Per the notice below, the United States Office for Civil Rights (OCR) has taken action under the Health Insurance Portability and Accountability Act of 1996 (HIPAA) for not taking steps to prevent a cybersecurity hacking attack.

HHS Office for Civil Rights Imposes a $1,500,000 Civil Money Penalty Against Warby Parker in HIPAA Cybersecurity Hacking Investigation

Cyberattack resulted in unauthorized access to the protected health information of nearly 200,000 individuals.

The U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) announced a $1,500,000 civil money penalty against Warby Parker, Inc., a manufacturer and online retailer of prescription and non-prescription eyewear, concerning violations of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Security Rule, following the receipt of a breach report regarding the unauthorized access by one or more third parties to customer accounts.  OCR enforces the HIPAA Privacy, Security, and Breach Notification Rules (the HIPAA Rules), which set forth the requirements that covered entities (health plans, health care clearinghouses, and most health care providers), and business associates must follow to protect the privacy and security of protected health information (PHI).  The HIPAA Security Rule establishes national standards to protect individuals' electronic PHI (ePHI) that is created, received, used, disclosed, maintained, or transmitted by a covered entity.  It also requires appropriate administrative, physical, and technical safeguards to ensure the confidentiality, integrity, availability, and security of ePHI.  The civil money penalty resolves OCR’s investigation concerning this breach investigation.

“Identifying and addressing potential risks and vulnerabilities to electronic protected health information is necessary for effective cybersecurity and compliance with the HIPAA Security Rule,” said OCR Acting Director Anthony Archeval.  “Protecting individuals’ electronic health information means regulated entities need to be vigilant in implementing and complying with the Security Rule requirements before they experience a breach.”

In December 2018, OCR initiated an investigation following receipt of a breach report filed by Warby Parker.  The report stated that in November 2018, Warby Parker became aware of unusual, attempted log-in activity on its website.  Warby Parker reported that between September 25, 2018, and November 30, 2018, unauthorized third parties gained access to Warby Parker customer accounts by using usernames and passwords obtained from other, unrelated websites that were presumably breached.  This type of cyberattack is often referred to as “credential stuffing”.  In September 2020, Warby Parker filed an addendum to its December 2018 breach report, updating the number of individuals affected by the breach to 197,986.  The compromised ePHI included customer names, mailing addresses, e-mail addresses, certain payment card information, and eyewear prescription information.  Warby Parker also filed subsequent breach reports (each breach report affecting fewer than 500 persons) in April 2020, and June 2022, following similar attacks.

OCR’s investigation found evidence of three violations of the HIPAA Security Rule, including a failure to conduct an accurate and thorough risk analysis to identify the potential risks and vulnerabilities to ePHI in Warby Parker’s systems, a failure to implement security measures sufficient to reduce the risks and vulnerabilities to ePHI to a reasonable and appropriate level, and a failure to implement procedures to regularly review records of information system activity.  In September 2024, OCR issued a Notice of Proposed Determination seeking to impose a $1,500,000 civil money penalty.  Warby Parker waived its right to a hearing and did not contest OCR’s imposition of a civil money penalty.  Accordingly, in December 2024, OCR imposed a civil money penalty of $1,500,000.

The Notice of Proposed Determination may be found at: https://www.hhs.gov/hipaa/for-professionals/compliance-enforcement/agreements/warby-parker-npd/index.html.

The Notice of Final Determination may be found at: https://www.hhs.gov/hipaa/for-professionals/compliance-enforcement/agreements/warby-parker-nfd/index.html.

OCR recommends that health care providers, health plans, clearinghouses, and business associates that are covered by HIPAA take the following steps to mitigate or prevent cyber-threats:

• Identify where ePHI is located in the organization, including how ePHI enters, flows through, and leaves the organization’s information systems.
• Integrate risk analysis and risk management into the organization’s business processes.
• Ensure that audit controls are in place to record and examine information system activity.
• Implement regular reviews of information system activity.
• Utilize mechanisms to authenticate information to ensure only authorized users are accessing ePHI.
• Encrypt ePHI in transit and at rest to guard against unauthorized access to ePHI when appropriate.
• Incorporate lessons learned from incidents into the organization’s overall security management process.
• Provide workforce members with regular HIPAA training that is specific to the organization and to the workforce members’ respective job duties.

The HHS Breach Portal: Notice to the Secretary of HHS Breach of Unsecured Protected Health Information may be found at: https://ocrportal.hhs.gov/ocr/breach/breach_report.jsf.  OCR is committed to enforcing the HIPAA Rules that protect the privacy and security of peoples’ health information.  Guidance about the Privacy Rule, Security Rule, and Breach Notification Rules can also be found on OCR’s website.  If you believe that your or another person’s health information privacy or civil rights have been violated, you can file a complaint with OCR at: https://www.hhs.gov/ocr/complaints/index.html.