October 25, 2021

Volume XI, Number 298


October 25, 2021

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HHS Task Group Releases Cybersecurity Guidelines for the Health Care Industry

Health care is one of the most complex and socially impactful areas of digitalization. Ensuring cybersecurity of health care operations, therefore, is of paramount importance – because potential vulnerabilities may lead not only to financial or technical exposures, but to lapses in life-or-death situations for patients.

To assist practitioners with education and guidelines, and in pursuance of Cybersecurity Act of 2015 (Public Law 114-113), Section 405(d), the Department of Health and Human Services created a “405(d) Task Group” in May 2017, involving, more than 150 health care and cybersecurity experts. The result of their collaborative work became a voluntary guideline entitled “Health Industry Cybersecurity Practices: Managing Threats and Protecting Patients,” which was released at the end of 2018.

The document provides practical, practice recommendations for the five most prevalent cybersecurity threats:

• E-mail Phishing Attack
• Ransomware Attack
• Loss or Theft of Equipment or Data
• Insider, Accidental or Intentional Data Loss
• Attacks Against Connected Medical Devices That May Affect Patient Safety

The document is written in an accessible, well-structured way, with clear explanations of the background information and main concepts. More in-depth technical advice is provided in the accompanying two volumes, which describe 10 specific practices to counteract the threats (Technical Volume 1: Cybersecurity Practices for Small Organizations and Technical Volume 2: Cybersecurity Practices for Medium and Large Organizations). These 10 recommended practical approaches focus on:

1. E-mail protection systems
2. Endpoint protection systems
3. Access management
4. Data protection and loss prevention
5. Asset management
6. Network management
7. Vulnerability management
8. Incident response
9. Medical device security
10. Cybersecurity policies

In addition, the 405(d) Task Group made available “Resources and Templates” supporting health industry cybersecurity practices, and are developing a specific “toolkit,” to be released later. In the meantime, the Office of the National Coordinator for Health Information Technology (ONC), in collaboration with HHS, have already developed and made available a related “Security Risk Assessment” tool (most recent version published in October 2018).

While the recommendations in the latest “Health Industry Cybersecurity Practices” document are tailored to the health care industry, they are consistent with the guidance identified in the NIST Cybersecurity Framework. To further advance public discussion and mutual education, the Task Group welcomes more direct involvement by industry stakeholders. The Task Group’s website also provides links to tools and other regulatory guidance documents related to cybersecurity and data privacy.

© 2021 Faegre Drinker Biddle & Reath LLP. All Rights Reserved.National Law Review, Volume IX, Number 18

About this Author

Svetlana Lyapustina Ph.D. a pharmaceutical scientist with Drinker Biddle
Senior Director, Science, Regulation, & Policy

Svetlana Lyapustina, Ph.D. counsels individual companies and consortia comprised of industry, government and academia representatives on a wide range of topics related to medical product development (pharmaceuticals, medical devices, biologics, and combination products), quality control, manufacturing, regulatory compliance, patient adherence, and regulatory submissions.

Svetlana has represented clients in interactions with the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), Health Canada, the Medicines...

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