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Digital Health Care outside of Traditional Clinical Settings: Ethical, Legal, and Regulatory Challenges and Opportunities

Digital Health Care outside of Traditional Clinical Settings: Ethical, Legal, and Regulatory Challenges and Opportunities

Author: I. Glenn Cohen; Daniel B. Kramer; Julia Adler-Milstein; Carmel Shachar
Publisher: Cambridge University Press
ISBN: 9781009373265
Published In: May 2024
Format: Paperback
Jurisdiction: U.K. ? Disclaimer:
Countri(es) stated herein are used as reference only

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Health care delivery is shifting away from the clinic and into the home. Even prior to the COVID-19 pandemic, the use of telehealth, wearable sensors, ambient surveillance, and other products was on the rise. In the coming years, patients will increasingly interact with digital products at every stage of their care, such as using wearable sensors to monitor changes in temperature or blood pressure, conducting self-directed testing before virtually meeting with a physician for a diagnosis, and using smart pills to document their adherence to prescribed treatments. This volume reflects on the explosion of at-home digital health care and explores the ethical, legal, regulatory, and reimbursement impacts of this shift away from the 20th-century focus on clinics and hospitals towards a more modern health care model.

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