HIPAA, The HITECH Act, and How Google May Still Be Able to Distribute, and Profit From, Your Personal Health Info

Photo by Jonathunder

Below I will explore what seems to be a gaping hole in the HITECH Act. However, as with any new legislation, it is often necessary to reexamine the laws that preceded it, which in this case is HIPAA.  This is particularly true given that the HITECH Act does not replace HIPAA. Rather, it provides–amongst other things–additional security and privacy safeguards with respect to health information. To that extent,  at least a cursory reexamination of HIPAA is required before understanding HITECH and the importance of comprehensive legislation.

HIPAA was a product of the 1990’s–an era triggering nostalgic memories of grunge music  for some, and the (in)famous Macarena dance for others. For a large part of this period, the Internet was accessed by a handful of tech savvy individuals who dialed into services like CompuServ, Prodigy, and AOL.  It was during this transition that Congress felt the need to make health insurance more portable, as well as standardize the variegated electronic systems that were conducting nonstandard healthcare-related transactions. There was a concomitant concern that health information needed better protection. Thus, in 1996 Congress adopted the Health Insurance Portability and Accountability Act (HIPAA), providing HHS with the responsibility to enforce it. However, the regulation enforcing privacy and security of health information would not be implemented until years later.

HIPAA’s Privacy Rule, which describes the appropriate use and disclosure of certain health information, came into force on April 14th, 2001, updated in 2002, with compliance required by April of 2003. The Security Rule, which establishes the policies and best practices for securing health information, came into force in 2003. Thus, the Privacy and Security Rules (referred to below as HIPAA) came to life in a period of technological transition. New technologies like residential broadband Internet access and Wi-Fi networks were becoming the norm. Electronic Health Record (EHR) systems had been developed, but had only marginal penetration within certain academic medical centers and government entities. Consequently, the threats to patient privacy from early EHRs was much smaller than it is today, since these systems were not widespread and did not often share data over disparate regions. Thus, access to the systems was not necessarily available outside of the intranets where the servers were located.

Acronyms of HIPAA & HITECH

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Given the historical context of HIPAA’s passage, it is easy to appreciate HIPAA’s missteps in not specifically  focusing on EHRs or PHRs.  Rather, HIPAA regulates protected health information at a broader level, focusing primarily on the “use and disclosure” of PHI by CEs, and the best practices and policies for securing the PHI itself.   To be fair, the Security Rule does focus on PHI that is stored and transmitted electronically. However, even the most stringent best practices and policies are useless if the corresponding privacy regulations are inadequate.

But the times they are a-changin’–sort of.

Buried on page 112 of the American Recovery and Reinvestment Act (ARRA)–also known as the Stimulus Bill–is Title VIII of the bill, known as the Health Information Technology for Economic and Clinical Health Act, or more commonly, the HITECH Act. One (of the many) purposes of the HITECH Act is to fill in the gaps that have emerged since the Privacy and Security rules came into force.  But like before, we are in a transition period. Whereas HIPAA’s passage coincided with a period of generalized transition towards digital information, HITECH has coincided with its own transition: the implementation of personal health records (PHRs). Unfortunately, the current HITECH Bill and regulations have serious flaws in how they protect patient information stored in PHRs. However, before discussing the problems, it is only fair to discuss the benefits to privacy and security that HITECH’s passage has provided.

Specifically, HITECH introduces breach notification requirements. HITECH’s provisions govern the procedures which CEs and BAs must follow if health information has been compromised. HITECH also empowers the FTC to promulgate regulations pertaining to the notification procedures of PHR vendors (as well as those who offer services to PHR vendors). The FTC’s proposed breach notification requirements can be found here. Thus, CEs, BAs, and PHR vendors are, for the first time, required by law to notify individuals if their unsecured PHI has been accessed by unauthorized individuals.  Surprisingly, this was not required under HIPAA. CEs were obligated to notify individuals only insofar as the CEs were required by HIPAA to mitigate damages. But now, with the passage of HITECH, breach notification is no longer amorphous, but is spelled out in detail in HITECH’s regulations.

Additionally, HITECH requires BAs to abide by many of the same privacy and security requirements that CEs have had to abide by. Before HITECH, a BA, such as an attorney reviewing the PHI of a CE, was required to sign an agreement promising to protect the PHI that they were accessing, but were not themselves regulated by HIPAA. Thus, BAs had only contractual liability to the CE if the BA violated the rules of the agreement. On the other hand, if a CE violated HIPAA, it was subject to specific penalties and fines by the government.

Under HITECH, BAs must now comply with much of the Privacy and Security Rule, and face many of the same penalties and fines if they violate HIPAA regulations. That is, BAs are now accountable to the government if they improperly use or disclose PHI, or fail to adequately secure PHI.

HITECH also offers other benefits, such as increased enforcement of violations, a strengthening of the requirement that only the minimum necessary information is disclosed to other CEs or BAs, a more thorough framework of accounting for uses and disclosures, as well as a certain prohibitions on the sale of PHI.

The last benefit of HITECH–the prohibition on the sale of PHI–is a perfect springboard for discussing the potential pitfalls of HITECH. The benefits of HITECH may well be sufficient to shore up HIPAA’s gaps when it comes to regulating CEs and BAs. However, as HITECH’s regulatory language makes clear, there remains a gaping hole:

(d) Prohibition on Sale of Electronic Health Records or Protected Health Information-

(1) IN GENERAL- Except as provided in paragraph (2), a covered entity or business associate shall not directly or indirectly receive remuneration in exchange for any protected health information of an individual unless the covered entity obtained from the individual, in accordance with section 164.508 of title 45, Code of Federal Regulations, a valid authorization

The emphasis is added to underscore that PHRs are not included in this provision. There is no corresponding provisions in the FTC’s proposed regulations which concern breach notification. The upshot of this is that, as of the date of this posting, PHR services like Google Health and Microsoft HealthVault are not subject to this prohibition, nor is there a provision in HITECH mandating that PHRs comply with HIPAA’s Privacy and Security Rule. Therefore, PHR vendors can use, disclose–and possibly even sell–an individual’s health information outside of the HIPAA and HITECH regulations. This problem underscores a larger issue: PHRs are not regulated by HIPAA, and only regulated by HITECH insofar as the FTC’s interim rule requires certain breach notification procedures. Read more

LoJacking Grandma and “Reality Mining,” or “Daddy, What was Anonymity?”

photo by mrsmartino via flickr

Mark Heftler, a geriatric care manager who is slated to begin study at Seton Hall Law in the Fall, has written an interesting article on RFID (Radio Frequency Identification) and its potential usage as a means of  early diagnosis of dementia among the elderly. Researchers at the University of South Florida have developed and tested an RFID technology which assesses the walking patterns of those which it monitors.

By monitoring the movements of the elderly within geriatric facilities, “the researchers hope to be able to diagnose the onset Alzheimer’s in their patients. Sudden veers, long pauses, and a tendency to wander are all indicators of dementia.”

As MIT’s Technology Review notes, “Drugs that are currently available can only slow the progression of related diseases, so the earlier dementia is caught, the better a patient’s treatment will be.”

Technology Review also notes, “In particular, dementia increases the risk of injury caused by a fall… ‘That’s a huge problem for assisted-living facilities,’” said  William Kearns, an assistant professor who researches aging and mental health at USF.

Not Just Grandma

Although one can readily see the positive cost/benefit and quality of life implications of warding off the falls of the elderly, as Frank Pasquale recently noted on both this blog and Concurring Opinions, the proliferation of “personal” electronic data is not without its danger.

The Technology Review article provides a link to another article which points out that RFID technology is also being harnessed to gather social networking information through what is referred to as “reality mining,”

“…a field that Tanzee­m Choudhury pioneered as a PhD student at the MIT Media Lab. Working at Intel after graduation, she created a pager-size sensor pack–loaded with software plus microphones, accelerometers, and other data-gatherin­g devices–to collect and analyze data about human interactions and activity. For instance, by processing verbal utterances, she can identify the most influential people in a social network.

Now an assistant professor of computer science at Dartmouth, Choudhury is conducting experiments with the sensor-laden iPhone. Within a few years, she says, simple versions of her software could be available for cell phones.”