News from Germany: Organ Transplantation and “Research Donations” – Round 2?

On July 21, 2012, the Bundespraesident, the German Chancellor Dr. Angela Merkel and the German Health Minister D. Bahr finally signed the “The Act to Amend the German Transplantation Act” (“Transplantationsgesetz”, “TPG”.  It is published in the Federal Law Gazette Number 1, BGBl. I 35/2012, p. 1601 and became effective on August 1, 2012.  The act has been described here at PredictER News, July 20, 2012.

From day one, the act has had its critics, in large part, because of the organ transplantation scandal uncovered at the University of Goettingen (Germany) in June 2012.  An organ transplantation specialist is believed to have manipulated medical records in exchange for money so that several patients were able to receive organs through Eurotransplant earlier than it otherwise would have happened. Eurotransplant is responsible for the allocation of donor organs in Austria, Belgium, Croatia, Germany, Luxembourg, the Netherlands and Slovenia (information from Eurotransplant). Currently, because of the suspicion of homicide in 23 cases, the German Law Enforcement Agency (“Staatsanwaltschaft Goettingen”) is leading investigations. The Staatsanwaltschaft Goettingen is investigating if the manipulation of the medical records caused the death of other patients. The agency is investigating whether or not patients were not able to obtain organs in time, because the donations had been given to other patients for whom the medical records and (with that) the listings in Eurotransplant had been manipulated.

Because of this severe incident, the German Organ Foundation, among others, is already advocating for amendments to the TPG to better ensure the safety and quality of organ donations. A better control system other than as regulated in the Act to Amend the German Transplantation Act should be established.  For now the German Health Minister does not see the necessity for changes; however, he does not exclude changes in the future.

Consequences for Research with Human Cells and Tissue?

The incident might also influence the use of human cells and tissue in research. At the moment, the confidence in the fairness of organ and tissue donations has decreased. It remains to be seen, to what extent the organ transplantation scandal will influence research donations and if the German Organ Transplantation Act will be amended again. In both cases, the trust of the citizenry has to be regained.

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

News from Germany: Organ Transplantation and “Research Donations”

On May 25, 2012, the Parliament of the Federal Republic of Germany (“Deutscher Bundestag”) passed “The Act to amend the German Transplantation Act” (“Transplantationsgesetz”, “TPG”, BT-Drs. 17/9773) and “The Law to Regulate the Opt-In Solution for Organ Transplantation” (BT-Drs. 17/9774, BT-Drs. 17/9030). Only a couple of weeks later, on June 15, 2012, the Bundesrat (one of the German constitutional bodies) has acknowledged both acts (Art. 77, 78 of the German Constitution). According to Art. 50 of the German Constitution, the federal states participate in the legislation and administration at a federal level and in matters concerning the EU through the Bundesrat.

Last but not least, the acts have to be signed and certified by the current Federal President Joachim Gauck (“Bundespraesident”) and promulgated in the Federal Law Gazette to become effective (Art. 82 of the German Constitution). On July 12, 2012, the Bundespraesident, the German Chancellor Dr. Angela Merkel and the German Health Minister D. Bahr signed the Law to Regulate the Opt-In Solution for Organ Transplantation. It is published in the Federal Law Gazette Number 1, BGBI. I 33/2012, p 1504 and becomes effective on November 1, 2012. The signature for the Act to amend the German Transplantation Act is still pending, but is expected soon. The goal of both laws is to increase the number of organ donations.

The Act to Amend the German Transplantation Act

The Act to Amend the German Transplantation Act (BR-Drs. 292/12) results from the implementation in national German law of the European Directive 2010/45/EU of the European Parliament and of the Council of 7 July 2010 on standards of quality and safety of human organs intended for transplantation. Directive 2010/45/EC only applies to organs used in research where they are intended for transplantation into the human body, Art. 2 Subsec. 2 Directive 2010/45/EU.

The Act to Amend the German Transplantation Act not only amended the TPG, but also the Social Act related to the statutory health insurance (Social Security Code 5), statutory accident insurance (Social Security Code 7) and the Act of Continued Payment in Case of Sickness (“Entgeltfortzahlungsgesetz”, “EFZG”). The new regulations shall ensure the quality and safety of human organs and improve the transplantation processes in hospitals. Each hospital with an intensive care united must appoint a transplantation officer (§§ 9a, 9b TPG as amended).

The rights of living donors are also enhanced. Each living donor is now entitled to claim reimbursement for medical treatment expenses, travel expenses, expenses for rehabilitation and sick payments related to the transplantation from the organ recipient’s statutory or private health insurance (§ 3a of the Act of Continued Payment in Case of Sickness; Paragraphs 27 Subsec. 1a, 44a Social Security Code 5). The private health insurance companies entered into a voluntary agreement on February 9, 2012 to cover the expenses of living organ donors, including medical treatment, travel, lost earnings, and rehabilitation. In addition, organ transplantation is now considered as unemployment through no fault of the donor so that the living donor now can claim continued payment of remuneration for six weeks. Medical treatment of donors will be provided by highly specialized physicians.

The most important change addresses the statutory accident insurance for any health damages caused by the organ donation procedure, which exceed the regular impairment of health (§ 12a Social Security Act 7). In this case, any claim related to the health damage, e.g. kidney failure after kidney donation, will be covered by the accident insurance instead of the health insurance. The Act to Amend the German Transplantation Act also covers cases of health damages occurred since 1997 (§ 213 Subsect. 4 Social Security Act 7). With these new regulations, statutory health insurance does not have to cover the costs and will be financially relieved.

The Law to Regulate the Opt-In Solution for Organ Transplantation 

To increase the willingness to donate organs among the citizens, the Law to Regulate the Opt-In Solution for Organ Transplantation regulates the opt-in solution for living and post mortem donations. The extended approval has been changed to informed consent (opt-in). The new informed consent requirement is regulated in § 1 Subsec. 1 TPG (as amended) as follows:

"(1) Goal of this Act is to support the willingness of organ donation in Germany. Thus, each citizen has to be put in a position to question the own willingness to donate organs on a regular basis and to document the decision. To ensure a voluntary and informed consent a broad general education about the possibilities to donate organs and tissues is included." (my translation)

The new law, while protecting donors, asks each German citizen to make a decision on organ transplantation. Each German citizen older than 16 years will receive a letter from the health insurer informing them about the possibility to donate organs (§ 1 Subsec. 1a TPG as amended). Everyone will be informed and asked on a regular basis. To ensure that a voluntary consent is given, the German Federal Centre for Health Education (“BZgA”) as well as the statutory and private health insurances are responsible to educate the citizens as well.

Consequences for Research with Human Cells and Tissue?

The most recent changes to the TPG do not have direct consequences to biobanks and research with human cells and tissue. However, the TPG justifies the necessity to obtain an informed consent from study subjects before using human cells and tissues in research. Specifically, based on the regulations in the TPG, informed consent is required prior to post mortem donations of cells and tissue for research. The use of human cells and tissue in research is not directly regulated under German laws. Therefore, other laws such as the TPG are applied to the research use. Thus, the same standard that applies to organ donations should also apply to research donations. As such informed consent is now, more than ever, mandatory.

These developments lead to important questions. For example: How, following the organ donation model, can increased education about the use of human tissue in research improve patients willingness to be research donors? Would it be ethical to require people to make a decision to donate their cells and tissue for research? Would such a regulation have an influence on the voluntariness of informed consent?

In addition, the Act to Amend the German Transplantation Act only regulates that donors of organs and tissue will be reimbursed for their expenses (see above). The Act does not state explicitly if this regulation is also applicable for donors of organs and tissues used in research. At the same time, nothing in the act says that the new regulation is not applicable for the research donations. Can the act be used to reimburse “research donors”? Would it be legal and ethical to reimburse research donors in the same way as organ donors? Should a research donation be seen in the same way as the commonly known organ transplantation?

I intend to address these and other questions in a separate publication that I will describe in future posts.

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

Celltex Under Fire by the FDA

A week ago the FDA released its 483 inspection report relating to Celltex Therapeutics Corporation’s practices banking and facilitating the administration of adult stem cells for therapeutic purposes.  News sources (here and here) and the Center for Genetics and Society published portions of its startling findings.  Celltex processes, multiplies, distributes, and facilitates the injections of mesenchymal cells derived from adipose tissue using technology licensed from RNL Bio based out of Seoul, South Korea.  Prominent physician Carl Elliot, MD, PhD and bioethicist Leigh Turner, PhD have both expressed public concern about Celltex’s seemingly flagrant circumvention of FDA regulatory standards, licensing partnership with a controversial corporation, and conflict of interest in the oversight of its operations.

Since its opening in December 2011, Celltex is the largest stem cell bank in the US and facilitates the process and supplies the product for individuals seeking to receive stem cell injections, charging a hefty fee ranging from an estimated $20,000-$30,000 for its services.  It has garnered significant publicity arising in part from Texas Governor Rick Perry’s support, his personal use of stem cell injections for a back injury, and Perry’s push for state legislation to create a state adult stem cell banking initiative and revise Texas Medical Board regulations relating to physicians’ ability to administer non-FDA approved stem cell “treatments” to their patients.

Back in February, Turner compiled a letter of listed concerns relating to Celltex’s practices, requesting that the FDA investigate the company’s practices.  Turner and other media sources have pointed out the following, along with other issues:

Celltex has not offered substantial data or clinical trials to show the stem cells it offers are safe and efficacious.   In January 2012 the FDA issued a Consumer Health Information guide cautioning consumers to make sure that any stem cell treatment they consider has been approved by the FDA or is subject to a current protocol submitted to the FDA to ensure that the stem cells are safe, effective, and have undergone adequate and well controlled clinical trials.  Furthermore, the FDA must oversee the manufacturing process to assure the products’ safety, purity, and potency.

If individuals are receiving experimental injections, Celltex and the physician should thoroughly explain that the procedure is experimental medical research rather proven clinical medicine and the risks associated with the procedure.  Both the FDA and physician commentators have noted that patients seeking to have cells injected face safety risks arising from the procedure, even if they are the patient’s own stem cells and the corporation follows good manufacturing practices.  Jamshid Lofti, MD, a neurologist who has administered injections to more than 20 patients has admitted the need for controlled trials, but has problematically downplayed such risks, asserting that “the worst that can happen is it won’t work.”  Not according to the FDA and numerous other physicians, who list potential risks to include tumors, cancer, and even death.  Such risks are at the forefront of investigation (see here and here) into partner company RNL Bio’s practices in South Korea, where former patients and their families have come forth with allegations of cancer and death linked to receipt of RNL Bio’s stem cells. 

Celltex contends that it merely processes and expands individuals own stem cells, only minimally manipulates the cells, and is currently coordinating prospective clinical studies.  According to Nature, Celltex coordinates with physicians and pays physicians $500 per injection, and each patient receives at least three injections.  Celltex argues that the process of culturing and preparing the stem cells does not constitute the manufacture of a biological drug, so the process stands outside the scope of FDA regulations normally required for biological drugs.  A Colorado court is currently examining this issue arising from the practices of another company Regenerative Sciences, who proffered a similar argument to avoid applicability of FDA requirements. 

However, Rita Chappelle, a spokesperson for the FDA’s Center for Biological Evaluation and Research asserts that any “expanded” cells cannot be considered minimally manipulated.  Importantly, the FDA’s 483 inspection form classifies Celltex as a biological drug manufacturer in the business of manufacturing mesenchymal  stem cells rather than minimally manipulating stem cells.  Independently of how Celltex classifies its processes, the 483 report made news headlines based on the number of alarming deficiencies in the processing and manufacturing procedures.  It found Celltex failed to validate processes to prevent contamination; to distinguish between components being quarantined or approved; to routinely calibrate and check the equipment; to review quality processing systems; and could not guarantee the sterility, uniformity or integrity of the cells.  Celltex’s press release in response is here.

Had there been any uncertainty about the scope of FDA regulation, the Consumer Health Information guide back in January clarified that the manufacture of stem cells must undergo FDA review.  Yet Celltex continued its operations charging clients tens of thousands of dollars for unproven and unregulated “treatments,” evaded FDA’s clarification, and exposed consumers to additional risks based on its manufacturing deficiencies detailed in the 483 inspection.  More problematically, associated figures such as Gov. Perry and physicians who administer the injections provide the imprimatur of  Celltex’s practices- creatively flouting regulatory requirements, downplaying risks of the procedure, and reaping hefty profits.  Even in the name of therapeutic progress and statewide economic growth, it is time for the FDA to set an example that such disregard for its jurisdiction and review process will not be tolerated. 

--Katherine Drabiak-Syed

Waiting for November 2012 and the Final Verdict on Brüstle v. Greenpeace e.V.

The German Federal Court of Justice (“BGH”) finally announced that it will decide in the case Brüstle v. Greenpeace e.V. on November 27, 2012.

The case was described and discussed here at PredictER News, December 13, 2012 and June 11, 2012. The court will adjudicate more than two years after it requested preliminary ruling from the European Court of Justice (ECJ) on December 17, 2009 (Case Xa ZR 58/07, now changed to X ZR 58/07), and a year after the ECJ’s decision in Case C-34/10 regarding the interpretation of Art. 6 of the Directive 98/44/EC on October 18, 2011.

The BGH’s decision will not only influence the question of whether or not patents can be gained on inventions which are based on embryonic stem cells, but it will also impact embryonic stem cell research in general. In addition to the German Patent Protection Act, the German Embryonic Protection Act (“ESchG”) is also based on Directive 98/44/EC.

The ESchG prohibits research with embryos, see Paragraph 2 ESchG, but not research with embryonic stem cells. However, Paragraph 2 ESchG has to be interpreted in the terms of the ECJ decision now. As a result, and with ECJ's broad interpretation of the Directive and definition of embryos research with human embryonic stem cells might be prohibited in Germany. In other words, embryonic stem cells would have to be treated as embryos and, as such, research would be prohibited. This prohibition would include even basic research on embryonic stem cells.

Therefore, the German jurisdiction as well as the legislature should examine how the ESchG should be interpreted in future. A change or amendment to the ESchG's definition of embryos should also be deliberated, because under German law, the use of the term "embryo" and its impact on stem cell research needs clarification. Because the ECJ has not directly prohibited embryonic stem cell research, but has persisted in broadly defining "embryo," other than the ECJ the BGH has to take the consequences of its verdict for embryonic stem cell research into consideration.

It still remains to be seen what will happen on November 27, 2012 and what consequences the decision will have on embryonic stem cell research.

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

What happened after the European Courts of Justice decision Brüstle v. Greenpeace e.V.?

More than six months after the European Court of Justice (ECJ) decided Brüstle v. Greenpeace e.V. (Case C-34/10) on October 18, 2011 (which was described and discussed here at PredictER News, December 13, 2012), the German Federal Court of Justice (BGH) has still not made its decision. What happened after the October decision?

Only a couple days after the decision had been made, several representatives of the European Parliament filed a request to the EU Commission to stop the funding of embryonic stem cell research in the EU program, Horizon 2020 (EPP Group in the European Parliament). In their point of view, the ECJ decision indicated that embryonic stem cell research shall cease.

Horizon 2020 is the main EU financial instrument to support research and innovation in the Member States. The research funding budget will cover an amount of about 80 Billion Euro to be used from 2014 to 2020. Horizon 2020 was drafted on the basis of Decision No 1982/2006/EC of the European Parliament and of the Council of 18 December 2006 concerning the Seventh Framework Program of the European (FP7) Community for research, technological development and demonstration activities (2007-2013). Art. 6 Subsec. 2 of the Decision No 1982/2006/EC regulates that research on human stem cells, both adult and embryonic, may be financed, depending both on the contents of the scientific proposal and the legal framework of the Member State(s) involved. However, Decision No 1982/2006/EC was made before the European Court of Justice held in Brüstle v. Greenpeace e.V. that human embryonic stem cell lines have to be seen as embryos.

On May 31, 2012 the 3169th Competitiveness Council meeting was held. Inter alia, the Proposal for a Regulation establishing Horizon 2020, as well as the rules for participation and dissemination, were discussed in the form of a Progress Report. It has been announced that the EU Science Minister finally reached an agreement on the overall structure of the Horizon 2020 research funding program. The proposal of the Committee on Industry, Research and Energy to amend the Horizon 2020 proposal (COM(2011) 811) from November 30, 2011 does not suggest any changes to the Horizon 2020 proposal of the European Commission related to stem cell research. Even though, requests have been filed to stop or lower the funding of embryonic stem cell research the proposal for Horizon 2020 did not change the wording of section 2.1, that “Supporting a large set of embryonic, high risk visionary science and technology collaborative research projects is necessary for the successful exploration of new foundations for radically new future technologies” (COM(2011) 811, Sec. 2.1 of the Council Decision).

The Competitiveness Council agreed that stem cell research will be treated under Horizon 2020 the same as under the 7th Framework Program. The following “Triple-Lock-System” which was established under FP7 will be continued for the funding of stem cell research:

1. National Legislation must be respected and EU projects must follow the laws of the Member States in which the research is conducted; and
2. all projects have to be scientifically peer reviewed and must undergo rigorous ethical review; and
3. EU funding cannot be used for derivation of new stem cell lines or for research that destroys embryos (3169th Competitiveness Council meeting).

The German Federal Court of Justice decision is still outstanding. The final decision on Horizon 2020 (“FP8”) has not been made yet either. It still remains to be seen how the German Federal Court of Justice will decide and which influence the decision will have not only on the German legislation but also on Horizon 2020.

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

Legislatures Race to Define Rights and Obligations Relating to Genetic Information: Avoiding Another Bearder

California is the latest state to take steps toward defining permissible uses and restrictions relating to obtaining, retaining, and sharing individuals’ genetic information.  Senator Alex Padilla recently introduced Senate Bill 1267, the Genetic Information Privacy Act, designed to protect individuals against surreptitious testing of their genetic material without consent.  SB 1267 is a comprehensive piece of legislation which would require a specific authorization to obtain, analyze, or disclose genetic information unless otherwise exempted or allowed by law (exemptions include activities such as newborn screening, duties of the medical examiner, using some types of data for research, and law enforcement uses).  The legislation also contains a civil penalty structure for violations and provides a private right of action for aggrieved individuals who suffer economic, bodily, or emotional harm proximately caused by such violations. 

California’s legislation classifies genetic information within a privacy framework and seeks to increase individual control by requiring the individual to understand the purposes of how the information will be used and stored, as well as which entities have access to the information.  Other states such as Alabama, Massachusetts, South Dakota, and Vermont have introduced similar legislation that govern the collection, retention, and sharing of DNA, genetic information, and or genetic test results.  These states differ in their comprehensiveness and scope- from South Dakota’s paragraph long House Bill 1260 to Alabama’s extensive eleven page House 78.

Unlike California, these states seek to classify DNA, genetic information, and or genetic test results within a property law framework rather than under the umbrella of privacy, which carries distinct legal requirements for transfer, use, and retention.   As legislatures race to define individual rights within existing  legal concepts, they should be well aware of property law’s limitations at upholding individual autonomy while appropriately and efficiently defining permissible research uses depending on how the legislature crafts the language of the statute. 

As we witnessed in the progression of the Bearder v. Minnesota litigation (related to collecting, retaining, and disseminating newborn blood spots) even if a law is seemingly clear, individuals, clinicians, and investigators still may face confusion over relevant terminology and obligations relating to the meaning of key terms and the scope of consent exemptions.  (Blogs and article on that topic here.) Specifically, will these statutes govern the collection, use, and dissemination of genetic information after the analysis of a genetic test using a blood sample or will the language broadly address collecting blood samples, DNA, and genetic test information?  Public health officials, investigators, and individuals have vehemently disagreed over the meaning and scope of these terms and when consent is required.  Individuals have claimed immense injury to privacy and dignity when public health officials and investigators collect, retain, and disseminate their blood samples without consent, while public health officials and investigators decried setbacks to research efforts after they were legally ordered to destroy their improperly obtained blood samples. 

Last November, the Minnesota Supreme Court clarified its state Genetic Privacy Act, holding that an individual’s blood sample contains biological information and biological information falls within the definition of genetic information.   That is, any statutory references to genetic information also applies to blood samples.  It appears that the majority adopted the Plaintiffs' argument  that a blood sample contains DNA and the structure of DNA is genetic information, which means statutory requirements governing the collection, use, storage, and dissemination of genetic information necessarily include blood samples.   

Although this seminal holding is jurisdictionally limited, defining the meaning and scope of biological specimen, blood sample, DNA, and genetic information requires painstaking semantic precision.  Furthermore, the concurrence/dissent in Bearder demonstrates even keen legal minds apply varying logic to interpret terminology and arrive at starkly divergent conclusions.  Defining these terms becomes even more pressing should this or similar state legislation pass because it carries the compliance incentive of a penalty structure for violation.  Legislators should take note of litigation in this area and aim to meticulously and unambiguously define relevant terminology so individuals, public health officials, and investigators can understand their interrelated rights, obligations, and statutory exemptions.  

--Katherine Drabiak-Syed

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