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

 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

A recently issued government rule may unknowingly create significant liability and legal risk for many technology enterprises. The expanded definition of “business associates” and related interpretations by the Department of Health and Human Services (HHS) suggest that many companies should revisit how they provide services and ask whether they are providing their services to health care providers, health plans, or health care clearing houses (collectively, “covered entities”). HHS seeks to implement the mandates of the Health Information Technology for Economic and Clinical Health Act of 2009 (HITECH Act) by modifying its regulatory scheme (the “HIPAA Rules”) that implements the Health Insurance Portability and Accountability Act of 1996 (HIPAA).1 Two of the most important changes involve “business associates,” defined as entities that perform functions or activities on behalf of covered entities or other business associates that involve the use or disclosure of protected health information (PHI). Among many other changes, the omnibus rule:

  1. expanded the definition of “business associate” and
  2. placed the obligation of HIPAA compliance directly on business associates.

Continue Reading Cloud Storage Providers Storing Protected Health Information May Be Obligated to Comply with HIPAA Regulations