurity incident is an

On May 15, 2024, the New York State Department of Health (“NYSDOH”) published revisions to the proposed hospital cybersecurity regulations that it first released in November 2023. Most of the requirements of the initially proposed regulations have been retained in the revised version, subject to a few modifications. The revised proposed regulations are subject to

On March 13, 2024, the U.S. Department of Health and Human Services (“HHS”) Office for Civil Rights (“OCR”) announced that it had opened an investigation into the monumental cyberattack on Change Healthcare (“Change”), a unit of UnitedHealth Group (“UHG”). The attack is one of the largest assaults against the U.S. health care system, with far-reaching

In a Bloomberg Law article, attorneys examined Washington State’s comprehensive new privacy law, the My Health My Data Act, the first state law that specifically safeguards consumer health data.

The article discusses the new law’s scope, applicability, and ensuing company obligations. The Act will apply to many life sciences companies, pharmaceutical and device

On February 28, 2024, President Biden announced an Executive Order directing the Department of Justice to promulgate regulations that restrict or prohibit transactions involving certain bulk sensitive personal data or United States Government-related data and countries of concern or covered persons. The DOJ’s initially identified countries are China (including Hong Kong and Macau), Russia, Iran

On December 20, 2023, the National Institute of Standards and Technology (“NIST”) National Cybersecurity Center of Excellence (“NCCoE”) published its Cybersecurity of Genomic Data report (the “Report”).  The Report aims to assist organizations in protecting against misuse of genomic data and enabling secure collaborative innovations.  Note, however, that the Report is not authoritative with respect to its assessment of the treatment of genomic data under the current U.S. regulatory framework, including with respect to the identifiability of such information.Continue Reading NIST Cybersecurity Center of Excellence – Cybersecurity of Genomic Data Report 

On November 13, 2023, New York Governor Kathy Hochul announced the release of proposed statewide hospital cybersecurity regulations that would require state-licensed hospitals to establish cybersecurity programs, policies and procedures (the “Proposed Regulations”). The Proposed Regulations feature requirements regarding cybersecurity policies and procedures, personnel, user authentication methods, security risk assessments, incident response plans, and two-hour

On July 20, 2023, the U.S. Department of Health and Human Services’ Office for Civil Rights (“OCR”) and the Federal Trade Commission (“FTC”) sent warning letters to approximately 130 hospital systems and telehealth providers. The letters were intended to warn those entities of the privacy and security risks of online tracking technologies integrated into their websites and mobile applications. The agencies noted that the entities may be impermissibly disclosing consumers’ sensitive personal health information to third parties such as Meta/Facebook pixel and Google Analytics through the use of such online tracking technologies in potential violation of the Health Insurance Portability and Accountability Act of 1996 and its implementing regulations, as amended (collectively, “HIPAA”), the FTC Act, and/or the FTC Health Breach Notification Rule (“HBNR”).Continue Reading HHS and FTC Warning Letters Highlight Continued Scrutiny of Use of Online Tracking Technologies in Healthcare