On May 18, 2023, the Federal Trade Commission (FTC) announced a number of proposed amendments to the Health Breach Notification Rule (the Rule), the latest in a series of actions taken by the agency toContinue Reading FTC Announces Proposed Amendments to the Health Breach Notification Rule
On April 12, 2023, the Biden administration announced a notice of proposed rulemaking (NPRM) from the Department of Health and Human Services (HHS) Office for Civil Rights (OCR), the agency responsible for enforcing the Health…Continue Reading HHS Proposes Purpose Limitation on Disclosures of PHI Related to Reproductive Health
On June 29, 2016, the U.S. Department of Health and Human Services (HHS) announced a Resolution Agreement with Catholic Health Care Services of the Archdiocese of Philadelphia (CHCS), settling charges that CHCS failed to comply…
Continue Reading HHS Brings Landmark HIPAA Enforcement Action Against a Business Associate for Alleged Data Security Failures
The U.S. Department of Health and Human Services (HHS) recently issued guidance to help mobile application developers analyze whether the Health Insurance Portability and Accountability Act of 1996 (HIPAA) may apply to them.1 Not every mobile application developer that handles personal health information is subject to HIPAA regulation, and determining whether HIPAA applies is situation-dependent and requires thoughtful analysis. The HHS guidance lists some of the factors to consider when assessing whether HIPAA applies to an app developer and analyzes several scenarios where apps handle health-related information.
Continue Reading HHS Issues HIPAA Guidance for Mobile Health Apps
In late 2015, the U.S. Department of Health and Human Services (HHS) announced three settlements in which the agency will collect over $5 million in collective penalties for alleged non-compliance with the Health Insurance Portability and Accountability Act of 1996 (HIPAA). In addition to the monetary penalties, each of the settlements requires compliance with a Corrective Action Plan (CAP), calling for the organizations to invest significant resources toward HIPAA compliance.
Continue Reading HHS Ends 2015 with Three HIPAA Enforcement Settlements
Following the conclusion of the Health Insurance Portability and Accountability Act (HIPAA) pilot audit program in 2012, speculation began about the timing of the permanent program of periodic HIPAA audits. Originally, the Department of Health and Human Service’s Office of Civil Rights (OCR) scheduled the permanent audit program for 2014. However, personnel and budget limitations delayed the launch, and the year came and went without implementation of the program.
With 2015 nearing its close, advisors in the health data industry may have felt like they were crying wolf while encouraging clients to take this time to review and improve HIPAA compliance efforts given the impending audits. Finally, however, in late September 2015, the OCR announced that the permanent audit program will launch in early 2016. Reports indicate that the OCR has already sent out inquiries to covered entities confirming contact information for possible follow-up.
Continue Reading No More Crying Wolf—HIPAA Audits Coming in 2016
The Department of Health and Humans Services (HHS) Office of the National Coordinator for Health Information Technology (ONC) recently released a practical guide designed to help healthcare providers and their service providers better understand and implement privacy and security protections for electronic health information.1 Organizations that handle personal health-related information, even when they are subject to HIPAA regulation, may find the HHS guide to be a source of information on emerging and better practices. This is updated guidance following HHS’s substantial changes to HIPAA regulations through the omnibus rule in early 2013.
Continue Reading HHS Updates Guide to Protecting Electronic Health Information