The Office of Civil Rights (OCR) of the U.S. Department of Health and Human Services (HHS) has continued its enforcement of HIPAA’s privacy and security rules in the new administration, announcing a number of settlements of alleged violations in the first seven months of 2021.  This settlement activity followed a few other significant HIPAA developments

The new year began with an unusual amount of activity related to the Health Insurance Portability and Accountability Act (HIPAA). Health care providers, health plans, health care clearinghouses, and business associates subject to HIPAA will need to consider three significant developments—one regulatory, one legislative, and one judicial—relating to the Privacy and Security Rules under HIPAA and the related Health Information Technology for Economic and Clinical Health Act of 2009 (HITECH).
Continue Reading  A Fast Start: 2021 Begins With Major HIPAA Developments

Following a very quiet start to HIPAA settlement activity in 2020, the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) recently announced eight settlements with covered entities and business associates.

The most recent of these announcements involves the second-largest HIPAA settlement amount in OCR’s history, amounting to $6.85 million.

Health care providers, health plans, and others who are subject to HIPAA are sure to have questions about when they may disclose information about individuals who have contracted, or been exposed to, Coronavirus (COVID-19).

To address these questions, the Office of Civil Rights, U.S. Department of Health and Human Services, has issued guidance.  First, it

Following on the heels of a few relatively small HIPAA settlements, the U.S. Department of Health and Human Services Office of Civil Rights (OCR) announced that it has imposed $2,154,000 in civil monetary penalties against Jackson Health System in Florida for its failure to meet HIPAA privacy and security requirements.  The OCR announcement and accompanying

After a quiet winter, the Department of Health and Human Services’ Office for Civil Rights (OCR) revived with the spring, issuing a set of frequently asked questions and two recent announcements.

The FAQs address the situation where an individual requests a covered entity to disclose protected health information (“PHI”) to an app. The covered entity

On February 7, 2019, the Office of Civil Rights (OCR) of the U.S. Department of Health and Human Services published the resolution agreement for its final HIPAA settlement of 2018.  The resolution agreement cited two breach notifications that OCR received from the parent of several hospitals in California.  In 2013, the provider notified OCR of a breach that occurred when one of its contractors removed electronic security protections from a server.  This breach affected more than 50,000 individuals.  In 2015, the provider submitted notice of a second breach, this one resulting from an employee’s activation of the wrong website, affecting more than 11,000 individuals.
Continue Reading  OCR Closes the Book on 2018 With $3 Million HIPAA Settlement

A relatively quiet year for HIPAA enforcement is ending with a small flourish.  The Office of Civil Rights of the Department of Health and Human Services (HHS) has announced two settlements with covered entities within the span of eight days.

The first settlement involved Advanced Care Hospitalists (ACH), a company that provides internal medicine physicians to hospitals and nursing homes in Florida.  In 2014, ACH received notice from a local hospital that individually identifiable patient information had been posted on the website of a third party billing provider.  ACH reported the breach, which ultimately led to an HHS investigation. HHS found that:

  • The disclosure affected 9,225 patients.
  • ACH failed to enter into a business associate agreement with one or more vendors who had access to protected health information (PHI).
  • ACH did not implement privacy, security, or breach notification policies and procedures until after the breach was discovered.
  • ACH failed to conduct a security risk analysis until after the breach was discovered.

To settle these matters, ACH agreed to pay a $500,000 penalty and fulfill its obligations under a supervised corrective action plan that focuses on the identified failures.

The second settlement followed from a complaint lodged with HHS against Pagosa Springs Medical Center (PSMC) in Colorado.   The ensuing investigation revealed:

  • The impermissible disclosure of the PHI of at least 557 individuals to a former employee whose access to PSMC’s information systems was not revoked upon termination of employment.
  • The impermissible disclosure of the PHI of at least 557 individuals to a business associate without an appropriate business associate agreement.

Continue Reading  A Pair of Year-End HIPAA Settlements

The Office of Civil Rights of the Department of Health and Human Services has announced settlements with three different Boston-area hospitals for allegedly compromising the privacy of protected health information by inviting documentary film crews on premises without first obtaining patient authorization.  The three settlements call for a total of almost $1 million in penalty payments and require each of the hospitals to undertake corrective action.  The corrections are not the same for each hospital and range from workforce education and communication to the establishment of specific procedures, for example, for deciding when to allow media access and for putting safeguards in place to monitor film crew activity.
Continue Reading  Beware the Bright Lights

Imagine a breach in the privacy of protected health information.  The violation of an individual’s HIPAA rights may be clear, but the individual cannot sue under HIPAA.  Courts have consistently held that HIPAA provides no private right of action.

In the recent case of Lee-Thomas v. Lab Corp., an individual brought suit, claiming that her HIPAA rights had been violated.  When hospitalized, she had been  asked to submit medical information on a computer.  She alleged that the information she entered was visible to another patient at a nearby computer station.  The court did not reach the question of whether the proximity of the computers resulted in a HIPAA violation.  It dismissed the claim, observing that HIPAA limits enforcement actions to the U.S. Department of Health and Human Services and states’ attorneys general.

The absence of a private right of action under HIPAA significantly reduces the risks faced by covered entities and business associates, but it does not shield them against all litigation and liability. Lawsuits for the improper disclosure of personal medical information have been brought under different theories, including common law breaches of privacy and breaches of contract.  Last year, Anthem Inc. settled a class action, arising from a large 2015 data breach, for $115 million. Currently, litigation is being pursued under non-HIPAA claims for disclosures that have resulted from mailing practices, including the use of window envelopes and incorrect addresses.  Case law is emerging, and it is possible that courts will refer to HIPAA’s standards as setting the bar for the privacy and data security safeguards that should be implemented and followed, but individuals who sue for breaches of those safeguards will need to base their claims on something other than a HIPAA violation.
Continue Reading  HIPAA Enforcement: Where’s the Action?