Privacy and Data Security

On November 2, 2023, the American Hospital Association and Texas Hospital Association, in conjunction with the Texas Health Resources and United Regional Health Care System, filed suit against the Secretary of the Department of Health and Human Services (“HHS”) and the Director of the HHS Office for Civil Rights (“OCR”) regarding OCR’s guidance on the use of online tracking technologies by HIPAA entities.[i] This action and its results will impact how healthcare entities must protect and may use certain information collected on their digital sites.Continue Reading Caught in the Web: Hospital Associations Sue OCR on Third-Party Web Tracking Guidance

As more and more states are enacting privacy laws, organizations in the health care industry may be wondering what the impact these laws will have on them. At this point, there are privacy laws in 12 states, with one more (Delaware) likely to be signed by the governor soon. Those laws are in California, Colorado, Connecticut, Florida, Indiana, Iowa, Montana, Oregon, Tennessee, Texas, Utah, and Virginia. (There is also a new law in Delaware currently pending the governor’s signature). Not all are in effect. Only the laws in California, Connecticut, Colorado and Virginia are effective. The others will go into effect between December of this year and 2026, as follows:Continue Reading State Privacy Law Roundup: What Health Care Companies Need to Know

In May, the Federal Trade Commission (“FTC”) proposed changes (the “Proposed Rule”) to the Health Breach Notification Rule (the “Rule”),[1] which, among other items, emphasize that the Rule applies to mobile health applications and related technologies that use or otherwise compile consumers’ health information.[2] While the FTC’s position on this point is not entirely new,[3] industry interpretations of the Rule have been inconsistent.Continue Reading FTC Proposes Changes to Health Breach Notification Rule Clarifying Application to Health and Wellness Apps

Texas is joining a growing number of states in passing comprehensive privacy legislation intended to safeguard consumer personal data.[1] Specifically, the Texas Data Privacy and Security Act (the “Act”) adds protections for consumers[2] and their personal data, which includes any information that is linked or reasonably linkable to an identified or identifiable individual.[3]Continue Reading Texas is Making Moves on a Comprehensive Consumer Privacy Law

Since its launch in November 2022, ChatGPT (“GPT” stands for Generative Pre-trained Transformer), a type of artificial intelligence model, has gained over a million users. ChatGPT is used by entities in a wide variety of industries. On March 1, 2023, OpenAI, the developer of ChatGPT, updated its data usage policies[1] noting that (i) OpenAI will not use data submitted by customers to train or improve its models unless customers expressly opt-in to share such data, and (ii) OpenAI also will enter into business associate agreements in support of applicable customers’ compliance with the Health Insurance Portability and Accountability Act (“HIPAA”).Continue Reading ChatGPT And Healthcare Privacy Risks

Regulatory enforcement and large litigation relating to the use of third party trackers on companies’ websites and applications have been on the rise. Tracking often occurs without the companies’ knowledge or consent. Third party tracking on hospital and provider websites has specifically garnered notable media attention. Recently, there has been significant activity by the Federal Trade Commission (“FTC”) under the Health Breach Notification Rule for unauthorized sharing of personal information. It has begun to penalize and impose steep corrective actions, including long-impacting future restrictions, for such violations.Continue Reading Web Tracking Creates a Web of Data Privacy Risks

On July 1, 2021, the California Department of Public Health (“CDPH”) issued new regulations[1] (the “Regulations”) effective immediately that more narrowly limit the circumstances under which instances of unauthorized access to medical information have to be reported to CDPH.  The new regulations also give CDPH more discretion to adjust penalties for violations.  The Regulations complement Section 1280.15 of the Health and Safety Code (“Section 1280.15”) requiring state-licensed clinics, health facilities, home health agencies, and hospices to prevent any unlawful or unauthorized access to, or use or disclosure of, a patient’s medical information, and to report any unauthorized access, use or disclosure to the Department no later than fifteen (15) business days after the breach was detected.
Continue Reading California Issues New Health Facility Breach Reporting Requirements

On May 6, 2021, the comment period for the proposed modification to regulations implementing the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) Privacy Rule and Health Information Technology for Economic and Clinical Health Act of 2009 (“HITECH”) closed.  The Office for Civil Rights (“OCR”) at the Department of Health and Human Services (“HHS”) issued its initial request for information in December 2018, subsequently released the Notice of Proposed Rulemaking (“NPRM”) to the public on December 10, 2020, and published the Proposed Rule in the Federal Register on January 21, 2021 (the “Proposed Rule”).  After a significant degree of public interest in providing input on the proposals, OCR extended the comment period from its original end date of March 22, 2021 to May 6, 2021.
Continue Reading HIPAA Privacy Rule Modification – Removing Barriers and Promoting Coordinated Care at What Cost?

Virginia is now the second state, after California, to pass a comprehensive privacy law. The Consumer Data Protection Act (“CDPA”) will come into effect January 1, 2023 (the same time as the modification to California’s Consumer Privacy Act (“CCPA”), i.e., the California Privacy Rights Act (“CPRA”)). While CDPA has fairly broad exemptions for entities regulated by other laws, such as HIPAA, there is also a new “opt-in” requirement for collecting “sensitive data.”
Continue Reading What Virginia’s New Privacy Law Means for Organizations in the Healthcare Industry

Will HHS’ approach for imposing penalties in the aftermath of a data breach become a little clearer in 2021? This is a distinct possibility in the wake of a Fifth Circuit decision vacating penalties against MD Anderson Cancer Center. The hospital suffered three data breaches, leading HHS to impose over $4 million in civil penalties. That fine was reversed recently by the Fifth Circuit as arbitrary, capricious, and contrary to law.
Continue Reading What Does the Fifth Circuit’s Vacating of HHS HIPAA Fines Mean for Companies This Year?

On April 2, 2020, the Office for Civil Rights at the U.S. Department of Health and Human Services (“HHS”) announced a Notification of Enforcement Discretion to allow certain uses and disclosures of Protected Health Information (“PHI”) by HIPAA business associates during the COVID-19 public health emergency.  Understanding that the CDC, CMS and state and local health departments need quick access to COVID-19 related healthcare data in order to fight the pandemic, HHS decided to grant HIPAA business associates greater freedom to cooperate and exchange COVID-19-related information with public health and oversight agencies.
Continue Reading HHS Further Relaxes HIPAA Regulations Governing Use and Disclosure of Protected Health Information During the COVID-19 Public Health Emergency