On March 8, 2023, the United States Department of Health and Human Services (“HHS”), through the Administration for Strategic Preparedness and Response and the Health Sector Coordinating Counsel Joint Cybersecurity Working Group, released an updated version of its Cybersecurity Framework Implementation Guide (the “Guide”) “to help the public and private health care sectors prevent cybersecurity incidents.”  Specifically, the Guide aims to help healthcare organizations leverage the NIST Cybersecurity Framework to “determine their cybersecurity goals, assess their current cybersecurity practices, or lack thereof, and help identify gaps for remediation.”  

Leveraging the NIST CSF.  The Guide, which is voluntary, is intended to help healthcare organizations strengthen their cybersecurity programs and reduce risk by implementing the National Institute for Standards and Technology (“NIST”) Cybersecurity Framework (“CSF” or “Framework”).  Originally released in 2014 and updated in 2018, the NIST CSF is a framework designed to assist organizations with developing, aligning, and prioritizing cybersecurity activities with business requirements, risk tolerances, and resources.  Globally, organizations, industries, and government agencies have increasingly relied upon the Framework to establish cybersecurity programs and measure their maturity. 

Roadmap for Implementation.  The Guide is intended to serve “as a roadmap for health care and private health sector organizations to implement the NIST Cybersecurity Framework, including:

  • Guiding risk management principles and best practices[;]
  • Providing common language to address and manage cybersecurity risk[;]
  • Outlining a structure for organizations to understand and apply cybersecurity risk management[;] and
  • Identifying effective standards, guidelines, and practices to manage cybersecurity risk cost-effectively based on business needs[.]” 

According to the Guide, a comprehensive cybersecurity framework will “provide a common language and structure for discussions around risk and the methods and tools used to manage risk to a level that is not only acceptable to the organization but to other stakeholders such as business partners, customers, and industry and governmental regulators.”

The Guide also notes that, pursuant to 2021 amendments to the HI-TECH Act, HHS must “consider a health care entity’s adoption of recognized security practices, as defined by PL 116-321, when determining the length and outcome of audits or the amount of fines or extent of penalties.”  The relevant definition of “recognized security practices” includes NIST standards and guidelines, such as the Framework.

Looking Ahead.  HHS’s Guide is another cybersecurity development in light of the White House’s release of its new U.S. National Cybersecurity Strategy, which outlines the need for minimum cybersecurity standards in critical sectors to enhance national security and public safety.  In February 2013, healthcare was identified as a critical infrastructure sector under Presidential Policy Directive 21.  The Guide also follows shortly after NIST’s request for public comment on potential significant updates to the Framework, including expanding the Framework’s five functions (Identify, Protect, Detect, Respond, and Recover) to add a new function on cybersecurity governance (“Govern”).  NIST is still accepting comments on its potential significant updates to the Framework until March 17, 2023. 

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Photo of Ashden Fein Ashden Fein

Ashden Fein is a vice chair of the firm’s global Cybersecurity practice. He advises clients on cybersecurity and national security matters, including crisis management and incident response, risk management and governance, government and internal investigations, and regulatory compliance.

For cybersecurity matters, Ashden counsels clients…

Ashden Fein is a vice chair of the firm’s global Cybersecurity practice. He advises clients on cybersecurity and national security matters, including crisis management and incident response, risk management and governance, government and internal investigations, and regulatory compliance.

For cybersecurity matters, Ashden counsels clients on preparing for and responding to cyber-based attacks, assessing security controls and practices for the protection of data and systems, developing and implementing cybersecurity risk management and governance programs, and complying with federal and state regulatory requirements. Ashden frequently supports clients as the lead investigator and crisis manager for global cyber and data security incidents, including data breaches involving personal data, advanced persistent threats targeting intellectual property across industries, state-sponsored theft of sensitive U.S. government information, extortion and ransomware, and destructive attacks.

Additionally, Ashden assists clients from across industries with leading internal investigations and responding to government inquiries related to the U.S. national security and insider risks. He also advises aerospace, defense, and intelligence contractors on security compliance under U.S. national security laws and regulations including, among others, the National Industrial Security Program (NISPOM), U.S. government cybersecurity regulations, FedRAMP, and requirements related to supply chain security.

Before joining Covington, Ashden served on active duty in the U.S. Army as a Military Intelligence officer and prosecutor specializing in cybercrime and national security investigations and prosecutions — to include serving as the lead trial lawyer in the prosecution of Private Chelsea (Bradley) Manning for the unlawful disclosure of classified information to Wikileaks.

Ashden currently serves as a Judge Advocate in the
U.S. Army Reserve.

Photo of Anna D. Kraus Anna D. Kraus

Anna Durand Kraus advises on issues relating to the complex array of laws governing the health care industry. Her background as Deputy General Counsel to the U.S. Department of Health and Human Services (“HHS”) gives her broad experience with, and valuable insight into…

Anna Durand Kraus advises on issues relating to the complex array of laws governing the health care industry. Her background as Deputy General Counsel to the U.S. Department of Health and Human Services (“HHS”) gives her broad experience with, and valuable insight into, the programs and issues within the purview of HHS, including Medicare, Medicaid, fraud and abuse, and HIPAA privacy and security. Anna is co-chair of the firm’s Health Care Industry practice group.

Anna regularly advises clients on Medicare reimbursement matters, particularly those arising under Part B and the Part D prescription drug benefit. She also has extensive experience with the Medicaid Drug Rebate program. She assists numerous pharmaceutical and device manufacturers, health care providers, pharmacy benefit managers, and other health care industry stakeholders to navigate the challenges and opportunities presented by the Affordable Care Act.

Anna is a trusted adviser on health information privacy, security and breach notification issues, including those arising under the Health Insurance Portability and Accountability Act (“HIPAA”) and the Health Information Technology for Economic and Clinical Health (“HITECH”) Act. Her background in this area dates back to the issuance of the original HIPAA privacy regulations.

Anna’s clients depend on her to guide them through compliance with the Anti-Kickback statute, the Stark regulations, and other laws preventing fraud and abuse in the health care industry. Her deep knowledge of these laws has made her an important component of the firm’s representation of pharmaceutical companies and health care organizations under federal investigation or facing allegations under the False Claims Act. In addition, clients contemplating acquisitions in the health care sector rely on her to guide due diligence efforts.

Photo of Caleb Skeath Caleb Skeath

Caleb Skeath advises clients on a broad range of cybersecurity and privacy issues, including cybersecurity incident response, cybersecurity and privacy compliance obligations, internal investigations, regulatory inquiries, and defending against class-action litigation. Caleb holds a Certified Information Systems Security Professional (CISSP) certification.

Caleb specializes in assisting…

Caleb Skeath advises clients on a broad range of cybersecurity and privacy issues, including cybersecurity incident response, cybersecurity and privacy compliance obligations, internal investigations, regulatory inquiries, and defending against class-action litigation. Caleb holds a Certified Information Systems Security Professional (CISSP) certification.

Caleb specializes in assisting clients in responding to a wide variety of cybersecurity incidents, ranging from advanced persistent threats to theft or misuse of personal information or attacks utilizing destructive malware. Such assistance may include protecting the response to, and investigation of an incident under the attorney-client privilege, supervising response or investigation activities and interfacing with IT or information security personnel, and advising on engagement with internal stakeholders, vendors, and other third parties to maximize privilege protections, including the negotiation of appropriate contractual terms. Caleb has also advised numerous clients on assessing post-incident notification obligations under applicable state and federal law, developing communications strategies for internal and external stakeholders, and assessing and protecting against potential litigation or regulatory risk following an incident. In addition, he has advised several clients on responding to post-incident regulatory inquiries, including inquiries from the Federal Trade Commission and state Attorneys General.

In addition to advising clients following cybersecurity incidents, Caleb also assists clients with pre-incident cybersecurity compliance and preparation activities. He reviews and drafts cybersecurity policies and procedures on behalf of clients, including drafting incident response plans and advising on training and tabletop exercises for such plans. Caleb also routinely advises clients on compliance with cybersecurity guidance and best practices, including “reasonable” security practices.

Caleb also maintains an active privacy practice, focusing on advising technology, education, financial, and other clients on compliance with generally applicable and sector-specific federal and state privacy laws, including FERPA, FCRA, GLBA, TCPA, and COPPA. He has assisted clients in drafting and reviewing privacy policies and terms of service, designing products and services to comply with applicable privacy laws while maximizing utility and user experience, and drafting and reviewing contracts or other agreements for potential privacy issues.

Photo of Matthew Harden Matthew Harden

Matthew Harden is a cybersecurity and litigation associate in the firm’s New York office. He advises on a broad range of cybersecurity, data privacy, and national security matters, including cybersecurity incident response, cybersecurity and privacy compliance obligations, internal investigations, and regulatory inquiries. He…

Matthew Harden is a cybersecurity and litigation associate in the firm’s New York office. He advises on a broad range of cybersecurity, data privacy, and national security matters, including cybersecurity incident response, cybersecurity and privacy compliance obligations, internal investigations, and regulatory inquiries. He works with clients across industries, including in the technology, financial services, defense, entertainment and media, life sciences, and healthcare industries.

As part of his cybersecurity practice, Matthew provides strategic advice on cybersecurity and data privacy issues, including cybersecurity investigations, cybersecurity incident response, artificial intelligence, and Internet of Things (IoT). He also assists clients with drafting, designing, and assessing enterprise cybersecurity and information security policies, procedures, and plans.

As part of his litigation and investigations practice, Matthew leverages his cybersecurity experience to advise clients on high-stakes litigation matters and investigations. He also maintains an active pro bono practice focused on veterans’ rights.

Matthew currently serves as a Judge Advocate in the U.S. Coast Guard Reserve.

Photo of Olivia Vega Olivia Vega

Olivia Vega provides strategic advice to global companies on a broad range of privacy, health care, and technology issues, including in technology transactions, mergers and acquisitions, and regulatory compliance. Within her practice, Olivia counsels clients on navigating the complex web of federal and…

Olivia Vega provides strategic advice to global companies on a broad range of privacy, health care, and technology issues, including in technology transactions, mergers and acquisitions, and regulatory compliance. Within her practice, Olivia counsels clients on navigating the complex web of federal and state privacy and data security laws and regulations, including on topics such as HIPAA, California’s Confidentiality of Medical Information Act, and the California Consumer Privacy Act. In addition, Olivia maintains an active pro bono practice.