On January 14, 2021, the United States Court of Appeals for the Fifth Circuit vacated a $4.3 million civil monetary penalty that the Office for Civil Rights (“OCR”) of the Department of Health and Human Services (“HHS”) imposed against the University of Texas M.D. Anderson Cancer Center (“M.D. Anderson”). OCR ordered the penalty in 2017 … Continue Reading
On January 5, 2021, an amendment to the Health Information Technology for Economic and Clinical Health (“HITECH”) Act was signed into law. The amendment requires the U.S. Department of Health and Human Services (“HHS”) to “consider certain recognized security practices of covered entities and business associates when making certain determinations” regarding fines, audit results, or … Continue Reading
On December 10, 2020, the Office for Civil Rights (“OCR”) of the U.S. Department of Health and Human Services (“HHS”) issued a proposed rule to modify the Standards for the Privacy of Individually Identifiable Health Information (the “Privacy Rule”) promulgated under the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) and the Health Information … Continue Reading
Throughout September, the Department of Health and Human Services, Office for Civil Rights (“OCR”), announced eight different settlements to resolve a variety of alleged violations of the Privacy and Security Rules promulgated under the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”). Notably, three settlements stem from data breaches in which hackers were able … Continue Reading
In a new post on the Covington Inside Privacy blog, our colleagues discuss the passage of California’s AB 713, a bill that creates a new healthcare-related exemption under the California Consumer Privacy Act of 2018 (“CCPA”) for certain information that has been deidentified in accordance with the Health Insurance Portability and Accountability Act of 1996 … Continue Reading
On September 2, 2020, the U.S. Department of Health and Human Services Office for Civil Rights (“OCR”) announced a new “Health Apps” feature on the HHS.gov website. The new website, which replaces the OCR’s Health App Developer Portal, highlights existing guidance for mobile health (“mHealth”) apps regarding the Health Insurance Portability and Accountability Act (“HIPAA”) … Continue Reading
On July 13, 2020, the U.S. Department of Health and Human Services, Substance Abuse and Mental Health Services Administration (SAMHSA) issued a final rule revising the Confidentiality of Substance Use Disorder Patient Records regulations located at 42 C.F.R. Part 2, commonly referred to as “Part 2.” Under Part 2, federally assisted substance use disorder (SUD) … Continue Reading
On April 9, 2020, U.S. Department of Health and Human Services (“HHS”) issued a Notification of Enforcement Discretion (the “Notification”) regarding certain covered entities and business associates who choose to participate in the operation of a Community-Based Testing Site (“CBTS”) during the COVID-19 nationwide public health emergency. The Notification relaxes HHS’s enforcement of certain provisions … Continue Reading
On April 3, 2020, the Department of Health and Human Services Office for Civil Rights (“OCR”) released an alert warning covered entities and business associates of an individual posing as an OCR Investigator to obtain protected health information. According to the alert, “[t]he individual identifies themselves as an OCR Investigator on the telephone, but does … Continue Reading
On April 2, 2020, the U.S. Department of Health and Human Services (“HHS”) issued a Notification of Enforcement Discretion (the “Notification”) regarding the disclosure of protected health information (“PHI”) to public health authorities and use of PHI to perform analytics for such authorities. Designed to “facilitate uses and disclosures for public health and health oversight … Continue Reading
This month, the U.S. Department of Health and Human Services (“HHS”) issued guidance waiving enforcement of certain provisions of the Health Insurance Portability and Accountability Act (“HIPAA”) in response to the COVID-19 nationwide public health emergency. Covered Health Care Providers On March 17, 2020, the Department of Health and Human Services Office for Civil Rights … Continue Reading
Last week, Senators Amy Klobuchar (D-MN) and Lisa Murkowski (R-AK) introduced the Protecting Personal Health Data Act (S. 1842), which would provide new privacy and security rules from the Department of Health and Human Services (“HHS”) for technologies that collect personal health data, such as wearable fitness trackers, social-media sites focused on health data or … Continue Reading
On April 30, 2019, the Department of Health and Human Services (HHS) published in the Federal Register a notification of enforcement discretion indicating that it will lower the annual Civil Money Penalty (CMP) limits for three of the four penalty tiers in the Health Information Technology for Economic and Clinical Health Act (HITECH Act). The … Continue Reading
On Friday, April 19, 2019, the Office for Civil Rights of the U.S. Department of Health and Human Services (HHS) explained in an FAQ the circumstances under which electronic health record (EHR) systems may be subject to the Health Insurance Portability and Accountability Act of 1996 (HIPAA) liability for an app’s impermissible use or disclosure … Continue Reading
On December 13, 2016, President Obama signed the 21st Century Cures Act (“Cures Act”), Pub. L. 114-255, which aims to expand medical research and expedite the approvals of drug therapies for patients. The Cures Act also contains several provisions related to the HIPAA Privacy and Security Rules. None of these provisions make substantive changes to … Continue Reading
The Department of Health and Human Services (HHS) recently published guidance on HIPAA requirements governing the use of cloud computing entities, specifically cloud services providers (CSPs). In this guidance, HHS explains that CSPs that create, receive, maintain, or transmit protected health information (PHI) on behalf of a covered entity or business associate are considered business … Continue Reading
The Office for Civil Rights (OCR) at the U.S. Department of Health and Human Services (HHS) recently announced a significant settlement with Catholic Health Care Services of the Archdiocese of Philadelphia (CHCS), a business associate under HIPAA, arising from a breach of protected health information (PHI) after the theft of an employee’s iPhone. The iPhone … Continue Reading
Phase 2 HIPAA Audits Underway The HHS Office for Civil Rights (OCR) has begun its effort to audit covered entities and business associates for compliance with HIPAA. We have previously reported on OCR’s preparations for these proactive audits.… Continue Reading
While Americans continue the trend towards replacing the traditional phone call with email and texts, health care providers have yet to catch on when interacting with their patients. A recent survey by Nielsen Strategic Health Perspectives found that less than a third of Americans have access to digital communications with their physicians: The survey found … Continue Reading
Last week, the chairmen and ranking members of the Senate Committee on Health, Education, Labor, and Pensions and the Senate Committee on Finance sent a letter to Andy Slavitt, Acting Administrator for the Centers for Medicare & Medicaid Services (“CMS”), and Jocelyn Samuels, Director of the Health and Human Services (“HHS”) Office for Civil Rights … Continue Reading
A new post on Covington’s Inside Medical Devices blog discusses a new portal recently launched by HHS seeking questions from mobile health application developers. The platform allows for individuals to both submit and review questions on the HIPAA implications of these mobile health applications. To read the post, click here.… Continue Reading
Recent news reports indicate that the Office for Civil Rights (OCR) at the Department of Health and Human Services (HHS) is planning to move ahead with its plan to begin proactive HIPAA audits of business associates and covered entities. In the past, OCR has relied primarily on self-reports of breaches from covered entities (as required … Continue Reading
A recent HIPAA enforcement action highlights the risk of health care providers using unsecured applications to store and share patient data. HHS reached a $218,499 settlement with St. Elizabeth’s Medical Center in Brighton, Massachusetts, a tertiary care hospital that offers both inpatient and outpatient services. The enforcement action followed allegations made to HHS in 2012 … Continue Reading
We recently posted on the Inside Privacy blog about an update to the Guide to Privacy and Security of Electronic Protected Health Information issued by the Office of the National Coordinator for Health Information (ONC). The updated guide incorporates the most current standards in accordance with the new final rules, issued in 2013, under the Health Information … Continue Reading
