The U.S. Department of Health and Human Services’ Office for Civil Rights (“OCR”) recently announced resolution agreements with Raleigh Orthopaedic Clinic, P.A., (“Raleigh Orthopaedic”) and New York-Presbyterian Hospital (“NYP”) for HIPAA Privacy Rule violations.

Raleigh Orthopaedic

Following a breach notification report from Raleigh Orthopaedic in April 2013, OCR investigated and discovered that Raleigh Orthopaedic had improperly disclosed protected health information (“PHI”) to a third-party service provider without entering into a business associate agreement (“BAA”) with that service provider. Raleigh Orthopaedic had engaged the service provider to convert X-rays into electronic media and enabled the vendor to harvest the silver from the X-rays.

The resolution agreement requires Raleigh Orthopaedic to pay $750,000 million to OCR and enter into a Corrective Action Plan that requires the entity to provide OCR with a list of its business associates and copies of any relevant BAAs with such business associates. Raleigh Orthopaedic must also revise its policies and procedures to:

  • designate an official responsible for ensuring that Raleigh Orthopaedic enters into a BAA with each business associate prior to disclosing PHI to the business associate;
  • create a process to assess whether each current and future business relationship is with a business associate and enter into BAAs if required;
  • develop a process for negotiating and entering into BAAs;
  • create a standard template BAA;
  • retain documentation of the BAA for at least six years beyond the date when the business associate relationship is terminated; and
  • disclose to business associates only the minimum amount of PHI that is reasonably necessary for business associates to perform their duties.

In announcing the settlement with Raleigh Orthopaedic, OCR Director Jocelyn Samuels noted that “HIPAA’s obligation on covered entities to obtain business associate agreements is more than a mere check-the-box paperwork exercise.”

This is the second major OCR settlement in two months against a covered entity for improperly disclosing PHI to a third party without entering into a BAA. In March, North Memorial Care of Minnesota paid a $1.55 million settlement for similar violations.

NYP

The settlement with NYP resulted from a complaint received in January 2013 that NYP had allowed a film crew from the ABC medical reality TV show “NY Med” to film two patients without their authorization, including one patient who died in the emergency room during the filming. OCR’s investigation found that NYP had allowed ABC “virtually unfettered access” to the hospital that created “an environment where PHI could not be protected from impermissible disclosure to the ABC film crew and staff.”

In the resolution agreement, NYP agreed to pay a $2.2 million settlement to OCR and enter into a Corrective Action Plan that requires NYP to develop policies and procedures that contain:

  • a specific prohibition on the use or disclosure of PHI without patient authorization by NYP workforce members, agents and business associates to any person or entity planning, coordinating or engaging in photography, video recording or audio recording for non-medical related purposes;
  • a process for evaluating and approving authorizations requesting the disclosure of PHI by NYP;
  • identification of NYP personnel or representatives who workforce members, agents or business associates may contact in the event of any inquiry or concern regarding compliance with HIPAA in relation to these activities;
  • a requirement that all photography, video recording and audio recording conducted on NYP premises be actively monitored by appropriate NYP representatives for compliance with the Privacy Rule and NYP’s policies;
  • measures that address specific Privacy Rule provisions;
  • internal reporting mechanisms; and
  • the application of appropriate sanctions against members of NYP’s workforce, including supervisors and managers, who fail to comply with NYP’s policies and procedures.

In the press release accompanying the resolution agreement, OCR Director Jocelyn Samuels stated that “OCR will not permit covered entities to compromise their patients’ privacy by allowing news or television crews to film the patients without their authorization.” This is the second HIPAA enforcement action against NYP. In 2014, NYP paid $3.3 million and Columbia University paid $1.5 million as part of a collective settlement resulting from a breach of a shared data network that linked to patient information systems.

In connection with the settlement, OCR developed an FAQ addressing this issue that states that health care providers cannot invite media crews into treatment and other areas in which patients’ PHI will be accessible in any form unless the health care providers first obtain prior written authorization from each patient. The FAQ explicitly clarifies that subsequent masking or blurring of patient identities by the media (as had been done by ABC in the case of the patient who died on NY Med) was not sufficient “because the HIPAA Privacy Rule does not allow media access to the patients’ PHI, absent an authorization, in the first place.” The FAQ indicates that the HIPAA Privacy Rule does not, however, obligate health care providers to block the media from public waiting areas or areas where the public enters or exits the facility.