Digital Medicine: clinical opportunities, regulatory transformation, and barriers to adoption
Digital Medicine: clinical opportunities, regulatory transformation, and barriers to adoption
May 14, 2019
Invitation Only
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Draft Agenda
Please note that the conference agenda has not been finalized and is subject to change. All sessions will take place in Chao Hall, Room 340.May 14
8:30-9:00 | Check-in & Breakfast |
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9:00-9:15 | Overview, Welcome, Introduction to the DayAriel Stern, Will Gordon |
9:15-9:30 | Defining Digital MedicineAndy Coravos, Jen Goldsack |
9:30-10:35 | Validation and ResearchWearable Devices in Clinical Trials: Hype and Hypothesis Eric Perakslis Digital Medicine Studies That are Fit for Purpose: An Academic Physician's Perspective Bill Wood Bridging the Divide: Harmonizing Virtual and Site-based Trials Brad Hirsch Machine Learning for Parkinson’s Disease: Identifying Bradykinesia from Wrist Accelerometer Data Ariel Dowling ClinicalTrials.gov: Digital Tools and Evidence Caroline Marra The CTTI Feasibility Studies Database Annemarie Forrest Wearables and Algorithms: What We Know and What We Don't Jessilyn Dunn Panel Discussion Eric Perakslis, Bill Wood, Brad Hirsch, Ariel Dowling, Caroline Marra, Annemarie Forrest, Jessilyn Dunn |
10:35-10:50 |
Coffee Break |
10:50-11:30 | Informed Consent, Data Rights, PrivacyHealth Privacy and Data Rights: An Evolving Landscape Deven McGraw Real-world Evidence in Research Studies – Data Rights and Privacy When Research is Integrated into Daily Life Lara Mangravite Evaluating Mental Health Apps: Translating Theory into Practice Liza Hoffman Panel Discussion Deven McGraw, Lara Mangravite, Liza Hoffman |
11:30-12:00 | CybersecurityMedical Device Cybersecurity Seth Carmody Biohacking Village @ DEF CON, Security Research, and #WeHeartHackers Nina Alli, Josh Corman Panel Discussion Seth Carmody, Nina Alli, Josh Corman |
12:00-12:40 | Lunch |
12:40-1:10 | Ethics and Legal PerspectivesThe Internet of Bodies Andrea Matwyshyn A Smart Pill to Swallow: Legal and Ethical Issues of Ingestible Electronic Sensors Sara Gerke, Timo Minssen Panel Discussion Andrea Matwyshyn, Sara Gerke, Timo Minssen |
1:10-1:40 | Emerging Frameworks for Safe and Effective TechnologiesThe Recipe for Digital Medicine is Trust, Reliability and Quality Greg Licholai Do We Need a Good Algorithm Practice (GAP) Initiative? Ken Gersing Digital Trials Done Right: Selecting a Meaningful Endpoint & A Matching Technology Pamela Tenearts |
1:40-1:55 | Coffee Break |
1:55-2:25 |
Digital Medicine and the Role of GovernmentImportant Considerations for Successful Qualification Proposals for Digital Technologies Francesca Cerreta A World of Neurosurgical Innovation: Collaborations in Regulatory Science and Digital Health Jon Pomeraniec Software Precertification: A Reimagined Approach Bakul Patel |
2:25-2:45 | The Provider's PerspectiveCreating a Learning Health System Calum MacRae Patient-Generated Data and Electronic Health Records David Bates |
2:45-3:00 | Coffee Break |
3:00-3:10 | Building and Scaling the Commercialization of Digital TherapeuticsJeff Abraham |
3:10-3:40 | Fireside ChatDavid Shaywitz, Robert Califf |
3:40 | Wrap Up |
4:00 | Adjourn |