The Office for Civil Rights (OCR) has been moving swiftly to provide guidance on addressing key regulatory issues to aid in the fight to contain and defeat COVID-19. Some of the latest developments include exercising its enforcement discretion on certain good faith disclosures of protected health information (PHI) by business associates, adding FAQs for telehealth providers, and a resource page on its website for COVID-19 issues.

A common thread through all of the federal and state governmental briefings on the COVID-19 is that understanding the spread; managing healthcare personnel, equipment, and personal protective equipment (PPE); and other necessary resources requires data. Roger Severino, OCR Director, recognized the need for “quick access to COVID-19 related health data to fight this pandemic.” Because business associates have limitations on the circumstances under which critical data can be used and disclosed, despite the critical role they often play in storing and analyzing data, “[g]ranting HIPAA business associates greater freedom to cooperate and exchange information with public health and oversight agencies can help flatten the curve and potentially save lives,” Severino added.

The HIPAA Privacy Rule already permits covered entities to provide the kind of data that is needed, however, current regulations allow a HIPAA business associate to use and disclose PHI for public health and health oversight purposes only if expressly permitted by its business associate agreement with a HIPAA covered entity. It is common for business associate agreements to be drafted very narrowly, permitting only specified uses and disclosure. Thus, when federal public health authorities and health oversight agencies, state and local health departments, and state emergency operations centers have requested PHI from HIPAA business associates (i.e., a disclosure of PHI), or requested that business associates perform public health data analytics on such PHI (i.e., a use of PHI by the business associate) for the purpose of ensuring the health and safety of the public during the COVID-19 national emergency, some HIPAA business associates have been unable to timely participate in these efforts because their BAAs do not expressly permit them to make such uses and disclosures of PHI.

To address this issue, OCR announced that it will not impose penalties for violations of certain provisions of the HIPAA Privacy Rule against health care providers or their business associates for the good faith uses and disclosures of PHI by business associates for public health and health oversight activities during the COVID-19 nationwide public health emergency.

Specifically, the announcement provides that OCR will not impose penalties against a business associate or covered entity under certain Privacy Rule provisions if, and only if:

  • the business associate makes a good faith use or disclosure of the covered entity’s PHI for public health activities (see 45 CFR 164.512(b)), or health oversight activities (see 45 CFR 164.512(d)); and
  • the business associate informs the covered entity within ten (10) calendar days after the use or disclosure occurs (or commences, with respect to uses or disclosures that will repeat over time).

The OCR provides examples of good faith uses or disclosures:

  • the Centers for Disease Control and Prevention (CDC), or a similar public health authority at the state level, for the purpose of preventing or controlling the spread of COVID-19, consistent with 45 CFR 164.512(b).
  • the Centers for Medicare and Medicaid Services (CMS), or a similar health oversight agency at the state level, for the purpose of overseeing and providing assistance for the health care system as it relates to the COVID-19 response, consistent with 45 CFR 164.512(d).

It is important to note that while the OCR’s announcement provides some relief under HIPAA, it does not extend to other requirements or prohibitions under the Privacy Rule, or to any obligations under the HIPAA Security and Breach Notification Rules applicable to business associates and covered entities. This announcement also does not address other federal or state laws (including breach of contract claims) that might apply to the uses and disclosures of this information. Thus, business associates still need to be careful when using and disclosing PHI in these circumstances, although this announcement provides some welcomed relief and should aid the efforts to fight COVID-19.

Print:
EmailTweetLikeLinkedIn
Photo of Joseph J. Lazzarotti Joseph J. Lazzarotti

Joseph J. Lazzarotti is a Principal in the Morristown, New Jersey, office of Jackson Lewis P.C. He founded and currently leads the firm’s Privacy, e-Communication and Data Security Practice, edits the firm’s Privacy Blog, and is a Certified Information Privacy Professional (CIPP) with…

Joseph J. Lazzarotti is a Principal in the Morristown, New Jersey, office of Jackson Lewis P.C. He founded and currently leads the firm’s Privacy, e-Communication and Data Security Practice, edits the firm’s Privacy Blog, and is a Certified Information Privacy Professional (CIPP) with the International Association of Privacy Professionals. Trained as an employee benefits lawyer, focused on compliance, Mr. Lazzarotti also is a member of the firm’s Employee Benefits Practice Group.

In short, his practice focuses on the matrix of laws governing the privacy, security, and management of data, as well as the impact and regulation of social media. He also counsels companies on compliance, fiduciary, taxation, and administrative matters with respect to employee benefit plans.

Privacy and cybersecurity experience – Mr. Lazzarotti counsels multinational, national and regional companies in all industries on the broad array of laws, regulations, best practices, and preventive safeguards. The following are examples of areas of focus in his practice:

  • Advising health care providers, business associates, and group health plan sponsors concerning HIPAA/HITECH compliance, including risk assessments, policies and procedures, incident response plan development, vendor assessment and management programs, and training.
  • Coached hundreds of companies through the investigation, remediation, notification, and overall response to data breaches of all kinds – PHI, PII, payment card, etc.
  • Helping organizations address questions about the application, implementation, and overall compliance with European Union’s General Data Protection Regulation (GDPR) and, in particular, its implications in the U.S., together with preparing for the California Consumer Privacy Act.
  • Working with organizations to develop and implement video, audio, and data-driven monitoring and surveillance programs. For instance, in the transportation and related industries, Joe has worked with numerous clients on fleet management programs involving the use of telematics, dash-cams, event data recorders (EDR), and related technologies. He also has advised many clients in the use of biometrics including with regard to consent, data security, and retention issues under BIPA and other laws.
  • Assisting clients with growing state data security mandates to safeguard personal information, including steering clients through detailed risk assessments and converting those assessments into practical “best practice” risk management solutions, including written information security programs (WISPs). Related work includes compliance advice concerning FTC Act, Regulation S-P, GLBA, and New York Reg. 500.
  • Advising clients about best practices for electronic communications, including in social media, as well as when communicating under a “bring your own device” (BYOD) or “company owned personally enabled device” (COPE) environment.
  • Conducting various levels of privacy and data security training for executives and employees
  • Supports organizations through mergers, acquisitions, and reorganizations with regard to the handling of employee and customer data, and the safeguarding of that data during the transaction.
  • Representing organizations in matters involving inquiries into privacy and data security compliance before federal and state agencies including the HHS Office of Civil Rights, Federal Trade Commission, and various state Attorneys General.

Benefits counseling experience – Mr. Lazzarotti’s work in the benefits counseling area covers many areas of employee benefits law. Below are some examples of that work:

  • As part of the Firm’s Health Care Reform Team, he advises employers and plan sponsors regarding the establishment, administration and operation of fully insured and self-funded health and welfare plans to comply with ERISA, IRC, ACA/PPACA, HIPAA, COBRA, ADA, GINA, and other related laws.
  • Guiding clients through the selection of plan service providers, along with negotiating service agreements with vendors to address plan compliance and operations, while leveraging data security experience to ensure plan data is safeguarded.
  • Counsels plan sponsors on day-to-day compliance and administrative issues affecting plans.
  • Assists in the design and drafting of benefit plan documents, including severance and fringe benefit plans.
  • Advises plan sponsors concerning employee benefit plan operation, administration and correcting errors in operation.

Mr. Lazzarotti speaks and writes regularly on current employee benefits and data privacy and cybersecurity topics and his work has been published in leading business and legal journals and media outlets, such as The Washington Post, Inside Counsel, Bloomberg, The National Law Journal, Financial Times, Business Insurance, HR Magazine and NPR, as well as the ABA Journal, The American Lawyer, Law360, Bender’s Labor and Employment Bulletin, the Australian Privacy Law Bulletin and the Privacy, and Data Security Law Journal.

Mr. Lazzarotti served as a judicial law clerk for the Honorable Laura Denvir Stith on the Missouri Court of Appeals.