Reflection | Ryan Fitzgerald

Day 1

Our team's meetings with congressional health staffers were very informative and it was nice to get input from people that have experience with issues beyond the scope that our team usually thinks of. One key theme that emerged during our meetings throughout the day was the importance of health in rural populations - a key population that the Pocket Colposcope could benefit in the US. It was often mentioned that while telemedicine is an innovative approach that appeals to many decision makers, the telecommunications infrastructure that is necessary to make telemedicine a reality is often lacking in rural areas of the United States. One interesting point that I learned was that if we had an expert remotely analyze an image taken by a lower-level provider, that expert would have to be an accredited physician in the same state where the image was taken. This issue of state licensure arose several times throughout the day, as did the topic of potential trends towards lessening these regulations to make regional or nationwide telemedicine a reality.

Day 2

The main theme from this day centered around the logistics of reimbursement for the use of the Pocket Colposcope. Whereas we walked in with more logistical concerns about internet access, patient trust, and provider preferences, we left with concerns about how reimbursement would work. Key examples of devices that did not have clear reimbursement mechanisms that caused them to fail were presented to our team, driving this point home. Specifically, the team learned that we would not need our own reimbursement code, but could use the one already used for Colposcopy. On top of this, if a telemedicine approach was instituted, the same Colposcopy code could still be used and the expert reading the image remotely could establish an outside relationship with the clinics to be reimbursed outside of the codes. This day involved many highly productive meetings about how reimbursement coding works in schemes for screening and diagnostic technologies - while making crucial distinctions between the definitions of screening and diagnostic technologies.

Day 3

On our last day of meetings, we established lots of good contacts at the Prevent Cancer Foundation. Here, our patient centered approach was applauded and we had great conversations about future directions for establishing more contacts. Specifically, a conference that they host called the Dialogue for Action could be a great way to establish new relationships important for the Pocket Colposcope. We also had meetings relevant for future iterations of the Pocket Colposcope, including the Callascope and the AI diagnostic technology. I learned that the AI machinery would not be considered a medical device requiring FDA approval if its diagnosis was confirmed by a medical professional, but would be considered a new medical device requiring FDA approval if no medical professional reviewed its diagnosis. This is an important consideration going forward with new technology the center is producing.

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