Pursuant to legislation passed in 2021, covered entities and business associates subject to HIPAA and facing potential regulatory enforcement may receive some credit lessening to reduce enforcement penalties if they had implemented Recognized Security Practices (RSPs) within the prior 12 months. However, what may constitute RSPs and how a covered entity or business associate can demonstrate implementation of RSPs to receive such credit had not been clear. Now, the Department of Health and Human Services is seeking to provide clarity. (more…)
Digital health companies should take note of new data privacy and security developments under the Health Insurance Portability and Accountability Act (HIPAA) that can affect product planning and customer negotiations.
The U.S. Department of Health and Human Services Office for Civil Rights (OCR) has released a request for information (RFI) seeking input on (1) how covered entities implement recognized security practices, which OCR considers in enforcement matters and (2) the different types of harm that individuals experience from HIPAA violations in order to consider how OCR may share enforcement recoveries with individuals harmed. Digital health companies subject to HIPAA should consider submitting comments by the June deadline to ensure that the evolving digital health industry has a voice in establishing industry best practices and advocating for continued flexibility in the implementation of security standards that suit their unique business needs distinct from traditional covered entities and business associates. (more…)
Many companies hope to benefit from amassing large amounts of data by mining it for market insights, creating internal business models, and supporting strategic, data-driven decisions. But as companies collect and store increasingly enormous volumes of data, they may unknowingly take on significant legal risks, including potential violations of data privacy laws and increased exposure to U.S. litigation discovery obligations. One way that businesses can mitigate these risks is to de-identify the data they collect and store.
On December 10, 2020, the U.S. Department of Health and Human Services (HHS) Office of Civil Rights (OCR) released a proposed rule (the Proposed Rule) that would make a number of key changes to the Privacy Rule under the Health Insurance Portability and Accountability Act of 1996 and the Health Information Technology for Economic and Clinical Health Act of 2009 (collectively, HIPAA). HHS stated that the Proposed Rule is intended to reduce burdens that may limit or discourage care coordination and case management communications among individuals and HIPAA-covered entities while continuing to protect the privacy of individuals. The proposed changes are designed to lead to increased data access, sharing, and portability and to further HHS’s emphasis on patients’ right of information access, which has been highlighted through a series of enforcement actions in 2020. If enacted as proposed, the amendments would require healthcare providers and electronic health records (EHR) vendors to update policies and disclosures related to information access and perhaps even to redesign certain EHR processes. Comments are due 60 days after publication in the Federal Register.