State of Play:
In December, the Office of Civil Rights (OCR) released proposed rules that would make revisions to the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule to reduce barriers to coordinated care. The Food and Drug Administration (FDA) released an action plan on how to regulate artificial intelligence and machine learning as a medical device. In December, President Trump signed H.R. 7898 into law that would allow the Secretary of Health and Human Services (HHS) the ability to take the security practices of a covered entity/business associate into consideration when issuing fines under HIPAA.
- On January 7, the Confidentiality Coalition held a walkthrough of the Office of Civil Rights’ (OCR) proposed changes to the HIPAA Privacy Rule.
- On January 4, the Confidentiality Coalition submitted comments to the Centers for Medicare and Medicaid Services (CMS) on their proposed rule on provider burden and promoting interoperability.
- On December 22, the Confidentiality Coalition submitted comments to the Centers for Medicare and Medicaid Services requesting an extension of the comment period on their proposed rule on provider burden and promoting interoperability.
- On December 15, the Confidentiality Coalition submitted comments to the Food and Drug Administration (FDA) on communicating cybersecurity vulnerabilities to patients.
- On November 19, Sam Segall, Marisa Bass and Adam Landsman with CLEAR gave a presentation to the Confidentiality Coalition on their Health Pass platform.
- On October 26, the Confidentiality Coalition submitted comments to the Federal Communications Commission (FCC) on healthcare exemptions to the Telephone Consumer Privacy Act (TCPA).
- On October 15, Ben Moscovitch, Ashley Ashworth and Molly Murray from The Pew Charitable Trusts gave a presentation to the Confidentiality Coalition on their health information technology survey.
- In September, Alice Leiter, Vice President and Senior Counsel for the eHealth Initiative gave a presentation to the Confidentiality Coalition on their draft consumer privacy framework for health data done with the Center for Democracy and Technology.
- In September, the Confidentiality Coalition submitted comments to the eHealth Initiative on their draft consumer privacy framework for health data done with the Center for Democracy and Technology.
- In August, the Confidentiality Coalition submitted comments to the Federal Trade Commission for their data portability workshop.
- On July 24, the Confidentiality Coalition’s counsel Diane Sacks gave a TCPA Update on legal developments regarding the Telephone Consumer Protection Act (TCPA).
- On June 18, John Riggi, Senior Advisor for Cybersecurity and Risk Advisory Services with the American Hospital Association gave a presentation to Confidentiality Coalition members on cyber and privacy challenges related to COVID-19 responses.
- In June, the Confidentiality Coalition shared a side-by-side comparison of pending legislative bills on COVID-19 contact tracing and the privacy implications of those bills.
- In May, Paul Uhrig with The Commons Project gave a presentation to Confidentiality Coalition on the partnership between CommonHealth and COVIDCheck to digitally monitor COVID-19 treatment and current impact.
- On April 28, the Coalition sent comments to the FDA regarding modernization of the agency’s data strategy
- On April 16, HLC’s Confidentiality Coalition sent a letter to HHS Secretary Alex Azar, CMS Administrator Seema Verma and the U.S. National Coordinator for Health Information Technology, Dr. Don Rucker, requesting an extension of the time period for implementation of the CMS Interoperability and Patient Access Final Rule and the ONC Cures Act “Information Blocking” Final Rule. The rationale for the request was based on members’ inability to implement these rules due to their singular focus on COVID-19 emergency activities.
- In April, the Confidentiality Coalition communicated with ONC and CMS, requesting an extended time period — a minimum of 12 months — for compliance with and enforcement of each requirement specified in the interoperability rules, in light of the COVID-19 pandemic.
- On March 4, the Confidentiality Coalition presented at the Annual HIPAA Summit. “Can the Tension Between Treatment Coordination and Privacy Protection Goals be Harmonized?”
- Members of Confidentiality Coalition met with OCR staff to discuss the Telephone Communications Protection Act (TCPA) and its affect on HIPAA covered entities’ ability to communicate non-marketing health alerts to individuals.
- On March 19, Diane Sacks, counsel to the Confidentiality Coalition, walked members through privacy and security provisions in the final interoperability rules from the HHS Office of the National Coordinator of Health Information Technology (ONC) and the Centers for Medicare and Medicaid (CMS).
- Written testimony from Confidentiality Coalition Chair, Tina Grande to House Committee on Veterans’ Affairs Subcommittee on Technology Modernization hearing “Data Privacy and Portability at VA: Protecting Veterans’ Personal Data.”
- Confidentiality Coalition comments on the House Energy and Commerce Committee’s draft privacy legislation.
- The Confidentiality Coalition met with the Office of Management and Budget to discuss privacy-related concerns with the CMS and ONC interoperability rules.