David Amor

SaMD regulatory nerd.

[Bakul Patel @_bakulpatel]

Today @US_FDA issued several guidances that address key provisions of the 21st Century Cures Act, offering clarity about where FDA sees its role in advancing safe and effective #digitalhealth technology: https://t.co/5wstpjreaz

[Ana Mulero, MBA-HCM, CPB, CPC-A 📰 @anitamulero]

"Somryst is the first product submitted to the FDA through the Software Pre-certification Pilot Program, as part of the 2019 Test Plan released by the FDA in January 2019. "

[David Amor @imdavidamor]

@AndreaCoravos @iamthecavalry @jmirpub @AndreaCoravos love this!

[Andy Coravos @AndreaCoravos]

Wrote an op-ed for @WIRED on ethical digital medicine: swapping out pills for AI-driven medical products

(And why we need better social contracts to make this shift safely and effectively) https://t.co/w7Tszu9KQS

[David Amor @imdavidamor]

@howardlook Amazing work guys! Love data dashboards.

[Yuri Maricich MD MBA @ymaricich]

Software to treat disease: digital therapeutics need quality & regulatory https://t.co/SxAW5xCQEJ because patients & clinicians deserve same standards as any other tx @dtx_alliance @Pear_Tx @USPharmacopeia @MikeAtUSP @RonPiervincenzi @imdavidamor #PDT #digitalhealth #biopharma

[Michael Levy @MikeAtUSP]

Thrilled to be part of a panel on #digitaltherapeutics with two leaders in the field @DamJoris and @imdavidamor

[David Amor @imdavidamor]

@chschlaff @_bakulpatel Haha!

[Bakul Patel @_bakulpatel]

[engage] Your input will help shape the next steps that we take to build the program. The FDA also encourages stakeholders to self-organize as groups and provide consolidated feedback.#digital health https://t.co/4Ihu0suPAf #DigitalHealth #FDAPreCert

[David Amor @imdavidamor]

@JohnCarreyrou any chance I can get an advance read of the new book? Have done several talks at conferences on Theranos matter and would love to write a review/ summary. Thanks!

[David Amor @imdavidamor]

Digital health is still health. https://t.co/MLPor14bQ1

[David Amor @imdavidamor]

#FDAPrecert attendees: pause to consider the rarity and magnitude of what we just went through in the public workshop: YOU are impacting digital health policy. #fromstickiestopolicies

[David Amor @imdavidamor]

Level of engagement by FDA during the #FDAPreCert has been exemplary. This is a great model for co-developing a new paradigm in any government-public-private partnership

[David Amor @imdavidamor]

Common theme at #FDAPreCert public workshop: what areas are “hands off” for FDA (i.e why should or shouldn’t FDA care about certain business areas)? Ex: social media metrics

[David Amor @imdavidamor]

Great comment by @howardlook @Tidepool_org about potential delineation of primary indicators (FDA) and secondary (internal) #FDAPreCert

[David Amor @imdavidamor]

Enjoying moderating the breakout sessions on #precert excellence principles https://t.co/le3a1AaTEr

[Bakul Patel @_bakulpatel]

The 10th participants engaging in the #FDAPrecert breakout sessions!

[Bakul Patel @_bakulpatel]

It may be Easy to demonstrate excellence by small companies - .@Tidepool_org and Pear therapeutics - #FDAPrecert #digitalhealth