CONTEXT: Proposed Modifications to the HIPAA Privacy Rule to Support, and Remove Barriers to, Coordinated Care and Individual Engagement |US Only IMPACT: Low Quality Level Mean [1 – 10]: 5 1. “The proposed Continue Reading
CONTEXT: This is a great article on just how valuable RWR / RWE is becoming for regulators worldwide as they will invariably follow the FDA’s lead | Be honest if the Continue Reading
CONTEXT: Opinion piece on the developing FDA guidance and legislation to come on medical devices. This I going to be especially interesting for SaaMDs and AI in medical devices. IMPACT: Continue Reading
CONTEXT: USA | Office for Human Research Protections (OHRP) has released a new informational video to help parents understand the importance [and implications] of Paediatric Research | Just as a Continue Reading
CONEXT: Denmark | De-Centralised Trials | Regulatory Update | RWR and Regulators | RWR IMPACT: Regulator endorsed initiative for de-centralised trials|Making clinical research results more ‘real’ READ TIME: 2.5 mins Continue Reading
CONTEXT: RWR & Regulators | Regulatory Updates | RWR | Ireland | Retrospective Chart Reviews IMPACT: High = New regulatory framework to support (improve?) the conduct of retrospective chart reviews Continue Reading
Comments – Part of the EMA’s continued commitment to RWE in support of medicinal product utilisation. When you see regulators investing in infrastructure like this, you know they are serious Continue Reading
Quick Notes: CONTEXT: USA, IVDs, RWE, Real-World Evidence Framework for regulatory decision-making for in vitro diagnostics (IVDs) IMPACT: step forward in providing the valuable information that IVD manufacturers and others Continue Reading
Quick Notes: CONTEXT: Japan, Real-World Data IMPACT: Acceptability of RWD in Regulatory Submissions Time to Read = 2 mins Quotes from Source: 1. “TOKYO — Japan’s health ministry will issue Continue Reading
