California’s governor recently signed SB 41 into law. The bill enacts the Genetic Information Privacy Act (GIPA). The governor rejected a similar bill last year over concerns about COVID-19 public health efforts. To address that concern, this bill exempts tests used to diagnose whether an individual has a specific disease.
Continue Reading California Enacts New Privacy Law for Genetic Data
The use of apps, wearables, and other devices used to track health and wellness data have continued to rise. The FTC again signaled its focus on this growing industry in a statement on the scope of the Health Breach Notification Rule. In the statement, the FTC called out specific types of apps and trackers that it views as having notification obligations under this rule.
Continue Reading FTC Warns Digital Health Industry to Comply with its Breach Notification Rule
Recently, the National Institute of Standards and Technology (NIST) requested comments to its Resource Guide for implementing the HIPAA Security Rule. (i.e., SP 800-66). This Guide, first released in 2008, summarizes the HIPAA Security Rule standards and explains the structure and organization of the Security Rule.
Continue Reading NIST Plans to Update HIPAA Security Guidance – Asks for Comments
Utah’s governor recently signed into law SB 227, creating the Genetic Information Privacy Act (GIPA). The law, which is anticipated to go into effect in May, is aimed at protecting genetic data collected from direct-to-consumer genetic testing companies. Generally, the law creates requirements for (i) notice; (ii) consent for certain data uses; (iii) data security obligations; and (iv) access, deletion, and destruction rights.
Continue Reading States Continue to Step in to Safeguard Genetic Information
The new acting FTC chair, Rebecca Kelly Slaughter, recently signaled that the FTC may increase enforcement and penalties in the privacy and data security realm. Slaughter pointed to several areas of focus for the FTC this year, which companies will want to keep in mind:
Continue Reading What Is FTC’s Course Under Biden?
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?
The HHS Office for Civil Rights released, at the end of last year, findings from audits it conducted in 2016 and 2017 of 166 covered entities and 41 business associates. The report represents the periodic audit that the Department of Health and Human Services must periodically conduct of covered entities and business associates for compliance with the requirements of HIPAA and the HITECH Privacy, Security, and Breach Notification Rules. There are many practical take-aways for businesses from the OCR’s report.
Continue Reading Learning from the Mistakes of Others: OCR Releases Audit Report
Governor Gavin Newsom of California vetoed a bill that would have created new limitations on data sharing for direct-to-consumer genetic testing companies.
Continue Reading California Governor Pulls the Plug on Genetic Information Privacy Act
An amendment to the CCPA recently passed through the legislature, adding some much needed clarity to HIPAA-regulated entities, research institutions and other life science and medical device companies. CCPA in its current form left open uncertainty for business associates, de-identified information, and information collected in the course of medical research. AB 713 helps clarify certain exemptions and applicability of CCPA to organizations in the health and research space.
Continue Reading CCPA Amendment Adds Needed Clarity for Medical & Research Community
The EDPB recently issued guidelines about how to use health data during the current pandemic in compliance with GDPR. Given the COVID-19 pandemic, there have been many research efforts in place to fight against the virus. The EDPB’s guidelines shed light on the special rules for processing health data for scientific research, which apply in the context of the COVID-19 pandemic:
Continue Reading Using Health Data in Europe During COVID-19