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A New Year’s Resolution (and Corrective Action Plan) from OCR: Physician Practice Cited for HIPAA Violations

Written by:  Dianne Bourque

The Office for Civil Rights (OCR) is closing out 2013 with a reminder of the importance of an effective HIPAA compliance program. On December 26, 2013, OCR announced a resolution agreement with a Massachusetts physician practice to settle violations of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) privacy, security and breach notification rules. The practice, Adult and Pediatric Dermatology, P.C., of Concord Massachusetts (AP Derm) agreed to pay a $150,000 fine and enter into a corrective action plan to address deficiencies in its HIPAA compliance program. 

This enforcement was prompted by the loss of an unencrypted thumb drive containing the protected health information (PHI) of 2200 Mohs surgery patients. The thumb drive was stolen from the car of one of the practice’s employees and never recovered.  OCR began its investigation of AP Derm within one month of AP Derm’s breach report to OCR and among other things, found that AP Derm failed to conduct a thorough and accurate risk assessment until almost one year following the breach. Additionally, AP Derm failed to adopt written breach notification policies and procedures and to train its workforce on breach notification requirements.

In addition to paying $150,000 to OCR to settle the matter, AP Derm agreed to a Corrective Action Plan, requiring, among other things, (i) a comprehensive, enterprise wide, risk assessment encompassing all electronic systems and media; and (ii) a comprehensive review and updates to its policies and procedures, all of which must be submitted to OCR for review.  AP Derm must also report all potential HIPAA violations by its workforce to OCR for review (not just violations that are reportable under HIPAA’s breach notification regulations).   

Covered entities and business associates would be well advised to take stock of the following as we head into a new year:

  • It is critical to regularly conduct and document comprehensive risk assessments for all PHI, especially PHI in electronic form.
  • Don’t wait until after a breach to conduct a risk assessment.
  • HIPAA policies and procedures must be complete, current and actually implemented (through training, for example).
  • Portable media containing PHI should never be unencrypted, because it will ALWAYS be stolen or lost.
  • Self-reported breaches can lead to enforcement. 

OCR’s press release regarding this enforcement action and other enforcement information can be found here

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Theresa advises clients on all aspects of the pharmaceutical supply chain, including counseling industry stakeholders on a range of business, legal, transactional, and compliance matters. She provides clients with strategic counseling and creative business modeling that considers legal restrictions and regulatory risk in light of innovation and business goals.