Center for Bioethics

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Center for Law, Ethics, and Applied Research in Health Information

Center for Law, Ethics, and Applied Research in Health Information (CLEAR) researchers are actively pursuing information on a range of topics, including use of big data by genomics researchers. These accomplished investigators publish regularly in leading medical, academic and other scholarly publications. They also generate dozens of reports, presentations and book chapters.

Big Data Use by Genomics and Health Informatics Researchers

The project “Big Data Use by Genomics and Health Informatics Researchers: Identifying the Top Ten Impediments and Solutions” was a systematic review completed by Meslin and team at the IU Center for Bioethics. Some unanticipated but welcome consequences of Meslin’s work on this issue include an invitation to become a member of the Council for Big Data, Ethics, and Society of the Data and Society Institute and a member of the Safe Harbor Team/Regulatory Ethics Working Group of the Global Alliance for Genomics and Health.

Indiana Patient Notification Pilot Study

CLEAR co-director Stan Crosley provided an analysis of the study phase of patient device data flow, including the legal and regulatory aspects of the data movement in both the HIPAA-covered environment and the non-HIPAA environment. Investigators also reviewed and provided assessment of the informed-consent process as it relates to the actual data flow and what might have been anticipated by the patients.

Health Innovation Privacy

CLEAR co-director Stan Crosley was responsible for convening CLEAR’s third annual health innovation privacy conference, entitled “IU CLEAR and IAPP Health Privacy Clinic,” on September 17, 2014, in San Jose, California. The conference focused on the concepts of critical data use and critical data privacy and security protections and included presentations by executives from GE Healthcare, PWC, Booz Allen & Hamilton, Intel, Acxiom, the law firm of Morrison & Forster, the law firm of Drinker Biddle & Reath, and CLEAR co-directors Fred H. Cate and Stan Crosley.

Data Analytics

CLEAR initiatives on data analytics focused on opportunities to incorporate data into healthcare to provide benefits to patients and researchers. CLEAR co-director Stan Crosley focused on opportunities within the quantified-self movement focusing on sensor-based health data and a “Patients like Me” type of analysis, and CLEAR also brought in key stakeholders in the data analytics world, including Acxiom, Eli Lilly and Company, Abbott, Amgen, 3M, staff of a prominent interventional cardiologist/clinical investigator, and Indiana University focusing on the value of an analytics-based approach within the healthcare industry and potential benefits to patients and researchers.

OECD Collaboration/Risk Project

In 2013 CLEAR co-directors Fred H. Cate and Stan Crosley were appointed to the OECD’s Advisory Panel of Experts on Health Information Infrastructure to create an evidence-based, practical framework of privacy interests and risks in health research and practice. Work on this included a workshop with Microsoft focusing on appropriate use of data, the development of several case studies related to collection and use of health data, and the creation of a white paper highlighting the potential for a “use-based” model of health information governance.

Privacy Concerns of Peer-Based Home-Based Technologies

CLEAR co-director Kay Connelly collaborated on a project with the IU School of Informatics and Computing to focus on data sharing and privacy amongst older adult peers. Specifically, the project sought to develop peer-based technologies that supported older adults in staying in their homes for as long as possible by allowing to share information with older adult peers that could improve quality of life such as  wake up time, how much they move around their house, and “errand” information in order to coordinate trips between older adult peers.

Rare Disease Project

CLEAR co-director, Kay Connelly conducted research with patients with rare disease to identify how technology could assist them, with interviews indicating a need for tools to help them communicate with a wide-variety of people, including doctors, family members and friends.

Comprehensive Health Regulations Project

CLEAR created an interactive database of the health care regulatory landscape, including laws and regulations at the federal and state level that affect the creation, use, movement, and maintenance of health information. The project covered laws and regulations governing the processing and use of health data, including bio- and tissue-banking, genetic data, health information breach data and research data restrictions.

Health Information Mapping Project

CLEAR worked with health care organizations and stakeholders to map the generation, use, and destruction of health information and assess the value at the time of the data creation, the initial use of the data, other uses made of the data, and the entities benefiting from such creation and use. This was compiled into a Health Information Map.

Centerstone Research Institute Collaboration

CLEAR and the Centerstone Research Institute, the research arm of the nation’s largest not-for-profit provider of mental health services, collaborated  to investigate how information technology can be used with mental health patients to improve diagnosis and treatment. Specifically, the project focused on how cell phones, PDAs, and other common devices that measure location or motion can be used to provide patients and providers with reliable, quantified information that may be useful in determining treatments and measuring their success., while also considering important issues about privacy, consent, and the applicability of health data regulations to such information.

Protecting Privacy in Health Research Project

CLEAR assembled a blue-ribbon panel of experts in medical research, privacy, law, ethics and patient advocacy to follow up on the Institute of Medicine’s recommendations to resolve issues between HIPPA and the Common Rule.

Information and Intellectual Property Issues in Health Innovation (HI4)

CLEAR, alongside the Center for Applied Cybersecurity Research (CACR), and the Center for Intellectual Property Research (CIPR), supported the HI4 forum for health innovation industries to discuss approaches to quickly-evolving information-related challenges. The inaugural HI4 forum, held in Chicago in May 2012, addressed the myriad legal, technical, and policy issues facing the health sector as it responds to the Bring Your Own Device movement.

CLEAR NIH panelist authors report backing health info de-identification

A joint paper from Dr. Ann Cavoukian and Dr. Khaled El Emam validated that, contrarty to claims of easy re-identification of personal health data used for research, anonymizing data is a reliable, safe and practical way to protect personal information. The paper entitled, “Dispelling the Myths Surrounding De-Identification: Anonymization Remains a Strong Tool for Protecting Privacy” showed that the re-identification of properly de-identified information is not, in fact, an easy or trivial task, and rather requires concerted effort on the part of skilled technicians. De-identification is a vital first step in protecting privacy, by drastically reducing the risk that personal information will be used or disclosed for unauthorized or malicious purposes.

Publications

Cate, F.H. Protecting Privacy in a World of Big Data: The Role of Risk Management, Centre for Information Policy Leadership (2015).

Cate, F.H. “The data protection credibility crisis,” International Data Privacy Law, vol. 5, no. 3 at 161 (2015) (with C. Kuner, C. Millard, D. Svantesson & O. Linskey)

Campbell, B., Caine, K., Connelly, K., Doub, T., & Bragg, A. Cell Phone Ownership and Usage Among Mental Health Outpatients in the US. Personal and Ubiquitous Computing 19, no. 2 (2015): 367-378.

Connelly K, ur Rehman Laghari K, Mokhtari M, Falk T, H, Approaches to Understanding the Impact of Technologies for Aging in Place: A Mini-Review. Gerontology 2014; 60:282-288

Garg, Vaibhav, L. Jean Camp, Lesa Lorenzen-Huber, Kalpana Shankar, and Kay Connelly. Privacy concerns in assisted living technologies. In annals of telecommunications-annales des télécommunications 69, no. 1-2 (2014): 75-88.

Welch, J. L., Astroth, K. S., Perkins, S. M., Johnson, C. S., Connelly, K., Siek, K. A., Jones, J. and Scott, L. L. (2013), Using a mobile application to self-monitor diet and fluid intake among adults receiving hemodialysis. In Journal of Research in Nursing Health, 36: 284–298. doi: 10.1002/nur.21539Update

Daniel O Kutz, Kalpana Shankar, Kay Connelly (2013). Making sense of mobile and web-based wellness information technology: a cross-generational study. In Journal of Medical and Internet Research (JMIR), 15:5. http://www.jmir.org/2013/5/e83/

Jane Kaye, Eric M. Meslin, Bartha M. Knoppers, Eric T. Juengst, Mylène Deschênes, Anne Cambon-Thomsen, Donald Chalmers, Jantina De Vries, Kelly Edwards, Nils Hoppe, Alastair Kent, Clement Adebamowo, Patricia Marshall, and Kazuto Kato. ELSI 2.0 for Genomics and Society, Science , 2012

K. Shankar, L. Jean Camp, Kay Connelly, L. Lorenzen-Huber. Aging, Privacy, and Home-Based Computing: Development of a Framework for Design, IEEE Pervasive Computing, 2012

Fred H. Cate (with Viktor Mayer-Schonberger) Notice and Consent in a World of Big Data, Technology Academics Policy Blog, 2012

Kay Connelly, K.A. Siek, B. Chaudry, J. Jones, K. Astroth, J.L. Welch. An Offline Mobile Nutrition Monitoring Intervention for Varying Literacy Patients Receiving Hemodialysis: A Pilot Study Examining Usage and Usability, Journal of the American Medical Informatics Association, 2012

J.L. Hall, R.J. Palacio, Eric M. Meslin. Genetics and Coronary Heart Disease, Coronary Heart Disease: Clinical, Pathological, Imaging and Molecular Profiles, 2012

A.U. Mutsuddi and Kay Connelly Text Messages for Encouraging Physical Activity: Are They Effective After the Novelty Effect Wears Off?, Pervasive Computing Technologies for Healthcare (PervasiveHealth), 2012

Fred H. Cate (with Viktor Mayer-Schonberger). Notice and Consent in a World of Big Data, Microsoft Corporation, 2012

D. Croft, S.J. Jay, Eric M. Meslin, M.M. Gaffney, J.D. Odell. Perspective:  Is It Time for Advocacy Training in Medical Education?, Academic Medicine, 2012

K. ur Rehman Laghari, N. Crespi, and Kay Connelly. Towards Total Quality of Experience: QoE Model in Communication Ecosystem, IEEE Communications Magazine, 2012

R.K. Pappas, B.N. Gakinya, S. Martino, J.B. Baliddawa, K.J. Bryany, Eric M. Meslin, J.E. Sidle. Ethical Issues in a Stage 1 Cognitive-behavioral Therapy Feasibility Study and Trial to Reduce Alcohol Use Among HIV-infected Outpatients in Western Kenya, Journal of Empirical Research in Human Research Ethics, 2012

Chadwick, R; Ten Have H; Meslin, EM. Health Care Ethics in an Era of Globalization, The SAGE Handbook of Health Care Ethics, 2011

Hazelwood, W; Connelly, K; and Stolterman, E. Issues of Evaluating Ambient Displays In the Wild: Two Case Studies, CHI, 2011

Were, MC, and Meslin, EM. Ethics of Implementing Electronic Health Records in Developing Countries: Points to Consider, AMIA Annu Symp Proc. 2011, 2011

Beenish, C; Connelly, K; Siek, K; Welch, Janet. The Design of a Mobile Portion Size Estimation Interface for a Low Literacy Population, 5th International Conference on Pervasive Computing Technologies for Healthcare, 2011

Cornetta, K; Meslin, EM. Ethical and Scientific Issues in Gene Therapy and Stem Cell Research, The SAGE Handbook of Health Care Ethics, 2010

Meslin, EM; Schwartz, PH. To Be Or Not To Be–A Research Subject?, Surviving Health Care: A Manual for Patients and Their Families, 2010

Cate, Fred H. Protecting Privacy in Health Research, California Law Review, 2010

Meslin, EM. The Value of Using Top-Down and Bottom-Up Approaches for Building Trust and Transparency in Biobanking, Public Health Genomics, 2010

Meslin, EM. Problem Solvers: What to Expect from Our New Bioethics Commission, Science Progress, 2010