RT @tomleblancMD: "Data empathy" - an overdue concept in #healthIT and #bigdata work. Below is essential reading on key considerations in #….

RT @SarahKarlin: .@DrAbernethyFDA departing advice on FDA leadership hole.

Generate videos in just a few seconds. Try Grok Imagine, free for a limited time.

As for my next steps. I am going to spend some time with my family and do some brainstorming, reading & writing. I’ll be back at it soon, but in the meantime, I am just so grateful to everyone @US_FDA for trusting me to help advance the agency’s mission. 5/5.

If COVID has taught us anything, it’s that we need to rethink US digital health infrastructure. This transformation will require new ways of working across traditional silos in government & business/tech, ensuring we always put patients first. 4/5.

A thank you to all who came before me, mentors & colleagues who encouraged me to take this position, & who also helped me make the considered decision to leave once I knew we had all of the elements in place for continued growth. I am so honored to have had your wise counsel.3/5.

Thank you to @DrWoodcockFDA for your guidance, your leadership, and your unwavering focus on safety and efficacy in service of the patient. The country has been well-served and in excellent hands with you as our acting Commissioner. 2/5.

The last 2+ yrs @US_FDA have been some of the most explorative & enlightening of my career. We stood up the tech & data modernization programs, helped launch the #COVID19 Evidence Accelerator, made real progress in big areas like CBD. the list goes on.1/5

RT @DrWoodcockFDA: By unleashing the power of real-world evidence, we can accelerate medical product development and bring new innovations….

RT @DrWoodcockFDA: Our new Data Modernization Action Plan is great news for the agency, public health and our stakeholders & it’s the next….

FDA’s Data Modernization Action Plan leverages the foundations laid by our Technology Modernization Action Plan: a modern, cloud-forward technical infrastructure; a product-oriented approach and enhanced collaboration. #FDAVoices

FDA is focused on data & tech modernization that supports real-time analyses to inform regulatory work. E.g., yesterday we launched part 2 of a pilot to use AI to enhance our ability to identify violative imported seafood products ("stinky fish").

Kevin Fu has joined FDA as an expert in residence, our first acting director of medical device cybersecurity in the Center for Devices and Radiological Health (CDRH). Welcome to the FDA team. #becybersmart #cybersecurity.

Cybersecurity isn't just a tech issue - it is a health issue. Health tech has cyber-risks. Many medical devices include software and can connect to the internet; they are at risk of security breaches. FDA has many efforts to reduce risk. #becybersmart

Top line summary from this updated FDA guidance is that patients who receive COVID vaccines & other medical products authorized under EUA do not need to be excluded from clinical trials of investigational products. Great news for patients! There are caveats, so read the guidance.

FDA updated the guidance on conduct of clinical trials during this pandemic. New Q#27 addresses whether receipt of a vaccine or other COVID-19 medical product authorized under EUA automatically excludes a person from any other clinical trial.

RT @DrWoodcockFDA: FDA has completed our investigation of the 2020 leafy greens E.coli outbreak. We found the presence of a recurring strai….

RT @DrWoodcockFDA: Producing or distributing drugs that don’t meet FDA quality standards poses a serious risk of harm to patients. This wil….

National Library of Medicine's Pubmed, released in 1996, is a great example of how government action accelerates progress. Pubmed made searching the medical literature easy and free - a catalytic event in the application of research-based evidence to patient care. @FNLM #EBM.

Real-world data/evidence (RWD/E) isn't a new field rather an updated name/concept for an evolving field & specific areas of focus. Observational/outcomes research -> comparative effectiveness research/ pharmacoepidemiology -> patient-centered outcomes research/etc -> RWD/E.

Real-world data/evidence is the contemporary iteration of observational research (OR) / outcomes research / clinical epidemiology. The name evolved as data/analytic capabilities evolved, the focus of the research question shifted, and new outcomes were variables added.