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. 

Photo of Ashden Fein Ashden Fein

Ashden Fein is co-chair of Covington’s Data Privacy and 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. Ashden also serves as lead counsel…

Ashden Fein is co-chair of Covington’s Data Privacy and 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. Ashden also serves as lead counsel in criminal, civil, and internal investigations involving cybersecurity, insider risk, and U.S. national security issues.

Ashden regularly 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.

Ashden also assists clients from across industries with leading internal investigations and responding to government inquiries related to U.S. national security and insider risks. He frequently represents government contractors in False Claims Act matters involving cybersecurity and national security. Additionally, he 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 is a retired U.S. Army officer.

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 helps companies manage their most complex and high‑stakes cybersecurity and data security challenges, combining deep regulatory insight, technical fluency, and practical judgment informed by leading incident response matters.

Caleb Skeath advises in‑house legal and security teams on the full lifecycle of…

Caleb Skeath helps companies manage their most complex and high‑stakes cybersecurity and data security challenges, combining deep regulatory insight, technical fluency, and practical judgment informed by leading incident response matters.

Caleb Skeath advises in‑house legal and security teams on the full lifecycle of cybersecurity and privacy risk—from governance and preparedness through incident response, regulatory engagement, and follow‑on litigation. A Certified Information Systems Security Professional (CISSP), he is trusted by clients across highly regulated and technology‑driven sectors to provide clear, practical guidance at moments when legal judgment, technical understanding, and business realities must be aligned.

Caleb has deep experience leading and overseeing responses to complex cybersecurity incidents, including ransomware, data theft and extortion, business email compromise, advanced persistent threats and state-sponsored threat actors, insider threats, and inadvertent data loss. He regularly helps in‑house counsel structure and manage investigations under attorney‑client privilege; coordinate with internal IT, information security, and executive stakeholders; and engage with forensic firms, crisis communications providers, insurers, and law enforcement. A central focus of his practice is advising on notification obligations and strategy, including the application of U.S. federal and state data breach notification laws and requirements along with contractual notification obligations, and helping companies make defensible, risk‑informed decisions about timing, scope, and messaging.

In addition to his work responding to cybersecurity incidents, Caleb works closely with clients’ legal, technical, and compliance teams on cybersecurity governance, regulatory compliance, and pre‑incident planning. He has extensive experience drafting and reviewing cybersecurity policies, incident response plans, and vendor contract provisions; supervising cybersecurity assessments under privilege; and advising on training and tabletop exercises designed to prepare organizations for real‑world incidents. His work frequently involves translating evolving regulatory expectations into actionable guidance for in‑house counsel, including in highly-regulated sectors such as the financial sector (including compliance with NYDFS cybersecurity regulations, the Computer Security Incident Notification Rule, and GLBA guidelines and guidance) and the pharmaceutical and healthcare sector (including compliance with GxP standards, FDA medical device guidance, and HIPAA).

Caleb’s practice also addresses evolving and emerging areas of cybersecurity and data security law, including advising clients on compliance with the Department of Justice’s Data Security Program, CISA‑related security requirements for restricted transactions, and preparation for new regulatory regimes such as the CCPA cybersecurity audit requirements and federal incident reporting obligations. He regularly counsels clients on how artificial intelligence and connected devices intersect with cybersecurity, privacy, and consumer protection risk, and how to support innovation while managing regulatory exposure.

Caleb also has extensive experience helping clients navigate high-stakes cybersecurity-related inquiries from the Federal Trade Commission, state Attorneys General, and other sector-specific regulators, including incident-specific inquiries as well as broader inquiries related to an entity’s cybersecurity practices and the security of product or service offerings. For companies that have entered into cybersecurity-related settlement agreements with regulators, Caleb has helped guide them through compliance with settlement agreement obligations, including navigating required third-party assessments and strategically responding to cybersecurity incidents that can arise while a company is subject to a settlement agreement. Caleb also routinely works hand-in-hand with colleagues in Covington’s class action litigation, commercial litigation, and insurance recovery practices to prepare for and successfully navigate incident-related disputes that can devolve into litigation.

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.