HHS Releases Final Rules with Safe Harbors for Cybersecurity Donations

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On Friday last week, the Department of Health and Human Services’ Centers for Medicare and Medicaid Services (CMS) and Office of Inspector General (OIG) published final rules that aim to improve the coordination of care and reduce regulatory barriers. Both final rules contain safe harbor provisions that allow hospitals and healthcare delivery systems to donate cybersecurity technology to physician practices.

The CMS released the final version of the 627-page Modernizing and Clarifying the Physician Self-Referral Regulations, commonly called Stark Law, and the OIG finalized revisions to the 1,049-page Safe Harbors Under the Anti-Kickback Statute and Civil Monetary Penalty Rules Regarding Beneficiary Inducements.

Physician practices often have limited resources, which makes it difficult for them to implement solutions to address cybersecurity risks. Without the necessary protections, sensitive healthcare data could be accessed by unauthorized individuals, stolen, deleted, or encrypted by threat actors. Threat actors could also conduct attacks on small physician practices and use them to gain access to the healthcare systems to which they connect.

When the rules were first proposed, commenters emphasized the need for a safe harbor to allow non-abusive, beneficial arrangements between physicians and other healthcare providers, such donations of cybersecurity solutions to help safeguard the healthcare ecosystem. The CMS first proposed the changes in October 2019 as part of the Regulatory Sprint to Coordinated Care.

The CMS final rule clarifies the Stark Law exceptions concerning donations of electronic health record donations to physicians, expanding the EHR exception to include cybersecurity software and services. A standalone exception has also been introduced for broader cybersecurity donations, including donations of cybersecurity hardware.

“These finalized exceptions provide new flexibility for certain arrangements, such as donations of cybersecurity technology that safeguard the integrity of the healthcare ecosystem, regardless of whether the parties operate in a fee-for-service or value-based payment system,” said the CMS.

The changes recognize the risk of cyberattacks on the healthcare sector and create a safe harbor for cybersecurity technology and services to protect cybersecurity-related hardware, and will help to ensure that cybersecurity software and hardware are available to all healthcare providers of all sizes.

The safe harbor applies to, but is not limited to, “software that provides malware prevention, software security measures to protect endpoints that allow for network access control, business continuity software, data protection and encryption and email traffic filtering.” The exception also covers the “hardware that is necessary and used predominantly to implement, maintain or re-establish cybersecurity” and a broad range of cybersecurity services such as updating and maintaining software and cybersecurity training services. There is no distinction in the rule between locally installed and cloud-based cybersecurity solutions.

Under the cybersecurity exception, recipients are not required to contribute to the cost of the donated cybersecurity technology or services. Under the EHR exception, the cost contribution requirement for donations of EHR items or services is retained.

“It is our position that allowing entities to donate cybersecurity technology and related services to physicians will lead to strengthening of the entire health care ecosystem,” said the HHS.

The final rules are due to be published in the federal register on December 2, 2020 and are expected to take effect on January 19, 2021.

Author: Steve Alder has many years of experience as a journalist, and comes from a background in market research. He is a specialist on legal and regulatory affairs, and has several years of experience writing about HIPAA. Steve holds a B.Sc. from the University of Liverpool.

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