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June 15, 2022, 9am-5pm

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Conference Description

Even prior to the COVID-19 pandemic, health care delivery was already shifting away from the clinic and into the home, utilizing telehealth, wearable sensors, ambient surveillance, and other products. The COVID-19 pandemic has shown the value of when “health care comes home.” Trends such as facilitating aging at home for seniors, keeping patients out of the clinic as much as possible, and telehealth have only been accelerated by the pandemic. For example, telehealth made up 50% of all physician visits in mid-April 2020 in response to the pandemic, and continues to grow far past pre-pandemic rates.

We are currently in a unique position to reflect on the 2020-21 explosion of at-home digital health care and to think through the ethical and legal challenges and opportunities of this shift, finally leaving the 20th century focus on the clinic and the hospital for a more modern model. Patients will increasingly interact with digital products from the start of their care, using wearable sensors to monitor changes in temperature or blood pressure, conducting home or self-directed testing before virtually meeting with a physician for a diagnosis, and then using smart pills to document their adherence to the prescribed treatment. Some of these products may be direct to consumer while others will be designed to be integrated into the existing health care system. Some medical care may be relatively easier to translate from the clinic to the home due to factors, such as pre-existing clinician/patient relationships. Other services, such as diagnostics, may prove more complicated to shift into the home.

This year’s conference is organized in collaboration with Julia Adler-Milstein, Professor of Medicine and Director of the Center for Clinical Informatics and Improvement Research at University of California San Francisco, and Daniel Kramer, Assistant Professor of Medicine at Beth Israel Deaconess Medical Center.

Online Viewing

  • Watch our contributors discussing their research on YouTube

Agenda

9-9:15am, Welcome Remarks 

  • Julia Adler-Milstein, Professor of Medicine and Director of the Center for Clinical Informatics and Improvement Research at University of California San Francisco
  • I. Glenn Cohen, Petrie-Flom Center Faculty Director, James A. Attwood and Leslie Williams Professor of Law, and Deputy Dean, Harvard Law School
  • Daniel B. Kramer, National Heart & Lung Institute, Imperial College London, Imperial College Healthcare NHS Trust, Assistant Professor of Medicine, Beth Israel Deaconess Medical Center, and Harvard Medical School
  • Carmel Shachar, Executive Director, The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School

9:15-10:30am, Data Privacy and home diagnostics

  • Charles Duan, Senior Fellow, R. Street Institute and Senior Policy Fellow, Program on Information Justice and Intellectual Property, American University Washington College of Law and Christopher Morten, Associate Clinical Professor of Law, Columbia Law School and Visiting Fellow, Yale Law School - Toward A Legal Framework for Patient Access to At-Home Health Care Device Data
  • Danaja Fabcic Povse, Doctoral Researcher, Health and Aging Law Lab (HALL) Law, Science, Technology and Society Research Group (LSTS), Vrije Universiteit Brussel (VUB) - Challenges of alert-systems for remote patient care in the EU legal framework: data protection, cybersecurity and medical devices regulation
  • Barbara Evans, Professor of Law, Professor of Engineering, and Stephen C. O’Connell Chair, University of Florida - In the [Medical] Privacy of One’s Own Home: Four Faces of Privacy in Digital Home Health Care
  • Moderator: Carmel Shachar, Executive Director, The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School

10:30-10:45am, Break

10:45am-12:15pm, Digital home diagnostics for specific conditions

  • Patrik Bächtiger, National Heart & Lung Institute, Imperial College London; Mihir A. Kelshiker, National Heart & Lung Institute, Imperial College London, Imperial College Healthcare NHS Trust; Marie E. G. Moe, National Heart & Lung Institute, Imperial College London, Norwegian University of Science and Technology; Daniel B. Kramer, National Heart & Lung Institute, Imperial College London, Imperial College Healthcare NHS Trust, Beth Israel Deaconess Medical Center and Harvard Medical School; and Nicholas S. Peters, National Heart & Lung Institute, Imperial College London, Imperial College Healthcare NHS Trust - Patient Self-administered Screening for Cardiovascular Disease Using Artificial Intelligence in the Home
  • Greer Donley, Assistant Professor of Law, University Pittsburgh Law School and Rachel Rebouche, Interim Dean and James E. Beasley Professor of Law, Temple University Beasley School of Law - “Telabortion:" Virtual Care for Medication Abortion and the Future of Abortion Access
  • Emily Largent, Emanuel & Robert Hart Assistant Professor, Department of Medical Ethics and Health Policy, Perelman School of Medicine, University of Pennsylvania - Monitoring (on) Your Mind: Ethical and Legal Implications of Monitoring Older Adults for Alzheimer’s Disease
  • Jodyn Platt, Assistant Professor, Division of Learning and Knowledge Systems, Department of Learning Health Sciences,University of Michigan Medical School Home - Renegotiating the social contract for use of health information: Lessons learned from newborn screening and implications for at-home digital care
  • Moderator: Daniel B. Kramer, National Heart & Lung Institute, Imperial College London, Imperial College Healthcare NHS Trust, Assistant Professor of Medicine, Beth Israel Deaconess Medical Center, and Harvard Medical School

12:15-1:45pm, Break

1:45-3pm, The Business of digital home health

  • David A. Simon, Research Fellow, Digital Home Health, Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School and Aaron Seth Kesselheim, Professor of Medicine, Harvard Medical School and faculty member, Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women’s Hospital - Physician & Manufacturer Liability for Remote Monitoring and Diagnostics
  • Ariel Stern, Poronui Associate Professor of Business Administration, Harvard Business School and Alexander Everhart, Postdoctoral Research Fellow, Harvard-MIT Center for Regulatory Science, Harvard Medical School - Post-market surveillance of software medical devices: evidence from regulatory data
  • Kaat Van Delm, PhD Researcher, Leuven Institute for Healthcare Policy (LIHP), KU Leuven - Reimbursement challenges for cross-border at-home diagnostics in the EU
  • Moderator: I. Glenn Cohen, Petrie-Flom Center Faculty Director, James A. Attwood and Leslie Williams Professor of Law, and Deputy Dean, Harvard Law School

3-3:30pm, Break

3:30-4:45pm, Reimbursement considerations for digital home health

  • Kathryn Huber, Resident Physician, Internal Medicine Program, University of Colorado and Professor of Practice in Law, James E. Rogers College of Law, University of Arizona and Tara Sklar, Professor of Health Law and Director, Health Law & Policy Program, James E. Rogers College of Law, University of Arizona, Faculty Senior Advisor, Telehealth Law & Policy, Arizona Telemedicine Program, UA College of Medicine-Tucson, and Faculty Senior Advisor, Innovations in Healthy Aging at University of Arizona Heath Sciences - Modernizing Medicaid Home and Community-Based Services with At-Home Diagnostics and Home Telehealth
  • Sara Gerke, Assistant Professor of Law, Penn State Dickinson Law - Labeling of Direct-To-Patient/Consumer Medical Artificial Intelligence Applications for “Self-Diagnosis”
  • Stephanie Zawada, Mayo Clinic College of Medicine and Science; Nels Paulson, Social Sciences Department, University of Wisconsin; Margaret Paulson, Division of Hospital Internal Medicine, Mayo Clinic Health System; Michael Maniaci, Division of Hospital Internal Medicine, Mayo Clinic; and Bart Demaerschalk, Mayo Clinic Center for Digital Health - A Pathway for High-Value Home Hospital Programs: Statutory, Reimbursement, and Community-Building Strategies in the Digital Age
  • Moderator: Julia Adler-Milstein, Professor of Medicine and Director of the Center for Clinical Informatics and Improvement Research at University of California San Francisco

4:45-5pm, Closing Remarks


Sponsored by the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School, with support from the Oswald DeN. Cammann Fund at Harvard University.


Video

PLAYLIST: 2022 Petrie-Flom Center Annual Conference: Diagnosing in the Home

Tags

bioethics   biotechnology   health information technology   health law policy   public health   regulation