Appointed to Federal Workgroup on FDASIA and HIT safety/innovation

[annaslipp]

Hi All - I haven't been very active on this group, but I wanted to say hello and seek your input, if you're interested, in some of the advocacy work I'm doing on HIT, medical devices and innovation.

I was recently appointed to the ONC's Federal HIT Policy Committee Workgroup on FDASIA. The workgroup members were selected by ONC, FDA and FCC to provide guidance and input on a report to Congress required by FDASIA (the FDA reauthorization act of 2012), specifically advising on ways to create a regulatory framework that both protects patients AND promotes innovation.

I was appointed because of my roles as both a T1D and an HIT entrepreneur.  

All of the meetings are public, so you can follow via Web cast and provide public comments at the end. However, as we prepare to develop the report for ONC, I would certainly be open to/welcome your input.

Here's the announcement from my company's Website, which includes links to other sources of information:

http://www.galileoanalytics.com/galileo-analytics-co-founder-appointed-to-federal-workgroup-on-hit-provisions-of-fdasia/

I look forward to hearing from you! - Anna

[Benjamin West]

Howdy Anna,

It's exciting to hear from you; congratulations on your new post.

I'd be very interested in participating somehow... is there a way to require better technical documentation in the labeling requirements?

-bewest

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[Anthony Di Franco]

Hi Anna,
 I haven't been following developments on this closely but did want to check on where it's been and where it's going. I'm also a type I diabetic and I'm quite underwhelmed by the lack of innovation and lack of effective transition from lab to therapy for promising developments and heavy bias towards treatments relying on disposable and consumable supplies vs. cost and material efficient long-term treatments / cures. My understanding of why this all is this way is that there is a combination of perverse financial incentives and large regulatory overhead that prevents competition.

 I'd hope this committee could recommend reforms similar to recent JOBS act reforms enabling low-regulatory-overhead small-scale financing through crowdfunding, but for medical devices and drugs, to lower barriers to entry and make innovation and competition easier. Please let me know how I can help promote this perspective.

― Anthony

On Mon, May 20, 2013 at 3:09 PM, annaslipp <anna...@gmail.com> wrote:

[Simon Carter]

Hi Anthony,

State of the art in diabetes innovation is http://www.ManageBGL.com.

It integrates data from multiple vendors into a cloud-based system, it predicts BGLs 3 hours ahead, shares data live, and provides live dose coaching and a bolus wizard.

Simon