CVS & HHS: Partners in Compromising Your Privacy

On January 16, 2009, the Department of Health and Human Services (HHS) and CVS entered into a resolution agreement requiring CVS to pay a $2.25 million fine and implement a corrective action plan for “potential violations of the HIPAA [The Health Insurance Portability and Accountability Act of 1996] privacy rule.”  Why?  CVS had allegedly been placing prescription bottles and labels into dumpsters that were accessible to the public.  The bottles/labels contained protected health information (PHI), which CVS was required to safeguard under federal law.

Although HHS appears to regard the settlement as a success, given its prominence on the HIPAA enforcement section of HHS’s website, it is nothing of the sort.  The agreement provides that CVS “expressly den[ies] any violation of HIPAA or the Privacy Rule, and further den[ies] any wrongdoing,” while HHS does not concede that CVS is “in compliance with the Privacy Rule.”  HHS did agree with itself, however, releasing an FAQ (accompanying the press release) stating that under its Privacy and Security Rules: “covered entities are not permitted to simply abandon PHI or dispose of it in dumpsters or other containers that are accessible by the public or other unauthorized persons.”

Why is this old news important?  This week I had a prescription filled at my local CVS pharmacy in Livingston, New Jersey.  While standing at the pharmacy I noticed that all of the filled prescriptions were stored directly behind the counter in plain view of any customer.  Each prescription was inside a small bag to which a customer receipt was attached.  The receipts in the front row of the storage bins were readable from the counter.  The receipts contain protected health information (PHI) that is subject to the Privacy and Security Rules of HIPAA including:

1) Full name,

2) Address,

3) Telephone number,

4) Day and month of birth,

5) Drug name and dosage, and

6) Prescriber.

HHS maintains the authority for civil enforcement of violations of the Privacy and Security Rules promulgated pursuant to HIPAA.  So, why is it that CVS allows the public to view its customers’ PHI in violation of HIPAA even while still subject to the corrective action plan for its prior alleged violations?  Well, I asked the pharmacist on duty.  The pharmacist acknowledged that it was a problem that the PHI could be viewed from the counter.  However, CVS was expecting to remodel and “hopefully” the shelf would be placed farther away to render the PHI unreadable.  Upon requesting the contact information for CVS’s privacy officer, the pharmacist readily provided such information and stated that she would “appreciate” someone actually reporting the apparent violation.

HHS was recently provided with additional enforcement tools under the HITECH provisions of the American Recovery and Reinvestment Act of 2009.  Unfortunately, it does not appear that HHS is serious about enforcing its own regulations or resolution agreements; nor, if the flagrantly violative placement of prescriptions is indicative of mindset,  is CVS serious about HIPAA compliance.

RFID Tags for Nurses, then Everybody?

The recent City of Ontario v. Quon decision has had a mixed reception among privacy advocates. Though many are disappointed that employees’ privacy rights have once again been narrowed, some have discerned helpful dicta in the case. However, I worry that, whatever the drift of thought among swing justices, economic imperatives and cultural shifts will mean a lot less privacy in the workplace of the future. Health care in particular offers a few interesting bellwethers.

As an opinion piece by Theresa Brown explains, maintaining proper staffing levels in hospitals is becoming increasingly difficult. Surveillance systems are offering one way to address the problem; work can be performed more intensively and efficiently as it is recorded and studied. But such monitoring has many troubling implications, according to Torin Monahan (in his excellent book, Surveillance in a Time of Insecurity):

The tracking of people [via Radio Frequency Identification Tags] represents a . . . mechanism of surveillance and social control in hospital settings. This includes the tagging of patients and hospital staff. . . . When administrators demand the tagging of nurses themselves, the level of surveillance can become oppressive. . . . [because nurses face] labor intensification, job insecurity, undesired scrutiny, and privacy loss. . . . To date, such efforts at top-down micromanagement of staff by means of RFID have met with resistance. . . . One desired feature for nurses and others is an ‘off’ switch on each RFID badge so that they can take breaks without subjecting themselves to remote tracking. (122)

Like the “nannycam” employed by many a wary parent, the nurse-cam may be seen as a way to protect the vulnerable. It may also increase the accuracy of evidence in malpractice cases. On the other hand, inserting a tireless electronic eye to monitor what is already an extremely stressful job may create many unintended consequences, or deter people from going into nursing altogether. Even advocates of pervasive surveillance recognize these difficulties.

The increasing pressure to monitor what happens inside hospitals reminds me of a recent article by Thomas Goetz in Wired (no link yet) on Google co-founder Sergey Brin’s quest to find a cure for Parkinson’s disease. As Goetz describes it, a new form of “high-speed science” depends on rapid accumulation of as much data as possible:

In Brin’s way of thinking, each of our lives is a potential contribution to scientific insight. We all go about our days, making choices, eating things, taking medications, doing things—generating what is inelegantly called data exhaust. . . . With contemporary computing power, that data can be tracked and analyzed. “Any experience that we have or drug that we may take, all those things are individual pieces of information. Individually, they’re worthless, they’re anecdotal. But taken together they can be very powerful.” In computer science, the process of mining such large data sets for useful associations is known as a market-basket analysis.

Goetz has promoted this as a new way to “do science in the petabyte age.”
Read more

Patient Safety and Quality Improvement: Civil Money Penalty Inflation Adjustment

By: Constantina Koulosousas

The Patient Safety and Quality Improvement Rule was amended, effective November 23, 2009, by the Department of Health and Human Services to adjust the maximum civil money penalty amount for violations of the confidentiality provisions. The amount was adjusted for inflation to comply with the Federal Civil Penalties Inflation Adjustment Act of 1990. This amendment was carried out through direct final rule making, as HHS expected no significant adverse comments to the rule.

The Patient Safety and Quality Improvement Act of 2005 created a voluntary program for health care providers to share what is known as “patient safety work product” (PSWP), or any information relating to patient safety events and concerns with each other and Patient Safety Organizations (PSOs). The Department of Health and Human Services is required to maintain a listing of all PSOs.

The Act amended Title IX of the Public Health Service Act for the purpose of improving patient safety and quality of care. As with attorney work product, this information is privileged and confidential. While the program may be voluntary, a knowing or reckless violation of the confidentiality requirements of the Act can result in a civil money penalty of up to $10,000 for each violation, as assessed by the Office for Civil Rights.

The deterrence effect of the civil money penalties had been reduced by inflation. This caused Congress to enact the Inflation Adjustment Act. This Act requires Federal agencies to issue regulations adjusting each civil money penalty found within the Public Health Service Act within their jurisdiction, for inflation. The agencies are required to issue these regulations at least once every four years from July 29, 2005, the date of its enactment. The inflation amount is adjusted through a three-step process.

First, the agency must calculate an increase in the penalty amount by a “cost-of-living adjustment.” “Cost-of-living adjustment” is defined in the act as the percentage for each civil monetary penalty by which the Consumer Price Index for the month of June of the calendar year preceding the adjustment, exceeds the Consumer Price Index for the month of June of the calendar year in which the amount of such civil money penalty was last set or adjusted pursuant to law.

Second, the amount of increase must be rounded based on the size of the penalty as set forth in section 5(a) of the Act. Since the penalty in this case is $10,000, the increase is $1,000, making the final maximum penalty amount $11,000. Finally, the third step requires that a first adjustment be limited to 10 percent of the penalty amount. Accordingly, an $11,000 adjusted penalty is appropriate.

One great benefit of the Act is to make sure that the penalties assessed for such violations provide adequate deterrence to potential violators. This is done by periodically increasing the violation amount to account for inflation over time. Especially now in the wake of the massive health care reform and improvements in the use of Electronic Health Records, it is important to ensure patients that their personal health information remains confidential and that a breach of this confidentiality requirement will result in steep monetary penalties.

On the contrary, many may argue that the increase in the penalty amount is not adequate. Since the Act imposes a 10% cap in addition to a standard chart for calculating the inflation, it may not always be completely in sync with the current economic environment. Further, these penalty amounts are only updated every four years, which leaves a significant gap in time.

Additionally, the slight increase in money penalties assessed will not do much to comfort patients that their health information is protected and confidential. Once the information gets out, there is no amount of money assessed as a violation that can remedy the breach and the damage which may have already been done. Further, to many of the entities involved in such violations, a $10,000 penalty may seem like an insignificant slap on the wrist.

The Act only punishes a “knowing or reckless” violation of the confidentiality provisions, so breaches that occur unintentionally will not subject physicians or PSOs to liability. This mental state requirement is especially important as electronic health record software gets ironed-out, to get rid of any technical issues or glitches that may arise in the course of implementing such a national electronic system.

Conversely, the “knowing or reckless” standard may pose some difficulties enforcing liability under the Act, as it may not always be easy to prove that the confidentiality breach was done with such a state of mind, or even where the disclosure came from.

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

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

Acronym	Phrase	General Definition (see 160.103 for regulatory language)
PHI	Protected Health Information	Any oral or recorded information relating to any past, present, or future physical or mental health of an individual, provision of healthcare to the individual, or the payment for the healthcare of that individual.
CE	Covered Entity	A group of entities whose use, disclosure, and protection of PHI is regulated by HIPAA and HITECH. CEs are comprised of: 1) Health care provider (e.g. physicians) that submit transactions electronically. 2) Health care plans (e.g. HMOs) 3) Health care clearinghouses (which are public or private entities, including a billing service, repricing company, community health management information system, etc… that processes or facilitates the processing of health information received from another entity in nonstandard form into standard form, or from standard form to non-standard form.
BA	Business Associate	Individuals or organizations performing an activity involving the use or disclosure of PHI on behalf of the CE. BAs can include attorneys, accountants, shredding companies, billing companies, or any other person or organization that is not a CE but which is accessing a CE’s PHI.
EHR	Electronic Health Record	An electronic record of patient care comprised of information about the delivery of care, including demographic information, medications, diagnoses, etc.
PHR	Personal Health Record	An electronic record of patient care comprised of much of the same information that an EHR is comprised of, but which is created and maintained by the individual (usually a patient) as opposed to a provider. Prominent examples are Google Health and Microsoft HealthVault

d

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?”

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.”