Tool or Resource Type: Governance

A group of experts in cybersecurity, device policy and regulation, and informed consent have collaborated on defining a framework for cybersecurity informed consent (CIC). The goal is to help people understand the cybersecurity issues related to medical devices that can be connected to the internet. Any connected and/or implantable medical device has cybersecurity vulnerabilities, which means they need an informed consent process. In this talk for DEF CON 28, Meg Doerr, principal scientist at Sage Bionetworks, shares context for the need for CIC and how she and her many collaborators are approaching the development of a framework.

Accelerating medical advancements using technologies like artificial intelligence is going to require data — your data, everyone’s data. This talk by Megan Doerr, a principal scientist at Sage Bionetworks, explores how to regain enough trust in our digital neighborhood to make sharing private health data possible (again).

This talk was presented to a local audience at TEDxKC, an independent event.

 

Webinar: Use of E-Consent in Human Subjects Research
Presenter: Megan Doerr, Sage Bionetworks

This is a recording of a webcast presentation to the Office for Human Research Protections (OHRP) on January 30, 2020, as part of their Lunch and Learn initiative to educate their staff. Sage Bionetworks posted this video as an educational resource for the public. It does not represent the position, views, or endorsement of OHRP or the U.S. Department of Health and Human Services.

For more information about informed consent, consult the Elements of Informed Consent. 

 

 

John Wilbanks, Chief Commons Officer of Sage Bionetworks, participated in the panel “Using Patient Data in Research: Balancing Benefits and Risks.” The panel took place during Milken’s Institute’s Future of Health Summit 2019.

We are capturing, tracking, and creating more data than ever about our lifestyle and health. More and more companies hold our data, which we sign away by indicating that we’ve read extensive privacy policies, when few of us actually have. And there are major gaps, loopholes, and complexities in the regulations that protect our data. Yet, when put to good use, these masses of data might help us manage our health, help providers understand the patient experience, and help researchers glean new insights about disease and biology. What risks exist when companies carry so much consumer data? How can good practice and regulations mitigate these risks? Our panel of experts will discuss these issues and lead a conversation about how we can shift towards an environment where health data is used to empower patients, while also being used to glean new insights for research and move the field forward.

Moderator
Erin Mershon
Senior News Editor, STAT

Speakers

Dawn Barry, President and Co-Founder, LunaDNA

Andrea Coravos, Co-Founder and CEO, Elektra Labs

Deven McGraw, Chief Regulatory Officer, Ciitizen

Pamela Powers, Chief of Staff, US Department of Veterans Affairs

John Wilbanks, Chief Commons Officer, Sage Bionetworks

The Mobile Health App Developer Workshop took place at the New York Genome Center on Sept. 12, 2019. Sage Bionetworks hosted the workshop. This talk features Meg Doerr, of Sage Bionetworks, on the Elements of Informed Consent.

Informed Consent in the Era of Digital

Learn from Megan Doerr, Principal Scientist, Governance, about Sage Bionetworks’ Elements of Informed Consent toolkit and review:

• Use cases and real examples describing the Sage approach to the informed consent process, including eConsent.
• Prompt questions to make sure you’ve thought through your approach.
• Sage tools available to you to help support your development of consent documents when using digital medicine tools in research.

The goal of readability analysis is to make copy be understandable by the largest audience possible. Consistency in grade level/reading ease is more important than the average grade level/reading ease.

Sage Bionetworks has developed a novel multi-media approach to addressing transparency and comprehension within electronic informed consent (eConsent) for app-mediated research studies. We deployed this eConsent process in minimal-risk research studies. Here we describe the rationale for the framework selected and best practice for application of the framework in other clinical studies.

Learn about the governance process for the mPower Parkinson disease research study app. mPower is a mobile app-based study piloting new approaches to monitoring key indicators of PD progression and diagnosis by supplementing traditional behavioral symptom measurements with novel metrics gleaned from sensor-rich mobile devices.