New York Times reports on privacy concerns about use of de-identified health information

The New York Times reported on Americans' growing concern regarding commercial use of their personal health information, especially the use of re-identified prescription drugs information for marketing purposes.  

The article points out correctly that the Recovery Act of 2009 (ARRA) included a few key changes to the present privacy regime, which would make it more difficult for pharmacies and data mining companies to use patient information for marketing or fundraising purposes.  While the new law (and the upcoming applicable HHS regulations sanctioned by ARRA) will close a few loopholes in the current medical privacy regime, data mining companies like IMS Health and Verispan do not seem to be overly worried about these new developments:

The law won’t shut down the medical data mining industry, but there will be more restrictions on using private information without patients’ consent and penalties for civil violations will be increased. Government agencies are still writing new regulations called for in the law.  <...>

IMS Health reported operating revenue of $1.05 billion in the first half of 2009, down 10.6 percent from the period a year earlier. [An IMS representative] said he did not expect growing awareness of privacy issues to affect the business.

The Times article also touches on a few other important areas of concern for privacy advocates:  the effect of widespread adoption and use of electronic health records (EHR's) and personal health records (PHR's) on privacy and security of patients' protected health information.  

Interestingly, the article notes that while "Microsoft and WebMD acknowledge that the privacy rules in the stimulus law apply to them," "Google says the law’s prohibitions do not apply to it, except for its duty to report any breaches of medical privacy."  According to a Google spokeswoman, "Google is bound by the privacy policy that people agree to when they sign up."  Right after the enactment of the Recovery Act, Google claimed that the additional privacy rules included in the ARRA did not apply to its PHR products.  However, Google acknowledged the applicability of ARRA's data breach notification requirements a few months thereafter.  This quote in the Times may reintroduce, if not underscore, Google's ambiguous attitude toward applicability of the new privacy and security rules.

"And You Thought a Prescription Was Private," The New York Times (August 9, 2009).

 

 

In the news: Personal Health Records edition

  • The Federal Trade Commission (FTC) issued interim regulations regarding breach notification requirements for PHR vendors, as mandated by the American Recovery and Reinvestment Act of 2009.  According to the FTC press release, aside from breach notification, the proposed rule also:

stipulates that if a service provider to one of these [PHR vendor] entities experiences a breach, it must notify the entity, which in turn must notify consumers of the breach. The proposed rule contains additional requirements governing the standard for what triggers the notice, as well as the timing, method, and content of notice. It also requires entities covered by the proposed rule to notify the FTC of any breaches. The FTC can then post information about the breaches on its Web site, and notify the Secretary of Health and Human Services.

             The full notice can be found here.

  • Mayo Clinic, in collaboration with Microsoft, launched its new personal health record (PHR) site on Tuesday April 21, 2009.  The Mayo Clinic Health Manager uses Microsoft's HealthVault system to store medical histories, test results, immunization files and other records from doctors' offices and hospital visits, along with data from home devices like heart rate monitors.  Anyone, not just Mayo Clinic patients, can open an account online; users can grant limited access to doctors, family members, and others to view the information contained in their PHR.  It would be very interesting to learn if the Mayo Clinic required Microsoft to sign a Business Associate Agreement, or if Microsoft would publicly acknowledge that their PHR product is subject to certain privacy and security rules under HIPAA.  ("Mayo Clinic backs new personal health record site", USA Today, April 21, 2009.)

 

  • Meanwhile, the Boston Globe raised serious doubts regarding the accuracy of patient information contained in Google Health's PHRs because "Google takes some information from insurance billing records that use broad and imprecise codes to describe patient treatment."  According to Dr. David Kibbe, a senior technology adviser to the American Academy of Family Physicians, "[claims] data is notoriously inaccurate and notoriously incomplete with respect to an expression of the problems a person has."   However, as Bob Evans of Global CIO Blog points out in an entry on this subject, is it better to have some information regarding a patient contained in a PHR, even if there is a good chance that such information can be wrong, or no information at all? ("Electronic Health Records Raise Doubt", The Boston Globe, April 13, 2009; "Google Health Records Reveal Grossly Inaccurate Info", Global CIO Blog (Bob Evans), April 13, 2009.)

 

Steve Fox on the new PHR privacy rules

Bob Brewin of NextGov interviewed Steve Fox regarding the new privacy rules for vendors of personal health records (PHRs), and the applicability of such rules not only to PHR vendors such as Google and Microsoft, but also to the less obvious "related entities", a group so broad it may include an iPhone app:

Steven Fox, a lawyer with Post & Schell in Washington who co-chairs the firm's data protection group, agreed that the rules cover Google and Microsoft but said he wished FTC had specifically identified the two companies in the proposed rules.

The rules cover about 200 vendors of personal health record systems and 500 "related entities, which include online medication or weight tracking programs, and 200 third-party providers that offer billing and data services.

The related entities category could include low-cost iPhone applications that would have to comply with the potentially costly breach notification process, Dixon said. An online guide lists "100 Fabulous iPhone Apps for Your Health and Fitness," and Fox said these applications would be covered by the breach notification rules if they exchange information with personal health records.

("Proposed breach notification rule would affect more health vendors", NextGov, April 16, 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.)