Tag: digital health

Petrie-Flom Center logo.

Call for Applications: Research Fellow for Diagnostic Digital Home Health

The Petrie-Flom Center Staff Leave a comment

Overview

The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School is hiring a full-time post-doctoral fellow to support its newly launched Diagnostic Digital Home Health initiative. This position will likely be a three year commitment.

This sponsored research project examines the ethical, social, and legal challenges of digital home health products, with a focus on home diagnosis of infectious and chronic conditions. This project will develop scholarship, guidelines, and proposed regulations for the ethical implementation of these products, using focus groups, virtual workshops, and interdisciplinary scholarship, with a focus on considerations of access and equity, social interconnectedness, and patient privacy.

Previous Petrie-Flom Center post-doctoral fellows have used their positions as successful launching pads for tenure-track legal, health policy, and bioethics academic careers. Our most recent post-doctoral fellow has published in leading journals such as JAMA, Science, and the Journal of Law and the Biosciences. She has been interviewed as an expert in biomedical regulation by media outlets such as Forbes and Lancet Digital Health and presented to regulators at the U.S. Department of Health and Human Services.
Read More

Pen hovering over words "I agree" with check box next to it.

Unique Challenges to Informed Consent in Deep Phenotyping Research

The Petrie-Flom Center Staff Leave a comment

By Benjamin C. Silverman

Deep phenotyping research procedures pose unique challenges to the informed consent process, particularly because of the passive and boundless nature of the data being collected and how this data collection overlaps with our everyday use of technology.

As detailed elsewhere in this symposium, deep phenotyping in research involves the collection and analysis of multiple streams of behavioral (e.g., location, movement, communications, etc.) and biological (e.g., imaging, clinical assessments, etc.) data with the goal to better characterize, and eventually predict or intervene upon, a number of clinical conditions.

Obtaining voluntary competent informed consent is a critical aspect to conducting ethical deep phenotyping research. We will address here several challenges to obtaining informed consent in deep phenotyping research, and describe some best practices and relevant questions to consider.

Read More

Telemedicine or telehealth virtual visit / video visit between doctor and patient on laptop computer and mobile phone device.

The Petrie-Flom Center Launches New Project: Diagnosing in the Home

The Petrie-Flom Center Staff Leave a comment

Diagnosing in the Home will seek to examine the ethical, social, and legal challenges of digital home health products, with a focus on home diagnosis of infectious and chronic conditions.

January 27, 2021 – The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School today announced a new research initiative, Diagnosing in the Home: The Ethical, Legal, and Regulatory Challenges and Opportunities of Digital Home Health. This three-year project will seek to promote the translation of diagnostic medical services into home health care through regulatory and ethical frameworks. This initiative is generously supported by a grant from the Gordon and Betty Moore Foundation.

Read More

Code on computer.

How to Secure Our Digital Health Infrastructure Against Cyber Attacks

Vrushab Gowda Leave a comment

By Vrushab Gowda

Our health information infrastructure is highly susceptible to cyber attacks. At the time of writing, the Department of Health and Human Services (HHS) is actively investigating over 700 major breaches over the past 24 months alone.

It is incumbent upon our institutions to proactively guard against these threats, with our federal government leading the charge.

Read More

computer and stethoscope

How Telehealth Could Improve — or Worsen — Racial Disparities

The Petrie-Flom Center Staff Leave a comment

By Craig Konnoth, JD, M.Phil., Wendy Netter Epstein, JD, and Max Helveston, JD

Despite upping the stakes of America’s partisan divide, the pandemic has prompted bipartisan support for at least one cause — the rapid rollout of telehealth, which allows people to see their doctors by videoconference or telephone.

In last week’s executive order, the Trump Administration reaffirmed its commitment to the use of telehealth. While telehealth may be, in many ways, a panacea for access to healthcare, particularly in COVID times, we should be concerned that patients of color may be left behind.

Read More

Washington, USA- January13, 2020: FDA Sign outside their headquarters in Washington. The Food and Drug Administration (FDA or USFDA) is a federal agency of the USA.

A New Step for the FDA in Regulating Digital Health Products

Vrushab Gowda Leave a comment

By Vrushab Gowda

On September 22, the U.S. Food and Drug Administration (FDA) announced the establishment of a new initiative to regulate digital health products – the Digital Health Center of Excellence (DHCoE).

In some ways, the announcement does not come as a surprise; FDA Commissioner Stephen Hahn’s predecessor, Scott Gottlieb, outlined the DHCoE in a press release two years ago. What does remain to be seen is whether DHCoE represents a true paradigm shift in FDA’s approach to regulating digital health products.

According to Hahn, the DHCoE aims to (1) build partnerships, (2) share knowledge across FDA and with stakeholders, and (3) innovate regulatory approaches. It will be led by the current Director of CDRH’s Division of Digital Health, Bakul Patel.

Read More

Crowd of small symbolic 3d figures linked by lines

Why ‘Mandatory Privacy-Preserving Digital Contact Tracing’ is the Ethical Measure Against COVID-19

Cansu Canca Leave a comment

Cross-posted from Medium, where it originally appeared on April 10, 2020. 

By Cansu Canca

Thanks to privacy-by-design technology, population-wide mandatory use of digital contact tracing apps (DCT) can be both more efficient and more respectful of privacy than conventional manual contact tracing, and considerably less intrusive than current lockdowns. Even if counterintuitive, mandatory private-by-design DCT is therefore the only ethical option for fighting COVID-19.

Click here to read the full post on Medium.

(image via higyou / Shutterstock.com)

Photograph from above of a health care provider taking a patient's blood pressure.

Diving Deeper into Amazon Alexa’s HIPAA Compliance

Adriana Krasniansky 1 Comment

By Adriana Krasniansky

Earlier this year, consumer technology company Amazon made waves in health care when it announced that its Alexa Skills Kit, a suite of tools for building voice programs, would be HIPAA compliant. Using the Alexa Skills Kit, companies could build voice experiences for Amazon Echo devices that communicate personal health information with patients. 

Amazon initially limited access to its HIPAA-updated voice platform to six health care companies, ranging from pharmacy benefit managers (PBMs) to hospitals. However, Amazon plans to expand access and has identified health care as a top focus area. Given Thursday’s announcement of new Alexa-enabled wearables (earbuds, glasses, a biometric ring)—likely indicators of upcoming personal health applications—let’s dive deeper into Alexa’s HIPAA compliance and its implications for the health care industry.
Read More