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PIH Health, a health care entity located in California, suffered a data breach in June 2019 when 45 employee email accounts were compromised in a targeted phishing campaign. The accounts contained the protected health...more
The Office for Civil Rights (OCR) at the U.S. Department of Health and Human Services has renewed its focus on two critical areas of HIPAA compliance: risk analysis and individual right of access. These enforcement...more
“Almost every stage of modern healthcare relies on stable and secure computer and network technologies.” The above is a direct quote from the Office of Civil Rights for Health & Human Services (“OCR”) in its proposed...more
On May 6, 2024, OCR published the final rule interpreting and implementing Section 1557 at 45 C.F.R. § 92 (the Final Rule). The Final Rule regulates the use of patient care decision support tools, including AI algorithms for...more
As Cyberattacks targeting the health care sector have continued to intensify over the past year, including ransomware attacks that have resulted in major data breaches impacting health care organizations, the protection of...more
Fiduciaries should be aware of recent developments involving AI, including emerging and recent state law changes, increased state and federal government interest in regulating AI, and the role of AI in ERISA litigation. While...more
On January 6, 2025, the U.S. Department of Health and Human Services (“HHS”) Office for Civil Rights (“OCR”) published a Notice of Proposed Rulemaking (“NPRM”) to amend the Health Insurance Portability and Accountability Act...more
2024 was a record year for cyberattacks in the healthcare sector. According to the Breach Portal maintained by the U.S. Department of Health and Human Services (“HHS”) Office of Civil Rights (“OCR”), to date this year, there...more
The HHS Office for Civil Rights (OCR) has abandoned its appeal of a federal judge’s ruling overturning OCR’s guidance prohibiting covered entities (CEs) and business associates (BAs) from using the web-tracking technologies...more
Welcome to Vital Signs, a curated compilation of the latest legal and regulatory developments in digital health. Our lead article reports on HHS' recent final rule on the confidentiality of substance use disorder patient...more
Technology’s exponential development and use in healthcare provides potentially significant benefits for behavioral health patients but also raises ethical and compliance concerns. The most recent technological advance...more
Is your organization a business associate? You could be subject to enforcement action if you fail to protect health information within your control from ransomware attacks. In October, for the first time, the U.S....more
Report on Patient Privacy 23, no. 11 (November, 2023) Tim DiBona clearly remembers Christmas Eve 2018 when the staff of his small firm—Doctors’ Management Service (DMS)—arrived at their West Bridgewater, Mass., office to...more
Report on Patient Privacy 23, no. 10 (October, 2023) By 2016, it should have been clear to HIPAA covered entities that a security risk analysis—and corresponding risk management plan—were compliance basics. Yet, a new...more
In July 2023, the Federal Trade Commission (FTC) and the U.S. Department of Health and Human Services Office of Civil Rights (OCR) sent a joint letter to approximately 130 hospital systems and telehealth providers raising...more
Data governance is a mission-critical issue for every company and institution in the United States. GCs face a host of pressing cybersecurity concerns. Triaging them requires time, attention, and a well-rounded strategy...more
The Department of Health and Human Services (HHS) announced on April 2 that HHS is exercising its enforcement discretion to permit business associates to use and disclose protected health information (PHI) for public health...more
In its January newsletter, the Office for Civil Rights (OCR) focused on cyber extortion, which it stated has “risen steadily over the past couple of years and continue to be a major source of disruption for many...more
In the first settlement for HIPAA violations in 2018, Fresenius Medical Care North America (Fresenius) has agreed to pay $3.5 million to the Office for Civil Rights (OCR) to settle allegations against it relating to five data...more
There is no such thing as compliance with the NIST Cybersecurity Framework (FTC). In September, the FTC dispelled a commonly held misconception regarding the NIST Framework: It “is not, and isn’t intended to be, a standard or...more
In a recent newsletter, the Office for Civil Rights (OCR) encourages health care organizations to review their procedures around authentication and “ensure that they have the appropriate safeguards in place.”...more
A HIPAA violation involving a health plan’s failure to erase protected health information from photocopier hard drives has resulted in a $1.2 million settlement. Your risk can be significantly reduced if you adopt and...more