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Digital Health Care outside of Traditional Clinical Settings

Digital Health Care outside of Traditional Clinical Settings

Digital Health Care outside of Traditional Clinical Settings

Ethical, Legal, and Regulatory Challenges and Opportunities
I. Glenn Cohen, Harvard Law School, Massachusetts
Daniel B. Kramer, Harvard Medical School, Massachusetts
Julia Adler-Milstein, University of California, San Francisco
Carmel Shachar, Harvard Law School, Massachusetts
April 2024
Adobe eBook Reader
9781009373227

    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. This title is also available as Open Access on Cambridge Core.

    • Provides a critical analysis of the recent explosion of health care outside of clinical settings
    • Supplies medical providers, policymakers, and other stakeholders with guidance on the impact of at-home digital health care
    • Available as Open Access on Cambridge Core

    Reviews & endorsements

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

    See more reviews

    Product details

    April 2024
    Adobe eBook Reader
    9781009373227
    0 pages
    This ISBN is for an eBook version which is distributed on our behalf by a third party.

    Table of Contents

    • 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.
      Contributors
    • Carmel Shachar, Julia Adler-Milstein, Daniel B. Kramer, I. Glenn Cohen, Barbara J. Evans, Charles Duan, Christopher J. Morten, Danaja Fabcic Povse, Jodyn Platt, Sharon Kardia, Patrick Bächtiger, Mihir A. Kelshiker, Marie E. G. Moe, Nicholas S. Peters, Greer Donley, Rachel Rebouché, Claire Erickson, Emily A. Largent, David A. Simon, Aaron S. Kesselheim, Alexander O. Everhart, Ariel D. Stern, Sara Gerke, Wang Chenguang, Zhang Yi, Stephanie Zawada, Nels Paulson, Margaret Paulson, Michael Maniaci, Bart Demaerschalk, Kaat Van Delm, Kathryn Huber, Tara Sklar