Digital Health Care outside of Traditional Clinical Settings

I. Glenn Cohen is the James A. Attwood and Leslie Williams Professor of Law at Harvard Law School. He is one of the world's leading experts on the intersection of bioethics and the law, as well as health law. He is the author of more than 150 articles and the author, editor, or co-editor of more than fifteen books. Daniel B. Kramer is a clinical cardiac electrophysiologist at Beth Israel Deaconess Medical Center and Associate Professor of Medicine at Harvard Medical School. His research focuses on bioethics, health policy, and clinical outcomes related to the use of cardiovascular devices and procedures. Julia Adler-Milstein is Professor of Medicine at University of California, San Francisco. Her work – more than 200 scholarly articles and book chapters – sits at the intersection of health policy and health informatics. In particular, she has examined how emerging technologies are shaping opportunities to improve diagnostic processes and outcomes. Carmel Shachar is Assistant Clinical Professor of Law and the Faculty Director of the Health Law and Policy Clinic at Harvard Law School. She was previously Executive Director of Harvard Law's Petrie-Flom Center. Her work focuses on access to care and digital health and she is the co-editor of several volumes including Transparency in Health Care and Disability, Law, Health, and Bioethics.

'… provides a roadmap toward a twenty-first-century medical model … Recommended.' B. A. D'Anna, CHOICE

• Introduction Carmel Shachar, Julia Adler-Milstein, Daniel B. Kramer and I. Glenn Cohen; Part I. Questions of Data Governance for Data from Digital Home Health Products: Introduction Carmel Shachar; 1. In the Medical Privacy of One's Own Home: Four Faces of Privacy in Digital Home Health Care Barbara J. Evans; 2. Patient Access to Health Device Data: Toward a Legal Framework Charles Duan and Christopher J. Morten; 3. Challenges of Remote Patient Care Technologies Under the General Data Protection Regulation: Preliminary Results of the TeNDER Project Danaja Fabcic Povse; 4. Renegotiating the Social Contract for Use of Health Information: Lessons Learned from Newborn Screening and Implications for At-Home Digital Care Jodyn Platt and Sharon Kardia; Part II. Digital Home Diagnostics for Specific Conditions: Introduction Daniel B. Kramer; 5. Patient Self-Administered Screening for Cardiovascular Disease Using Artificial Intelligence in the Home Patrick Bächtiger, Mihir A. Kelshiker, Marie E. G. Moe, Daniel B. Kramer and Nicholas S. Peters; 6. The Promise of Telehealth for Abortion Greer Donley and Rachel Rebouché; 7. Monitoring (on) Your Mind: Digital Biomarkers for Alzheimer's Disease Claire Erickson and Emily A. Largent; Part III. The Shape of the Elephant for Digital Home Diagnostics in the Market: Introduction I. Glenn Cohen; 8. Physician and Device Manufacturer Tort Liability for Remote Patient Monitoring Devices David A. Simon and Aaron S. Kesselheim; 9. Post-Market Surveillance of Software Medical Devices: Evidence from Regulatory Data Alexander O. Everhart and Ariel D. Stern; 10. Labeling of Direct-to-Consumer Medical Artificial Intelligence Applications for 'Self-Diagnosis' Sara Gerke; 11. 'Internet Plus Health Care' as an Impetus for China's Health System Reform Wang Chenguang and Zhang Yi; Part IV. Reimbursement Considerations for Digital Home Health: Introduction Julia Adler-Milstein; 12. A Pathway for High-Value Home Hospital Care in the US: Statutory, Reimbursement, and Cybersecurity Strategies in the Age of Hybrid Care Stephanie Zawada, Nels Paulson, Margaret Paulson, Michael Maniaci and Bart Demaerschalk; 13. EU Cross-Border In-Home Digital Diagnostics: Patient Reimbursement Under Threat? Kaat Van Delm; 14: Digitally Enabled Medicaid Home and Community-Based Services Kathryn Huber and Tara Sklar.