Papers by Markus Frischhut
Public health laws are among the most ancient health laws. Long before states had complex healthc... more Public health laws are among the most ancient health laws. Long before states had complex healthcare financing systems or regulated pharmaceuticals and medical technologies, they enacted laws designed to stem fearsome epidemics and protect their populations from the more common diseases that plagued the pre-modern era.1 Over the past 150 years, as medical knowledge has increased and healthcare systems have grown in terms of cost and complexity, public health law has often been overshadowed by other areas of health law. That may now be changing. In the face of emerging infectious diseases, such as SARS, Ebola, and COVID-19, and a growing appreciation of the critical role that social, environmental, and economic forces play in shaping public health, policymakers and scholars have begun to pay increasing attention to the theoretical foundations of, ethical justifications for, and scope of public health laws. In the three paired chapters that follow, we focus on three critical areas of public health law: communicable disease control, the control of noncommunicable diseases (NCDs), and efforts to address the social determinants of health. In each set of paired chapters, we follow a common structure and consider the US perspective on the one side and the European perspective on the other. The analyses that emerge from these chapters, which were written before COVID-19 overtook much of the globe, reveal that legal systems on either side of the Atlantic face broadly similar questions. These include: What is the appropriate scope of public health law? How should responsibility be divided between centralized and more localized authorities? What circumstances justify the limitation of individual liberty to protect public health? How should governments regulate in the face of scientific uncertainty? And, what protections should be in place to prevent public health laws from targeting vulnerable individuals and populations?
Digitalisation and other forms of new technologies present us with new challenges. Laws often lag... more Digitalisation and other forms of new technologies present us with new challenges. Laws often lag behind this need for regulation. In recent years, there have been numerous references to "ethics" in EU law. At the same time, numerous documents around the world on artificial intelligence and robotics refer to principles and values. This article explores the role of EU values (in general and specific to certain areas, such as the health sector) and the role of ethical and legal principles in addressing these challenges. An increased role of values and ethics in this area is important to ensure trust.
This chapter moves from the general task of defining integrity, to the more specific issue of ide... more This chapter moves from the general task of defining integrity, to the more specific issue of identifying the status quo of ethics and values in the particular context of the European Union (EU). Here, diversity seems to hinder a consistent philosophical understanding, that is, a constitutional ideal, of ethics and morality in EU law and its politics. As it plays a key role in this regard, the authors will analyse the opinions of the European Group on Ethics in Science and New Technologies (EGE). The EGE is an “independent”, “pluralist”, and “multidisciplinary” advisory body comprised of experts from various fields. It is mandated by the European Commission with the objective of advising the Commission on ethical questions, in the particular field of science and new technologies, which often evoke fundamental questions towards a moral understanding of right and wrong and above all an ethical reflection on its wider societal implication. Given the EGE’s central role for ethics in the EU, its sometimes-questioned independence and its discretion on deliberating about ethically contested issues, the EGE’s potential political tendency is at times called into question due to the alleged religious or other partial affiliations underpinning its philosophical orientations on ethically contentious topics. This chapter addresses the issue of possible tendencies towards certain philosophical normative theories – deontological, consequentialist, or virtue-based philosophies, reflected in the opinions of the EGE on various ethically contested issues.
Digitisation and other forms of new technologies present us with new challenges. Laws often lag b... more Digitisation and other forms of new technologies present us with new challenges. Laws often lag behind this need for regulation. There have been numerous references to "ethics" in EU law in recent years. At the same time, numerous documents worldwide on artificial intelligence and robotics refer to principles and values. This article examines the role of EU values (general and specific to specific areas, such as the health sector) and the role of ethical and legal principles in meeting these challenges. A strengthened role of values and ethics in this area is important to ensure trust.
Medicine, 2020
Medical ethics is a field of expertise that has developed alongside increasingly powerful technol... more Medical ethics is a field of expertise that has developed alongside increasingly powerful technologies that have changed medical practice significantly over the past decades. From artificial ventilation and the possibility of resuscitation after cardiac arrest in the 1960s to big data-driven genomic medicine of today, modern medicine is loaded with ethical dilemmas and complex decisions. Four principles, namely respect for autonomy, non-maleficence, beneficence and justice, were identified in the 1970s as guiding concepts of an ethics of biomedicine, the then emerging clinical practice that is informed by biological and physiological evidence from basic research. However, as cultural and historical context affects understanding of these principles, their implementation in clinical practice and healthcare is not trivial. Here, we highlight additional principles and values that back up these four core principles in the European context, particularly solidarity, human dignity, pluralism, tolerance, non-discrimination and gender equality. We further summarize how European Union law reflects such principles and values, and refer to existing instruments to support their implementation. Focusing on solidarity, we highlight its understanding in the European context as well as some challenges for its realization.
Europarecht, 2020
In seiner Rsp. hat der EuGH aus der (passiven) Dienstleistungsfreiheit Rechte von PatientInnen in... more In seiner Rsp. hat der EuGH aus der (passiven) Dienstleistungsfreiheit Rechte von PatientInnen in der grenzüberschreitenden Gesundheitsversorgung entwickelt, die 2011 in einer Richtlinie (2011/24/EU) kodifiziert worden sind. Daneben finden sich ähnliche Rechte in der Verordnung über die soziale Sicherheit (883/2004/EG). Diese drei Rechtsgrundlagen kommen auch im EWR zur Anwendung. Neben dieser legislativen Homogenität untersucht dieser Beitrag insb. die judikative Homogenität i.S.d Übernahme dieser EuGH Rsp. durch den EFTA-GH, aber auch in die umgekehrte Richtung. Eine besondere Rolle spielen dabei sowohl für anerkannte als auch für experimentelle Behandlungen der Hinweis auf den internationalen „State-of-the-art“, sowie die Unterscheidung in Behandlungstypen bzw. Behandlungsmethoden.
Feeney, O., Werner-Felmayer, G., Siipi, H., Frischhut, M., Zullo, S., Barteczko, U., . . . Rakić, V. (2020). European Electronic Personal Health Records initiatives and vulnerable migrants: A need for greater ethical, legal and social safeguards. Developing World Bioethics, 20(1), 27–37. Developing World Bioethics, 2020
The effective collection and management of personal data of rapidly migrating populations is impo... more The effective collection and management of personal data of rapidly migrating populations is important for ensuring adequate healthcare and monitoring of a displaced peoples’ health status. With developments in ICT data sharing capabilities, electronic personal health records (ePHRs) are increasingly replacing less transportable paper records. ePHRs offer further advantages of improving accuracy and completeness of information and seem tailored for rapidly displaced and mobile populations. Various emerging initiatives in Europe are seeking to develop migrant‐centric ePHR responses. This paper highlights their importance and benefits, but also identifies a number of significant ethical, legal and social issues (ELSI) and challenges to their design and implementation, regarding (1) the kind of information that should be stored, (2) who should have access to information, and (3) potential misuse of information. These challenges need to be urgently addressed to make possible the beneficial use of ePHRs for vulnerable migrants in Europe.
Grad, J., & Frischhut, M. (2019). Legal and Ethical Rules in EU Decision-Making: “Soft Law” for Targets and Actors of Lobbying. In D. Dialer & M. Richter (Eds.), Lobbying in the European Union: Strategies, Dynamics and Trends (pp. 305–327). Cham: Springer. , Jan 2019
While lobbying can play an important role for democracy, it needs to find its limitations both in... more While lobbying can play an important role for democracy, it needs to find its limitations both in legal as well as ethical provisions. At EU level, we find such provisions mainly in Codes of conduct, a form of soft law. Besides rules on transparency, conflict of interests and the revolving doors phenomenon, these documents refer to ethical principles mainly in an implicit way, by using terms as “integrity”, “diligence”, “honesty”, “accountability” etc. Those provisions mainly apply for the targets of lobbying, while we find similar, however less, provisions concerning actors of lobbying. Recent changes adopted by Parliament and Council can be seen as important steps towards more ethical lobbying, an important step towards regaining European citizen’s trust.
This contribution depicts quality of care and patient safety in EU cross-border healthcare. While... more This contribution depicts quality of care and patient safety in EU cross-border healthcare. While EU primary law requires a high level of health protection, it is basically soft law which has shaped the content of quality of care and patient safety. Similarly as in patient mobility in general, different CJEU cases have paved the way, with more details added in Directive 2011/24/EU etc. Finally, this contribution also highlights the related fields of quality and safety in the context of the three Directives on Blood, Tissues and Cells, and Organs.
The chapter presents the historic development of EU communicable disease control law and policy s... more The chapter presents the historic development of EU communicable disease control law and policy since the 1990s, using the lens of European integration theory to explain why it is a case of some relatively common dynamics in European integration. It is a story of a developing network, institutional entrepreneurs, agenda-setting and alternative specification in policy debates. We highlight key milestones and challenges. These are further explained in an elaboration of the status quo of EU communicable disease control, which also deals with some selected key issues of this cross-cutting challenge from both a policy and law perspective. Finally, we address possible future directions of travel.
The phenomenon of cross-border reproductive care raises a number of sensitive and cutting edge pr... more The phenomenon of cross-border reproductive care raises a number of sensitive and cutting edge problems, both from a legal, as well as from an ethical perspective. The objective of this contribution is to tackle some of them by means of a case study which entails five examples of assisted reproductive technology (ART), that is to say in the field of in vitro fertilisation (IVF) and/or surrogacy, all examples – except the last one – based on real court cases. This contribution covers some of the issues that can arise, mainly based on selected cases, as decided by different national or European courts (CJEU and ECtHR).
The case-law of the Court of Justice (ECJ) on patient mobility was recently challenged by a rulin... more The case-law of the Court of Justice (ECJ) on patient mobility was recently challenged by a ruling that a patient could go to Germany for treatment when facilities in Romanian hospitals were inadequate. Given the reported impact of austerity measures in the field of health care this raises the question; what is the impact of the ECJ's ruling on how Member States can manage expenditure and limit outflows of patients and how should such measures be legally evaluated? The objective of this paper is to analyse potential impact on health systems in the context of increasing pressure on public financing for health. While the ECJ mainly referred to the requirement of treatment in due time, we also analyse possible austerity reductions of the basket of care against the background of EU law (i.e., ECJ case-law, patient mobility directive, Charter of Fundamental rights and social security regulation).
In various (binding and non-binding) legal documents, the European Union (EU) refers to “ethics” ... more In various (binding and non-binding) legal documents, the European Union (EU) refers to “ethics” and “morality”, without providing a definition or even referring to a common understanding. However, if a certain activity is qualified as “unethical”, there can be important consequences, such as stringent ethics reviews in case of the use of human stem cells under the “Horizon 2020” program, or, under the same program, the exclusion from funding, or, under the “EU Patient Mobility Directive”, no right to cross-border healthcare, to name but a few. This article focuses both on EU Primary and Secondary law, with a special emphasis on the latter. I will argue that in a lot of cases, ethics is (only) used in order to avoid interference of the EU in Member States’ competences, especially in sensitive fields, like abortion. However, there are also examples where the relevant content is determined, either by Ethics Committees and/or Code of Conducts, either at EU or at national level. Nevertheless, other situations remain undetermined. I will further argue that the determination of ethics should be carried out by referring to the EU’s values and fundamental rights, especially the “corner stone” of human dignity.
Since 1998, the European Court of Justice (EUCJ) has established a set of principles con-cerning ... more Since 1998, the European Court of Justice (EUCJ) has established a set of principles con-cerning patient mobility across Member States. At present, these principles are challengedagainst a new background, i.e., an enlarged EU and austerity-driven measures in the fieldof healthcare. This is even more relevant in view of the significant differences betweencountries and between services on healthcare access. In the Petru case, a Romanian womansought healthcare in Germany due to an alleged lack of basic infrastructure in her localRomanian hospital. A crucial question arises in this context of whether the patient's inter-ests (i.e., right to cross-border healthcare) or the Member State's interests (i.e., financialstability of the healthcare system) prevail. We analyse this case and its implications forfuture patient mobility. From the point of view of patients, the EUCJ's decision impliesthat also a lack of medication and basic medical supplies can be claimed as “undue delay”,however for Member States it is sufficient to provide quality treatments in at least onehospital. Although the Court has provided a solution for the Petru case, we argue thatmajor challenges remain, such as the definition of the international state-of-the-art or otherlimitations to reductions of the health basket.
Das sowohl primär- als auch sekundärrechtlich (mehrfach) verankerte Recht auf Dokumentenzugang er... more Das sowohl primär- als auch sekundärrechtlich (mehrfach) verankerte Recht auf Dokumentenzugang erfüllt für Unionsbürger sowie sonstige (natürliche und juristische) Personen eine wichtige (nicht nur demokratiepolitische) Funktion. Dieser Beitrag untersucht allgemeine Weiterentwick-lungen dieses Rechts in der Rechtsprechung des EuGH und berücksichtigt insbesondere den Umweltbereich (Århus). In all diesen Bereichen sind gegenläufige Interessen, wie z.B. der Schutz von Untersuchungstätigkeiten (in Vertragsverletzungsverfahren und im Wettbewerbsrecht), mit dem Interesse an Transparenz in Einklang zu bringen. Sektorenübergreifend bedient sich der EuGH dabei einer „Vermutungs-Rechtsprechung“, die zu einer nicht zu unterschätzenden Beweislastumkehr zu Lasten der Antragsteller (Unionsbürger) führt.
Die Presse, Rechtspanorama, Oct 20, 2014
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Papers by Markus Frischhut
Zwischen den beiden Polen von Art. 168 AEUV einerseits und den Grundfreiheiten andererseits (insb. DLF) hat der EuGH Prinzipien der Patientenmobilität entwickelt, die in RL 2011/24/EU kodifiziert worden sind.
In der EU kommen ähnliche trianguläre Rechtsquellen zur Anwendung, wie im Verhältnis zu Norwegen, Island und Liechtenstein.
Im einzigen Urteil in diesem Kontext, Rindal and Slinning, hat der EFTA-Gerichtshof auf zahlreiche der vom EuGH entwickelten Prinzipien rekurriert (vgl. Prinzip der Homogenität, Art. 6 EWR Abkommen, etc.).
Dabei hat er nicht nur die wesentliche Unterscheidung in ambulante vs. Krankenhausbehandlung angewandt, sondern auch den Hinweis auf den internationalen State-of-the-art.
Es ist interessant zu sehen, dass – insb. seit der Umsetzung von RL 2011/24/EU – neue Fragestellungen nicht aus dem Bereich der EU, sondern aus dem EWR (i.d.F. Norwegen und EFTA Surveillance Authority) kommen.
Vortrag im Rahmen der GCL Brüssel Exkursion | 26. Oktober 2017 | Tirol-Büro Brüssel
Method: Based on the EU’s (EUR-Lex) and different national legal databases, this presentation will analyze if EU Member States (EU-MS) have also referred to those concepts (ethics, morality and related key-terms such as values etc.) when implementing these directives. This research group has covered the following countries: Austria, France, Germany, Ireland, Spain, and the UK.
Results:
• The 27 directives mainly pertain to the field of healthcare, addressing issues of bioethics. Therefore, the majority of references to these concepts can be found in the field of healthcare, mainly referring to “ethics” (less to “morality”).
• This is also true for the NIM, which mostly refer to ethics and especially “ethics committees”; primarily due to the clinical trials directive.
While some references to ethics etc. where unavoidable (i.e. mandatory for the EU-MS), we cannot observe a uniform “ethicalization” (Vöneky et al., 2013) via EU law in these six countries. Nevertheless, the EU’s values (especially human dignity, human rights and justice) need to be referred to when dealing with those NIM.
The Petru case concerned treatment received in Germany due to alleged inadequate treatment in a Romanian hospital. Other than the Advocate General, the Court has not explicitly referred to the question whether the principles it has established for cross-border care (especially concerning undue delay) are also valid in a situation of “structural and prolonged deficiencies” in hospital facilities.
Given the reported impact of austerity measures in the field of health care (e.g. Azzopardi-Muscat et al. 2015; Eurofound 2014; OECD 2014; WHO 2014) this raises the question; what is the impact of the Court’s ruling on how Member States can manage expenditure and limit outflows of patients and how such measures would have to be legally evaluated.
The objective of this paper is to analyse potential policy impact on health systems in the context of increasing pressure on public financing for health and against the background of EU law.
Given the fact that nowadays there are different tracks that patients can use when going abroad, this paper starts with an analysis of the ECJ’s case-law (especially concerning undue delay) interpreting the freedom of services. At the level of EU secondary law, the paper analyses the differences, especially in relation to prior authorisation, undue delay and up-front-payments between the social security regulation (both the old and the current setting) and the patient mobility directive. In the end the paper will also evaluate under which circumstances the CFR (Article 35) could tip the scale in case of denied cross-border healthcare.
Policy and Economic Background of the Directive
The framework of the Directive and the main definitions
Relations with other Union provisions
Method: In this research, the author reviewed both EU Primary (TEU, TFEU), and especially EU Secondary law. In the latter category, approx. 60 relevant documents have been identified, where the term “ethics” (etc.) has been used. A special emphasis has been put on bioethics, although also other sectors have been involved in this study, in order to draw a more holistic picture.
Results: I will argue that in a lot of cases (especially EU Primary law), ethics is (only) used in order to avoid interference of the EU in Member States competences, especially in sensitive fields, like abortion. However, in EU Secondary law there are also positive approaches of increasing clarity. This is done by Ethics Committees and/or Code of conducts, in both cases either at EU or at national level. In some examples, there are even some hints or references to other sources, or to the national level, in order to determine the relevant content. Still, there are also documents without any determination as regard the content.
I will further argue that those gaps mainly have to be filled at EU level with reference to the EU fundamental rights, especially the “key stone” of human dignity, the right to life and the right to integrity (Articles 1-3 of the EU Charter).
This book analyses the evolution of values (ratione temporis) and the questions of who is entitled and who is obliged (ratione personae). Besides the external perspective (ratione limitis; e.g., Brexit), it focuses on the composition of the EU’s common values (ratione materiae). As Art 2 TEU can be viewed as a hub, it is essential to focus on various relations, not only between values, but also between values and other provisions of EU law, as well as other concepts.
Based on this description of the status quo, the book subsequently addresses a possible future direction, arguing for an additional narrative (trust), an additional value (environmental protection), and a more communitarian Union. In closing, apart from the classical commitment of the EU and the Member States to uphold the values of the EU, the book discusses the level of individuals and values as virtues. Various figures and tables complement this overview of the status quo of the Union of values and outline of its future direction.
Grundlagen der EU. Die Struktur, Institutionen
und Rechtsprinzipien der EU werden kompakt und übersichtlich
dargestellt. Ein weiterer inhaltlicher Schwerpunkt
wird auf Aspekte des EU-Rechts gelegt, die auch
für Nichtjuristen interessant sind, wie Bürgerrechte, Entscheidungsprozesse
und die vielfältigen Aktivitäten der
EU im Rahmen der verschiedenen Politikfelder.
Das Buch wendet sich vor allem an Studierende, die
sich grundlegende Kenntnisse des EU-Rechts aneignen
wollen, und an alle an der EU Interessierten.
Weniger einfach sind hingegen die aus mehreren Urteilen des Europäischen Gerichtshofs (EuGH) einzelfallbezogen entwickelten Rechte einerseits, sowie die sich aus der aktuellen Patientenmobilitäts-Richtlinie (vom 9.3.2011) ergebenden Änderungen andererseits. Dieses Werk soll dieses Thema der Patientenmobilität daher umfassend und so einfach wie möglich darstellen.
Es richtet sich einerseits an Patienten sowie an im Gesundheitsbereich tätige Personen, denen es zahlreiche Übersichten und einen – wo möglich – aus Patientensicht geglie-derten Aufbau bietet. Mit zahlreichen Quellenangaben und einer genau aufgearbeiteten Entstehungsgeschichte eignet sich das Buch aber ebenso als Informationsquelle für Lehrende und Studierende in den Bereichen EU-Recht, Gesundheitsmanagement etc."
Das Handbuch behandelt auf Basis eines „case law approach“ die Anwendung des EU-Rechts und seinen indirekten Vollzug in Österreich anhand der Rechtsprechung des EuGH, VfGH, VwGH und, wo es Berührungspunkte gibt, des OGH, des EGMR und sonstiger Gerichte. Dabei werden insbesondere die Wechselwirkungen und Bezüge zwischen EU-Recht und nationalem Verfassungs- und Verwaltungs(verfahrens)recht aufgezeigt.
Schwerpunkte der Darstellung sind:
• Struktur-, Auslegungs- und Anwendungsprinzipien
• Funktionsprinzipien des allgemeinen Diskriminierungsverbots, der Freizügigkeit der Unionsbürger und der Grundfreiheiten
• Unionsgrundrechte, Staatshaftung
• Grundsätze des indirekten Vollzugs und doppelte Bindung
• Umsetzung, Anwendung im Verwaltungsverfahren und Rechtsschutz
Die durch zahlreiche Auszüge aus Leitentscheidungen angereicherte Darstellung erschließt rund 800 wichtige Urteile. Dadurch wird Praktikern sowie Studierenden und Lehrenden in rechtswissenschaftlichen Fächern ein konziser Überblick und schneller Zugang zu dieser wichtigen Thematik ermöglicht."
Im EU Recht ist Ethik vor dem Hintergrund der gemeinsamen Werte (insb. Menschenwürde) und der Grundrechte zu sehen.
So wie die Werte der EU zu gegenseitigem Vertrauen unter den Mitgliedstaaten führen, so sind Werte und Vertrauen auch im Bereich KI etc. im Verhältnis zu den BürgerInnen von Bedeutung (KOM[2019] 168 endg.; EAG, 2018, S. 20; etc.).
Neben den Werten sollen auch Prinzipien (Transparenz, Integrität, etc.) sowie das „Vier-Prinzipien-Modell“ (Beauchamp & Childress, 2013; Floridi et al., 2018) eine Rolle spielen (krit.: Mittelstadt, 2019; zu möglichen Risiken, siehe auch Floridi, 2019).
Der Vorschlag einer Rechtspersönlichkeit von Robotern (neben natürlichen und juristischen Personen) stößt überwiegend auf Ablehnung (Reinisch, 2019, S. 301, etc.).
Betreffend Haftungsfragen wird mehrheitlich einer Gefährdungshaftung (’strict liability’) der Vorzug gegeben (EP 2017, Pkt. 52-54; CEPS, 2019, S. 121; bzw. zu Datenschreibern, siehe: KOM[2018] 283 endg. S. 139).
Ziel der Kommission ist es, „den Ansatz der Union auch weltweit zur Geltung zu bringen und einen Konsens über eine auf den Menschen ausgerichtete KI zu erzielen“ (KOM[2019] 168 endg. S. 9; so auch EAG, 2018, S. 10; AI HLEG, 2019, S. 5).
Um den Herausforderungen im Bereich Künstliche Intelligenz und Robotik erfolgreich begegnen zu können, benötigt es einen interdisziplinären Ansatz (so auch Rahwan et al., 2019, 183; EAG, 2018, S. 22).
However, taking into account the increasing role of ethics in EU law, this presentation strives to contrast some provisions of EU law with what has been called “the most impressive recent contribution to moral debate about immigration”, a book recently published by “the doyen of normative scholars writing on immigration”, i.e. Joseph Carens’ “The ethics of immigration”.
The objective of this presentation is to see if EU law fulfils some selected demands as stated by Carens. In doing so, this contribution, similar as defined by Carens for his book, aims at generating discussion on this topic. Contrasting such a comprehensive book (more than 340 pages) with the EU’s acquis, it has to be emphasized, that only selected statements of Carens can be compared to selected provisions of EU law.
In light of this, we cordially invite you to join us at this multidisciplinary Conference to allow for academic discussion:
Monday and Tuesday, September 26-27, 2016
Conference: Healthcare in Europe – a safe haven? - “Standard of Care” from a multidisciplinary perspective
Management Center Innsbruck, Universitaetsstrasse 15, Innsbruck
This conference will explore the following questions from a multidisciplinary perspective:
• Which standard of care do countries have to provide to their citizens from a (bio) medical, legal and ethical perspective?
• Which standard of care is required by law; of the European Union (EU), the Council of Europe, or by national constitutional law?
• Which role does healthcare rationing or cost-effectiveness play in this regard?
• Above all, is it possible to define this standard of care, and how do human rights influence this standard?
• Do we have to adopt this standard of care due to ageing societies?
• How could expensive and innovative treatments (e.g. for rare diseases or personalised cancer treatments) enhance access to affordable care, and what role does Health Technology Assessment (HTA) play in this context?
• Which standard of care do patients expect?
• What about patients receiving highly innovative medical treatments abroad, facing discrimination or a lack of treatment supply after returning to their home countries – e.g. in reproductive care?
Please save-the-date and submit your abstract (2000 characters, including blanks) for oral presentation or poster no later than May 15, 2016 via the conference webpage: standardofcare2016innsbruck.mci.edu