The Department of Health and Human Services (HHS) announced a Request for Information (RFI) regarding how the HIPAA Privacy, Security, and Breach Notification Rules could be modified to reduce regulatory burdens and to improve care coordination, case management, and value-based health care. In addition to opening the door for public comments on current challenges and potential modifications to the HIPAA Rules, the RFI specifically requests feedback on anticipated changes to several specific provisions of the Privacy Rule.
Representatives from government and the private sector discussed the present state of healthcare cybersecurity, and experts discussed practical strategies for implementing the HIPAA Security Rule at the ninth annual “Safeguarding Health Information: Building Assurance through HIPAA Security” conference held from October 19–20, 2016 and co-hosted by the National Institute of Standards and Technology and the Department of Health and Human Services, Office for Civil Rights. Comprehensive, enterprise-wide risk analysis and risk management practices remained points of emphasis throughout the conference. Additional themes, which we outline in this post, also emerged.
On Wednesday, August 17, 2016, the Future of Privacy Forum released a set of detailed guidelines for the collection and use of consumer-generated wellness data. The document, Best Practices for Consumer Wearables & Wellness Apps & Devices, was drafted by FPF with input from a wide range of stakeholders, including privacy advocates, companies, and regulators. The Best Practices guidelines set forth a Fair Information Practice Principles-based trust framework that builds on existing legal expectations to provide a set of best practices providing appropriate protections given the nature and sensitivity of the data.
Last week, the Department of Health and Human Services Office for Civil Rights launched the long-awaited Phase 2 HIPAA Audit Program. Earlier this month, the agency posted two resolution agreements that continue the trend toward big dollar settlement amounts and a focus on security risk assessments and business associate agreements. With Phase 2 HIPAA Audits underway and more full-scale compliance reviews triggered by data breach reports, it is more important than ever to appropriately protect health information.
Following the launch of its mHealth Developer Portal last October, the HHS Office for Civil Rights has released guidance clarifying how HIPAA applies to mobile health apps. Ensuring that developers understand their legal obligations is critical to protecting consumer privacy and security, especially now that there are more than 165,000 health apps available in the iTunes and Android app stores. A more clear understanding of how the rules apply can also help bring down barriers to innovation.
Last month, tucked into a 2,000-page spending bill, the Cybersecurity Information Sharing Act of 2015 (CISA) was enacted into law. Years in the making, CISA is intended to incentivize organizations to share cyber threat indicators with the federal government and to promote the dissemination of this information to organizations facing similar threats. The spending bill included a number of other cybersecurity provisions covering topics ranging from federal preparedness to foreign policy strategy. Most notably, the bill directs the Department of Health and Human Services to develop cybersecurity best practices for organizations in the healthcare industry. The bill also directs federal agencies to create new plans to fortify federal information systems and identify cyber-related gaps in the federal workforce.