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

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

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

HHS recently announced that it will not impose penalties if business associates disclose protected health information relating to COVID-19 during the public health emergency period. This waiver, announced in a Notification of Enforcement Discretion, applies if the disclosure is for public health and health oversight activities. It will apply, the Office for Civil Rights at HHS explained, even if their business associate agreement with covered entities does not specifically allow for such disclosure if two things hold true. First, that the disclosure or use is made in “good faith” for public health activities and health oversight activities.  Second, that the BA informs the covered entity within ten days after the use or disclosure occurs.  Examples provided by HHS include BA notifications to public health authorities, such as the CDC, health departments and CMS.
Continue Reading HHS Relaxes Restrictions on Certain PHI Disclosures During COVID-19 Public Health Emergency

Following its 20th plenary session on April 7, the European Data Protection Board (EDPB) selected geolocation and health data to focus on in its upcoming COVID-19 guidance. This follows in response to the EDPB’s earlier broad statement on the processing of personal data in the context of COVID-19.
Continue Reading EDPB Announces Scope of COVID-19 Guidance