FTC Issues Final Breach Notification Rule for Electronic Health Information

Pursuant to the American Recovery and Reinvestment Act of 2009 (ARRA), the Federal Trade Commission (FTC) issued the final rule regarding notification requirements for breaches of electronic health information by vendors of personal health records and certain affiliated entities:

The rule applies to both vendors of personal health records – which provide online repositories that people can use to keep track of their health information – and entities that offer third-party applications for personal health records. These applications could include, for example, devices such as blood pressure cuffs or pedometers whose readings consumers can upload into their personal health records. Consumers may benefit by using these innovations, but only if they are confident that their health information is secure and confidential.


The Final Rule requires vendors of personal health records and related entities to notify consumers following a breach involving unsecured information. In addition, if a service provider to one of these entities has a breach, it must notify the entity, which in turn must notify consumers. The Final Rule also specifies the timing, method, and content of notification, and in the case of certain breaches involving 500 or more people, requires notice to the media. Entities covered by the rule must notify the FTC, and they may use a standard form, which can be found along with additional information about the rule at www.ftc.gov/healthbreach.

You can find the full text of the rule here.

"FTC Issues Final Breach Notification Rule for Electronic Health Information," FTC Press Release (August 17, 2009).

In the news: CVS and Google; Connect Open Source Software; and more

  • CVS pharmacy customers now have the ability to download their prescription and medication histories to Google Health accounts after CVS and Google expanded their partnership.  Patients at CVS' walk-in MinuteClinics are also able to add summaries of their visits to their Google Health accounts.  It would be interesting to find out if CVS and Google ever executed a Business Associate Agreement.  After the enactment of the HITECH Act, Google famously maintained that its personal health records product is not a subject to the new legislation and certain privacy and security provisions under HIPAA.  ("CVS-Google Health pact now includes drugstores", AP, April 6, 2009.)
  • The federal government released Connect, and open source software which allows public and private entities to share health information via the National Health Information Network.  The source code is free to download (the code and its documentation are available here), but organizations choosing to acquire and use this product will be responsible for costs associated with the installation and maintenance of Connect.  The Social Security Administration, Department of Defense, Veterans Affairs, and the CDC are among the many government agencies using this software for health information exchange already.  ("NHIN software released to open-source community", Government Health IT, April 7, 2009.)



  • This Business Week article analyzes the various data privacy and security concerns facing health care providers and patients alike.  ("Putting Patient Privacy in Peril?", Business Week, April 6, 2009.)
  • The New York Times reports that New York-Presbyterian Hospital became "the first large institution to move beyond the pilot stage this week as it begins to offer consumer-controlled health records for patients... New York-Presbyterian has been working with Microsoft for more than a year, not only on technical matters but also ease-of-use concerns with patients. The introduction will be gradual, beginning with heart patients, who will be told of the potential benefits of personal health records when they visit a New York-Presbyterian hospital or outpatient clinics."  Once again, it would be very interesting to find out if NYB and Microsoft signed a Business Associate Agreement, or if Microsoft acknowledged whether it is now subject to certain privacy and security provisions under HIPAA.  ("A Hospital Is Offering Digital Records", New York Times, April 5, 2009.)