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The Department of Health and Human Services’ Office for Civil Rights has released a Request for information (RFI) related to two outstanding requirements of the Health Information Technology for Economic and Clinical Health Act of 2009 (HITECH Act).
The HITECH Act, as amended in 2021 by the HIPAA Safe Harbor Act, requires the HHS consider the security practices that have been implemented by HIPAA-regulated entities when considering financial penalties and other remedies to resolve potential HIPAA violations discovered during investigations and audits.
The aim of the HIPAA Safe Harbor Act is to encourage HIPAA-regulated entities to implement cybersecurity best practices. The reward for organisations that have followed industry-standard security best practices for the 12 months prior to a data breach occurring is lower financial penalties for data breaches and less scrutiny by the HHS .
Another outstanding requirement that dates back to when the HITECH Act was signed into law, is for the HHS to share a percentage of the civil monetary penalties (CMPs) and settlement payments with individuals who have been harmed as a result of the violations for which the penalties have been applied. The HITECH Act calls for a methodology to be established by the HHS for determining appropriate amounts to be shared, based on the nature and extent of the HIPAA violation and the nature and extent of the harm that has been caused.
Earlier this year, the recently appointed Director of the HHS’ Office for Civil Rights (OCR) – Lisa J. Pino – confirmed that these two requirements of the HITECH Act were being addressed this year. Yesterday, OCR published the RFI in the Federal Register seeking public comment on these two requirements of the HITECH Act.
Specifically, OCR is seeking feedback on what constitutes “Recognized Security Practices,” the recognized security practices that are being implemented to safeguard electronic protected health information by HIPAA-compliant entities, and how those entities anticipate adequately demonstrating that recognized security practices are in place. OCR would also like to learn about any implementation issues that those entities would like to be clarified by OCR, either through further rulemaking or guidance, and suggestions on the action that should initiate the beginning of the 12-month look-back period, as that is not stated in the HIPAA Safe Harbor Act.
One of the main issues with the requirement to share CMPs and settlements with victims is the HITECH Act has no definition of harm. OCR is seeking comment on the types of “harms” that should be considered when distributing a percentage of SMPs and settlements, and suggestions on potential methodologies for sharing and distributing monies to harmed individuals.
“This request for information has long been anticipated, and we look forward to reviewing the input we receive from the public and regulated industry alike on these important topics,” said Pino. “I encourage those who have been historically underserved, marginalized, or subject to discrimination or systemic disadvantage to comment on this RFI, so we hear your voice and fully consider your interests in future rulemaking and guidance.”
In order to be considered, comments must be submitted to OCR by June 6, 2022.