This volume reflects on the recent explosion of at-home digital health care. It explores the ethical, legal, and regulatory 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.
This volume reflects on the recent explosion of at-home digital health care. It explores the ethical, legal, and regulatory 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.
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.
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.
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