Monday, April 16, 2012

Privacy and Security Considerations for Emerging Health Information Exchanges: Notes from Utah and New York

Earlier this month the Utah Department of Health issued a press release describing a cyber attack on its server, in which hackers removed information for approximately 780,000 individuals. According the Department of Health, the information contained personal records of individuals within the state, including Medicaid and Children’s Health Insurance Plan recipients.

Permutations of this scenario- whether hacking into a computer server, losing a USB key, or a stolen laptop- are all familiar news headlines announcing a security breach of individuals' health and personal information. Human error and human opportunism make it likely that we will continue to see such information breaches in the future, despite steps to mitigate potential security threats.

As states begin to develop legislation and promulgate rules to govern their electronic health information exchanges (HIE), they should carefully balance residual security and privacy risks with the potential promises of a functional HIE when determining policies relating to how a system enters an individual’s electronic health record (EHR) and what portion of the EHR the state enters into the HIE.

Last month, the New York Civil Liberties Union (NYCLU) issued a report, Protecting Patient Privacy: Strategies for Regulating Electronic Health Records Exchange, which articulated numerous privacy, security, and functional concerns with the state’s emerging HIE. Currently, New York employs a blanket consent procedure for record access and enrolls patients of participating providers into the state's regional health information organizations (RHIOs). 

Among numerous concerns, NYCLU’s Report highlights two distinct issues with this approach:

(1) New York does not provide a mechanism for patients to limit sharing stigmatizing sensitive information such as substance abuse records or mental health treatment if they consent to participate in the exchange; and

(2) Although physicians must obtain consent to view patient information in the exchange, participating providers enter patient medical information into the exchange without patient consent and patients cannot opt-out of the record locator system.

The Office of the National Coordinator for Health Information Technology’s HIT Policy Committee has asserted that a form of granular control over health data can protect the confidentiality of narrow categories of sensitive health information while fostering patient autonomy, promoting trust in medical providers, and building confidence in the growing use of HIT. Although too much data segmentation or exclusion options could confuse patients and undermine the purpose of the HIE as a comprehensive record system, some groups, such as the NYCLU, argue that existing state law requires the capacity for granular control over statutorily identified categories of sensitive medical information. This assertion serves as a reminder that each state contains varied protected categories of sensitive medical information as well as different standards defining additional measures relating to sharing and accessing this information. Earlier this month, the New York Department of Health and the New York eHealth Collaborative established the State Health Information Network of New York Policy Committee to examine these and numerous other concerns over the state’s current policies and procedures governing the exchange.

Patients may also be wary of the security of their identifying records available in the HIE registry system, as a breach could reveal both personal information and the entirety of the patient’s medical records that providers have entered into the HIE. A breach of the HIE would not only invade the patient’s abstract notion of privacy over sensitive information, but could also expose the patient to quantifiable concrete harms such as identity theft, fraud, and the costs associated with investigation and mitigation.

Some victims involved in major medical security breaches have asserted that once information such as social security numbers, patient demographic information, and medical records are accessible in a breach, victims face an imminent and continuing risk arising from the security breach itself regardless of whether an outside party has used the information. Currently, some courts have ruled that even where a third party steals media containing patient information, if the victims cannot prove that a third party actually accessed or used the information, then claims for future financial harm arising from a security breach are insufficient to constitute an actionable injury. To address these legitimate concerns, jurisprudence should evolve with the recognition that potential third party use of this information may be difficult to identify and costly to monitor. Further, months may pass following the initial breach before victims notice fraudulent activity, such as in the substantial TRICARE data breach.

State legislatures should remain cognizant of both patients' desire for privacy and their corresponding wish to limit access to sensitive medical information as well as security concerns from both accidental as well as intentional breaches of patient information during the initiation or expansion of the state's HIE .
-Katherine Drabiak-Syed

Friday, March 2, 2012

Community Roundtable, April 9: Biobanking 101: What are they and how can the public participate?

If you're in central Indiana this coming April, you might want to attend a community event on biobanks. PredictER's Eric M. Meslin will be directing a roundtable discussion on biobanks on April 9 from 11:30 a.m. to 1 p.m. at the Indiana Historical Society, 450 W. Ohio St.

This event is sponsored by The Fairbanks Institute for Healthy Communities and the Indiana Clinical and Translational Sciences Institute Community Health Engagement Program.

Eric M. Meslin, PhD, is director of IU Center for Bioethics and associate dean for bioethics at the IU School of Medicine. He also co-directs the IU Center for Law, Ethics and Applied Research in Health Information and directs the Indiana CTSI Bioethics and Subject Advocacy Program.

Parking is free and lunch will be provided. To register, visit redcap.uits.iu.edu/surveys/?s=g6M4FP.

For more information, see the event flier.

Tuesday, December 13, 2011

The End of Embryonic Stem Cell Research in Europe? The European Court of Justice Decision, Case C-34/10, October 18, 2011

The European Court of Justice (“ECJ”) ruled in the case Brüstle v. Greenpeace (Case C-34/10) brought up by Greenpeace seeking annulment of the German patent – Patent No. DE19756864C1 – held by Mr. Brüstle concerning isolated and purified neural precursor cells, processes for their production from embryonic stem cells and the use of neural precursor cells for the treatment of neural defects. The main focus of the decision is the interpretation of Article 6(2)(c) of Directive 98/44/EC (1998 OJL (L213) 13-18) of the European Parliament and of the Council of 6 July 1998 on the legal protection of biotechnological inventions.

The German Federal Patent Court (Bundespatentgericht, “BPatG”) ruled on December 5, 2006, Case 3 Ni 42/04, on the basis of Paragraph 22(1) German Patent Protection Act (“PatG”) in conjunction with Paragraph 21 Subsection 1 Point 1 PatG in conjunction with Paragraph 2 Subsection 2 Point 3 PatG, that the patent at issue is invalid in so far as it covers precursor cells obtained from human embryonic stem cells and processes for the production of those precursor cells. The court held that the patent also violates the German Embryonic Protection Act (“ESchG”), which prohibits research with human embryos. Mr. Brüstle appealed against the judgment to the German Federal Court of Justice (Bundesgerichtshof, “BGH”), December 17, 2009, Case Xa ZR 58/07.

In accordance with the guiding principles of European Union Law, the national law of the Member States must be interpreted in terms of the rules and regulations set by the European Union; the court held that the outcome of the application for the annulment of the patent de-pends on the interpretation of Article 6 of the Directive, which is implemented in the PatG as well as the ESchG. Thus, the BGH referred specific questions to the ECJ and requested a preliminary ruling regarding:

1. the interpretation of the term “human embryos” in Article 6(2)(c) of the Directive;
2. the interpretation of the expression “uses of human embryos for industrial or commercial purposes” and the question if this especially includes the use for the purposes of scientific research;
3. and if an invention is unpatentable even if the use of human embryos does not form part of the technical teaching claimed with the patent, but whose production necessi-tates the prior destruction of human embryos. See, in detail: Bundesgerichtshof [BGH] [German Federal Court of Justice], December 17, 2009, Case Xa ZR 58/07; ECJ, October 18, 2011, Case C-34/10, para. 23.

The Concept of Human Embryo

Because the Directive lacks a definition of the term “embryo” and after considering the preamble and the scope of the directive, the court ruled:
"any human ovum after fertilisation, any nonfertilised human ovum into which the cell nucleus from a mature human cell has been transplanted, and any nonfertilised human ovum whose division and further development have been stimulated by parthenogenesis constitute[s] a human embryo" (Case C-34/10, para. 53);

"stem cells obtained from a human embryo at the blastocyst stage, […] whether they are capable of commencing the process of development of a human being, […] are included within the concept of human embryo” (Case C-34/10, para. 37).

Human Embryos for Scientific Research

The Directive is limited to the patentability of biotechnological inventions; it does not regulate the use of human embryos in the context of scientific research directly. Considering Recital 14 of the Directive, the court ruled:
"[the] use of human embryos for industrial or commercial purposes' within the meaning of Article 6(2)(c) of the Directive also covers use for purposes of scientific research" and are not patentable;

"only use[s] for therapeutic or diagnostic purposes which [are] applied to the human embryo and are useful to it [are] patentable". (Case C-34/10, para. 46)

Inventions Based on the Destruction of Human Embryos

Taking into account that a human embryo is destroyed when a stem cell is removed during the blastocyst stage, for example, in the production of neural precursor cells (Case C-34/10, para. 48), the court held that when the destruction occurs at a stage long before the implementation of the invention it is irrelevant (Case C-34/10, para. 49). Therefore, the court ruled:
"an invention must be regarded as unpatentable, even if the claims of the patent do not concern the use of human embryos, where the implementation of the invention requires the destruction of human embryos" (Case C-34/10, para. 49);

"the fact that destruction may occur at a stage long before the implementation of the invention, as in the case of the production of embryonic stem cells from a lineage of stem cells the mere production of which implied the destruction of human embryos is, in that regard, irrelevant" (Case C-34/10, para. 49).

This recent decision may do more to impede the progress of embryonic stem cell research in Europe than any inherent limits in the state of science itself. The court used a very broad definition of the term “embryo” without using any scientific reference points. With its definition of “embryo” the court included nearly all possible stages in the development. Although, the court recognized that non-fertilized ova are incapable of developing into a human being, it nonetheless placed them on the same level as an embryo. The implications of this decision are widespread in Europe; the decision is binding and cannot be appealed. It remains to be seen how the German courts and legislature, as well as those of the other Member States will react and comply.

-- Bianca Buechner, Ph.D., LL.M. Candidate
Indiana University Robert H. McKinney School of Law

Friday, November 11, 2011

The Next Ethical Problem in Translational Science: Crossing the "Policy Valley of Death". Eric M. Meslin, PhD. Nov. 14th, 2011

Join us Monday, November 14th at 3:00 p.m. for a presentation by Eric M. Meslin, The Next Ethical Problem in Translational Science: Crossing the "Policy Valley of Death". Location: Indiana University Center for Bioethics, 410 West 10th Street, Suite 3100, Indianapolis, IN.

This presentation will make the case that there are two gaps to be bridged in successful translational science, one between "the bench and the bedside" and another between the "lab and legislature." Without a sturdy bridge from the lab to the legislature, advances in translational science could be lost to the "policy valley of death."

Thursday, December 16, 2010

Second Lawsuit Against Texas Department of State Health Services Over Alleged Misuse of Newborn Blood Spots


Last week parents in Texas filed a lawsuit against Texas Department of State Health Services (TDSHS) relating to the storage and distribution of their child’s newborn blood spots (NBS). Emerging approximately a year after a settlement over the NBS last December, this news headline looked like déjà vu. The new lawsuit focuses on the gaps of last December’s settlement agreement of the prior case against TDSHS and facts discovered after the settlement.

This separate class action lawsuit led by parent Jeffrey Higgins takes issue with how and for what purposes TDSHS shared the NBS. During the Beleno suit last year, the Beleno plaintiffs repeatedly asked TDSHS with whom they were sharing the NBS and for what purposes. During each of those discussions in the spring of 2009 and before a House Public Health Committee Hearing, TDSHS maintained it shared the NBS for the purpose of public health research but disclosed minimal additional information.

However, a large number of NBS were not used for public health research and this information did not become public until after the settlement. TDSHS numerous NBS to for-profit entities such as Perkin Elmer and bioMerieux in exchange for laboratory supplies. TDSHS only fully shared the extent of how many samples it shared, with what entities it shared the samples, and for what reasons on its website as part of the settlement agreement.

Perhaps most shocking, however, was that TDSHS sent 800 NBS to the Armed Forces Institute of Pathology (AFIP) to build a mitochondrial DNA (mtDNA) registry. AFIP designed this registry as a forensics tool to identify missing persons, solve old crimes, and eventually, share the samples internationally for law enforcement and anti-terrorism efforts. An investigative report that discovered this project surfaced in the media months after the settlement agreement in the Beleno case. [Read our commentary on the mtDNA registry here.]

The Higgins lawsuit focuses on TDSHS’s lack of transparency during the Beleno settlement discussions and alleges that TDSHS intentionally withheld pertinent information that would have substantially altered that case’s discussions and outcome. Similar to the Beleno complaint, Higgins argues that selling or trading the NBS to outside corporations and giving the NBS to the AFIP to build the mtDNA registry rises to Constitutional violations.

  1. First, he maintains that taking his child’s NBS and sharing it with outside entities without consent constitutes a violation of his child’s right against seizure of deeply private genetic information.
  2. Second, he asserts that sharing his child’s NBS without consent constitutes a violation of privacy.

The Higgins complaint emphasizes TDSHS’s alleged failure to disclose significant facts and communicates the plaintiffs’ concerns about misuse of the hundreds of thousands of NBS that were sent to outside entities. Importantly, the settlement agreement last December 2009 only provided that TDSHS was required to destroy the NBS in its possession. This meant the settlement had no legal effect on what other entities did with the NBS they received from TDSHS.

Accordingly, the complaint asks the court for injunctive relief to stop TDSHS from sharing the NBS with outside entities without consent in the future and for the court to order outside entities that previously received the NBS to destroy the blood samples and any associated data they may have. The first request is significant because it directly challenges the current law in Texas that requires parents to opt-out if they do not want TDSHS to use and share their child’s NBS for research and instead argues that TDSHS must actually obtain consent.

Carrie Williams, spokesperson for TDSHS, maintains that these issues have already been resolved and stated that the Texas Civil Rights Project representing the plaintiffs merely wants “to double dip back into this issue with baseless assertions.”

Despite Williams’ response, mounting evidence does show a startling lack of transparency on the part of TDSHS. Furthermore, if the case goes before the same judge that heard the Beleno case, the result may have a substantial impact. As with other highly unexpected court rulings recently relating to gene patents and embryonic stem cell funding, this case could potentially constitute a monumental turn for whether it is acceptable to collect blood to use and share for research by the opt-out method. In the last Beleno case, Judge Biery in the Western District of Texas denied TDSHS’s motion to dismiss, meaning the court planned to hear the merits of the those Constitutional issues. However, before the parties argued the merits they arrived at a settlement agreement, taking the question out of the courtroom.

The case is still in its infancy, and TDSHS has yet to file a response to Higgins’ complaint. As the case progresses and if Judge Biery eventually hears the merits, we may see another highly surprising court ruling impacting future collection of blood for research purposes.


--Katherine Drabiak-Syed


Timeline of Events


  • May 2003: TDSHS sends 200 NBS to the Armed Forces Institute of Pathology to build their mtDNA registry.
  • December 2006- December 2007: TDSHS sends a total of 3600 NBS to bioMerieux in exchange for laboratory supplies.
  • May 2007: TDSHS sends 600 NBS to the Armed Forces Institute of Pathology to build their mtDNA registry.

  • March 2009: Parents led by Andrea Beleno (Beleno plaintiffs) file a complaint against TDSHS.

  • March 2009: Beleno plaintiffs question where TDSHS has sent the NBS and for what purposes. TDSHS maintains they use and share the NBS for public health research.

  • December 2009: Beleno plaintiffs and TDSHS settle the lawsuit out of court.

  • March 2010: An investigative report reveals TDSHS sent a total of 800 NBS to the AFIP’s mtDNA registry. TDSHS spokesperson, Carrie Williams, still asserts that this project falls within the category of “public health research.”
  • December 2010: Parents led by Jeffrey Higgins file a complaint against TDSHS.



Read past PredictER News coverage relating to newborn blood spots here:


Oklahoma Legislature Requires Express Consent to Retain Newborn Blood Spots

Transparency of Texas' NBS Transfer and Reassessing Evasive Statutory Interpretation

Newborn Blood Spot Banking in Canada

Minnesota Judge's Dismissal of Newborn Blood Spot Case Misses the Mark

Newborn Blood Spot Litigation Continues in Minnesota and Texas

Critiquing HHS's Summary Recommendations on Newborn Blood Spots: Opt-Out is Not Optimal

Newborn Screening: an Update on Minnesota

Minnesota and Genetic Privacy: Why the Rule of Law is Good for Research



See also:


Jere Odell. Newborn Blood Spots, Biobanks, and the Law: Research Ethics in the News. Indiana Bioethics. February 2010.

Katherine Drabiak-Syed. Newborn blood spot banking: approaches to consent. PredictER Law and Policy Update.Indiana University Center for Bioethics. March 12, 2010.



Wednesday, November 10, 2010

Mercy Health Plan's Medical Data Security Breach Should Inform OCR's Harm Standard

A recent medical data security breach occurring in Keystone Mercy Health Plan and AmeriHealth Mercy Health Plan in Philadelphia lends support to removing the harm threshold written into the Interim Final Rule of HIPAA and the HITECH Act before promulgating the Final Rule. In August of 2009, the Office of Civil Rights (OCR) published the Interim Final Rule with request for comments on breach notification of protected health information (PHI), which set forth additional definitions and standards to relating to the Privacy Section. OCR is expected to issue the Final Rule by the end of this year or early next year.

When OCR published the Interim Final Rule last year, the media jumped on the inclusion of instructing the covered entity responsible for a breach of PHI to perform a risk assessment as a deciding factor of whether or not to disclose the breach to the individuals and the Department of Health and Human Services (HHS). Eight members of Congress expressed their concern by writing a letter to Kathleen Sebelius, noting that the American Recovery and Reinvestment Act (ARRA) that sets forth the statutory mandates relating to privacy of PHI does not include nor imply a harm standard and urged HHS to repeal or revise the harm threshold standard.

Section 13402 of the ARRA states that health care entities must notify the individual when there is an “unauthorized acquisition, access, use, or disclosure of protected health information which compromises the security or privacy of that information.” In order to decide whether a breach compromises the individual’s security or privacy, the Interim Final Rule set forth a risk assessment criteria and translated a “compromise” of security or privacy to mean a “significant risk of financial, reputational, or other harm” to the individual. Problematically, the covered entity is tasked with assessing the risk of harm to determine whether it meets the threshold for disclosing the breach to the individual and HHS. The Interim Final Rule states that the covered entity should consider to whom the information was disclosed, the type and amount of information, and whether the information contained materials relating to potentially stigmatizing health conditions.

The letter written on behalf of eight Congressional representatives clarified that Congress specifically excluded a threshold for harm when promulgating Section 13402. Furthermore, requiring mandatory disclosure serves as a powerful incentive to health care entities to enact strict privacy and security protections to decrease the likelihood of a breach even occurring.

The Keystone Mercy Health Plan and AmeriHealth Mercy Health Plan (MHP) incident is only the latest in a long line of PHI breaches. In late October, the Philadelphia Inquirer reported that a computer flash drive belonging to Keystone Mercy Health Plan and AmeriHealth Mercy Health Plan (MPH) was lost at a community health fair. The flash drive contained the medical record information of over 280,000 Pennsylvanian Medicaid recipients.

Donna Burtanger, Vice President of Communications at MHP, stated that company representatives were trying to use the health plan members’ PHI to personalize service at community health fairs. Burtanger offered the example of when a health plan member visits a church sponsored health fair, the insurance company representative can access the member’s medical record to schedule an appropriate screening test such as a mammogram.

As one article pointed out, MHP assumes that the patients under the plan would want company employees to have and access the patient’s full medical record or bring that sensitive health information into a less secure location such as a community health fair. This situation highlighted the vast discrepancy between how an insurance company and its members would view the risk-benefit calculation of permitting non-essential access of their sensitive medical information.

If a health insurance company such as MHP does not know when its members would not want their information shared, accessed, or transported, it likely would also face a disconnect when attempting to determine potential harm arising from a breach of its members’ PHI and whether that level of harm would require disclosure of the breach.

OCR should consider whether placing a level of discretion in the hands of health care entities given the knowledge of this difference will build the public’s trust of using electronic health information.


--Katherine Drabiak-Syed

Friday, October 29, 2010

Nuffield Council Reviews DTC Genetic Testing

The Nuffield Council on Bioethics recently released the results of a two year study: Medical profiling and online medicine: the ethics of 'personalised healthcare' in a consumer age (2010). The report devotes chapters to six "case studies" (these are not formal case studies, but rather topics for investigation), all are relevant to the ethical development and delivery of predictive medicine. The six case studies address: online health information, online personal health records, online purchasing of pharmaceuticals, telemedicine, personal genetic profiling for disease susceptibility, and direct-to-consumer body imaging.

However, the chapter on direct-to-consumer (DTC) genetic testing, 9. Personal genetic profiling for disease susceptibility, will be of particular interest to readers in the States. Three of the big names in DTC genomics are U.S. companies (Navigenics, 23andMe, and Pathway Genomics) and, given the price tag for services, much of the consumers are in the States as well. In general, the Council cautions that DTC genetic testing lacks a sufficient evidence base for reliable clinical use and that consumers should think carefully about the risks. Nevertheless, the workgroup does not oppose the market for DTC genetic testing, but rather advices companies to provide greater transparency regarding the evidence and the potential harms. On the regulatory front, the report proposes prohibiting the market for tests with no proven clinical utility. See 9.45:

We recommend that responsible authorities pay more attention to whether genetic test providers are making clinical claims for their products, even if implied rather than explicit (such as in their ‘customers’ testimonials’). If so, they should ask for evidence to be supplied. We direct this recommendation to authorities responsible for pre-market review and advertising standards, including the Medicines and Healthcare products Regulatory Agency and the Advertising Standards Authority in the UK.

The council also calls for government (UK) websites to publish the risks and limitations of DTC genetics, for restricting pediatric DTC genetic services, and for programs to educate healthcare providers who may need to discuss DTC genetic test results with patients.

In addition to the six "case studies" the report also provides a chapter devoted to ethical values the workgroup identified as well as the process of ethical reasoning it employed. The workgroup the following ethical values to consider:

1. The value of safeguarding private information;
2. The value of individuals being able to pursue their own interests in their own way;
3. The value of efforts by the state to reduce harm;
4. The value of using public resources efficiently and fairly;
5. Sharing risks, protecting the vulnerable: the value of social solidarity.

These values, of course, are often in conflict with each other. Thus, the workgroup employed a practical approach (not to resolve) but to "soften" conflicts, see 3.18:

[T]he approach we follow in this report is not so much to attempt to solve the dilemmas but to propose forms of oversight and voluntary conduct so that society can manage its way around them and reduce the conflict while gaining general assent. This approach means trying to accommodate as many as possible of the different values we have identified without giving one absolute priority over another.

I think this is a pragmatic approach, but (perhaps) too obvious to bear replicating. It might have been more interesting to learn how the workgroup identified the five ethical values it employed.

In addition to its well-considered case studies, and explained ethics practice, the report serves as a valuable review (with an emphasis on the issues in the UK) of the literature on the ethics of personalized and genomic medicine. It can be downloaded at no cost from the Council's website: http://www.nuffieldbioethics.org/

Other Predictive Health Ethics News


Tara Parker-Pope. Taking genetic history to the grave. Well (NYT Blog). October 28, 2010.
Rita Rubin. Most doctors are behind the learning curve on genetic tests. USA Today. October 25, 2010.
Laurie Udesky. The ethics of direct-to-consumer genetic testing. The Lancet. October 23, 2010.
Jessica Reaves. Stem Cell Research Skirts Hurdles, but Raises Ethics Issues, Too. The New York Times. October 22, 2010.
Philippa Brice. Loss of UK genetics public bodies confirmed. PHG Foundation News. October 15, 2010.
Experts warn about genetic tests. Reuters. October 12, 2010.
Matt Ridley. The Failed Promise of Genomics. The Wall Street Journal. October 9, 2010.
Amy Harmon. Stem Cells in Court, Scientists Fear for Careers. The New York Times. October 6, 2010.
Josephine Johnston. America’s Stem Cell Mess. The Scientist. October 1, 2010.
Dan Vorhaus. HHS Pulls the Plug on Genetics Advisory Committee. Genomics Law Report. September 23, 2010.

-- J.O.