Evidence Con

24.02.|15:00-17:50 Uhr

Evidence Con

Germany’s DiGA Fast-Track creates a new pathway for digital healthcare tools that comes along with a set of new evidence requirements, specifically designed to fit the assessment of digital products.

mit Prof. Dr. Richard Platt, Prof. Dr. Silvia Schneider, Dr. Wiebke Löbker, Dr. Barbara Höfgen, Bakul Patel | Moderation: Jennifer Goldsack, Dr. Ariel Stern, Julia Hagen
Livestream

Links to some of hih and DiMe’s favourite resources:

Want to see the future of digital health tools? Look to Germany. (Harvard Business Review)

Rethinking Clinical Trials: A Living Textbook of Pragmatic Clinical Trials (U.S. National Institutes of Health Research Collaboratory) 

Digital Medicine: A Primer on Measurement (Digital Biomarkers)

The Playbook: Digital Clinical Measures (Digital Medicine Society)

Harnessing the Power of Real-World Evidence (RWE): A Checklist to Ensure Regulatory-Grade Data Quality (Clinical Pharmacology and Therapeutics)

Adding Real-World Evidence to a Totality of Evidence Approach for Evaluating Marketed Product Effectiveness (Duke Margolis Center for Health Policy)

Determining Real-World Data’s Fitness for Use and the Role of Reliability (Duke Margolis Center for Health Policy)

Evidence Standards Framework for Digital Health Technologies (National Institute for Health and Care Excellence)

Using Big Data to Emulate a Target Trial When a Randomized Trial Is Not Available (American Journal of Epidemiology)

Germany’s digital health reforms in the COVID-19 era: lessons and opportunities for other countries (npj Digital Medicine)

Additional Resources on the Sentinel Program (related to Dr. Platt’s presentation):

FDA-Catalyst—Using FDA’s Sentinel Initiative for large-scale pragmatic randomized trials: Approach and lessons learned during the planning phase of the first trial (Clinical Trials) 

Underuse of oral anticoagulants in privately insured patients with atrial fibrillation: A population being targeted by the IMplementation of a randomized controlled trial to imProve treatment with oral AntiCoagulanTs in patients with Atrial Fibrillation (IMPACT-AFib) (American Heart Journal) 

Bystander Ethics and Good Samaritanism: A Paradox for Learning Health Organizations (The Hastings Center Report)