Part IQuestions of Data Governance for Data from Digital Home Health Products

1. Introduction

   Carmel Shachar

2. 1In the Medical Privacy of One’s Own Home: Four Faces of Privacy in Digital Home Health Care

   Barbara J. Evans

3. 2Patient Access to Health Device Data: Toward a Legal Framework

   Charles Duan and Christopher J. Morten

4. 3Challenges of Remote Patient Care Technologies under the General Data Protection Regulation: Preliminary Results of the TeNDER Project

   Danaja Fabcic Povse

5. 4Renegotiating 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 IIDigital Home Diagnostics for Specific Conditions

1. Introduction

   Daniel B. Kramer

2. 5Patient Self-Administered Screening for Cardiovascular Disease Using Artificial Intelligence in the Home

   Patrik Bächtiger, Mihir A. Kelshiker, Marie E. G. Moe, Daniel B. Kramer, and Nicholas S. Peters

3. 6The Promise of Telehealth for Abortion

   Greer Donley and Rachel Rebouché

4. 7Monitoring (on) Your Mind: Digital Biomarkers for Alzheimer’s Disease

   Claire Erickson and Emily A. Largent

Part IIIThe Shape of the Elephant for Digital Home Diagnostics

1. Introduction

   I. Glenn Cohen

2. 8Physician and Device Manufacturer Tort Liability for Remote Patient Monitoring Devices

   David A. Simon and Aaron S. Kesselheim

3. 9Post-Market Surveillance of Software Medical Devices: Evidence from Regulatory Data

   Alexander O. Everhart and Ariel D. Stern

4. 10Labeling of Direct-to-Consumer Medical Artificial Intelligence Applications for “Self-Diagnosis”

   Sara Gerke

5. 11“Internet Plus Health Care” as an Impetus for China’s Health System Reform

   Zhang Yi and Wang Chenguang

Part IVReimbursement Considerations for Digital Home Health

1. Introduction

   Julia Adler-Milstein

2. 12A Pathway for High-Value Home Hospital Care in the United States: Statutory, Reimbursement, and Cybersecurity Strategies in the Age of Hybrid Care

   Stephanie Zawada, Nels Paulson, Margaret Paulson, Michael Maniaci, and Bart Demaerschalk

3. 13Digitally Enabled Medicaid Home and Community-Based Services

   Kathryn Huber and Tara Sklar

4. 14EU In-Home Digital Diagnostics – Cross-Border Patient Reimbursement under Threat?

   Kaat Van Delm