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Graphic image of doctor on laptop screen, and patient on phone screen.

The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School is engaged in a three year initiative that examines the ethical, social, and legal challenges of digital home health products, with a focus on home diagnosis of infectious and chronic conditions. Launched in early 2021 and supported by the Gordon and Betty Moore FoundationDiagnosing in the Home: The Ethical, Legal, and Regulatory Challenges and Opportunities of Digital Home Health will seek to develop scholarship, guidelines, and proposed regulations for the ethical implementation of digital products that support clinical diagnosis in patients’ homes.

Background

With the COVID-19 pandemic, health care delivery is 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.” Since older individuals are extremely vulnerable to COVID-19, with outbreaks in nursing facilities driving a significant number of pandemic deaths, the virus has prompted increasing interest in allowing seniors to age at home. Similarly, there is pressure to keep patients out of the clinic as much as possible, perhaps by using technologies such as smart pills for diagnostics, patient monitoring, and adherence. 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.

While the move towards digital home health predates COVID-19, the pandemic represents an opportunity to rethink the delivery of care, 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 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.

Unfortunately, to date, most of the scholarship and implementation has focused on translating ongoing and existing models of care into digital home health. As patients use digital home health to diagnose conditions and receive treatment, the health system will need to answer ethical questions raised and to develop a new regulatory approach to govern digital home health.

Our vision for a learning health care system is one that embraces the potential of digital home health products to support diagnoses, improve care, encourage caregivers, maximize pandemic resilience, and allow individuals to stay within the home when preferable. The Petrie-Flom Center will develop scholarship, guidelines, and proposed regulations for the ethical implementation of these products, using focus groups, virtual workshops, and interdisciplinary scholarship.

The Project

While the promise of digital home health is undeniable, like all technologies, there are ethical, legal, and regulatory questions raised by its adoption. Diagnosing in the Home will focus on articulating a regulatory and ethical framework for a 21st century approach to diagnosis, utilizing digital health technologies to their fullest potential.

The project seeks to answer important digital home health questions, such as:

  • Access and equity: If digital home health requires a smartphone or other device as a prerequisite to use, to what extent will disparities in access to those technologies lead to disparities in health outcomes?

  • Social interconnectedness: Will the physician-patient relationship be undermined if they are never physically in the same room? Will physicians be expected to monitor rivers of patient data constantly, to proactively flag or diagnose conditions, instead of waiting until the patient schedules an appointment?

  • Patient Privacy: Employers and schools are asking for people to report their health status each morning, but how will this data get shared and be used? How do we design home health products to reflect the importance of privacy while still utilizing the data generated by these products?

Diagnosing in the Home seeks to answer these questions by: conducting a literature review of legal and ethical works on digital health; completing a regulatory scan to identify which regulatory statutes are relevant to the implementation of digital home health; using an interdisciplinary Delphi panel to generate ethical guiding principles and best practices for diagnostic digital home health; articulating model regulation to support diagnostic digital home health; engaging with key stakeholders and thought leaders on this subject through our steering committee, events, and the Delphi panel; and educating scholars, policymakers, providers, patient advocates, and the public via virtual events, conferences, podcasts, and digital symposia.

Project Publications

Diagnosing in the Home:The Ethical, Legal, and Regulatory Challenges and Opportunities of Digital Home Health
Contributors: David A. Simon, Carmel Shachar, Chloe Reichel, Laura Chong, I. Glenn Cohen 

Regulatory Roadmap for Digital Diagnostics
Contributors: David A. Simon, Carmel Shachar, Susannah Baruch, Chloe Reichel, Laura Chong, & I. Glenn Cohen


Project Leadership


This research is supported by the Gordon and Betty Moore Foundation (grant agreement number 9974).

Read "Diagnosing in the Home: The Ethical, Legal, and Regulatory Challenges and Opportunities of Digital Home Health."
Read "Regulatory Roadmap for Digital Diagnostics."