BAA Call 006 ARMD0001.pdf

BAA 692M15-20-R-00004

White Paper Call 006

Federal Aviation Administration Pilot Medical Certification Tele-Examination

February 1, 2022

This Call (006) for white papers is being issued in accordance with FAA Broad Agency Announcement (BAA) 692M15-20-R-00004, which was posted on FAACO.com on December 05, 2019 and last updated on sam.gov on January 26, 2022. Respondents must refer to the document entitled 692M15-20-R-00004 Rev R9, Amendment 008 (January 26, 2022) in conjunction with this Call to prepare and submit their white paper. All instructions set forth in the 692M15- 20-R-00004 Rev R9, Amendment 008 solicitation document apply to the Call. This Call provides supplemental information and specific criteria to the Government requirements. Information included herein applies to this Call only.

The FAA has an immediate requirement in support of research Topic Number:

ARMD0001 Federal Aviation Administration Pilot Medical Certification Tele- Examination. Safety as described below. White papers submitted under this call are due by close of business on March 15, 2022. White papers received after that date will be considered under the BAA Topic related to this Call, however, selection of the technologies may already be complete for the specifics of this Call.

Topic Number: AMRD0001;

Federal Aviation Administration Pilot Medical Certification Tele-Examination

Technical POC: Anthony P. Tvaryanas; Anthony.P.Tvaryanas@faa.gov Alternate POC: Stacey Zinke; Stacey.Zinke@faa.gov Copy: 9-ACT-AAQ-600-BAA@faa.gov

Background:

The Federal Aviation Administration (FAA) requires pilots to receive a medical certification exam with a designated FAA Aviation Medical Examiner (AME). Medical certification is needed to protect pilots and others, as the physical demands of flight can be imposing. Medical certification is time limited, the duration of which is risk-based given consideration of type of aerospace operations and pilot age and health status. During the public health emergency caused by the SARS-CoV-2 virus, pilots were unable to schedule medical examinations with AMEs, necessitating the FAA to extend arbitrarily the duration of medical certification for several months. This situation was undesirable because it removed one of the safeguards for ensuring human reliability in aerospace operations.

A future public health emergency may prevent the accomplishment of the in-person AME medical certification exam visit for a sustained period, thereby potentially invalidating certification risk estimates made at the last medical certification exam. Assuming it is necessary to continue some degree of aviation operations, the FAA needs a contingency solution to accomplish the maximum number of elements comprising the medical certification exam as practical using telemedicine. This research problem aligns with DOT’s innovation goal by conducting research on technology to promote transportation safety and efficiency. It is also within scope of the aeromedical research program objectives described in the FAA’s 2021 Annual Modal Research Plan.

Purpose:

The purpose of this Topic is to leverage the general wave of innovation in telemedicine driven by the current public health emergency for application in support of aviation safety. The research question is, “What minimum set of existing telemedicine technologies and associated procedures provide the necessary data to address the maximum number of physical exam items on FAA Form 8500-8?1 The resulting solution is broadly scoped and can include, but is not limited to, video conferencing and data transmission capabilities; medical devices and measurement apps or technologies with data transmission and or storage capability; standardized procedures for conducting individual exam elements; integration of elemental procedures into an overall standardized exam workflow; and any required examinee training. It should be integrated into an equipment package that is mailed to the pilot (and AME if necessary) and jointly used by the AME and pilot through an internet connection. The solution should comply with general rules for the practice of telemedicine.

Since the AME medical certification exam shares key elements with a general purpose physical exam, the resulting solution should be marketable to primary care providers such as family practice and internal medicine clinics. Additionally, this same problem exists across transportation modes where there is a requirement for vehicle operators to maintain medical certification. As aviation requires the most rigorous medical certification exam among the modes, the solution will be able to address the requirements of other modes (e.g., Commercial Driver Medical Exam, etc.).

https://www.faa.gov/about/office_org/headquarters_offices/avs/offices/aam/ame/guide/

Requirements:

The FAA would like proposals to address the following:

Expected Phase I Outcomes At the end of the 6-month Phase I period, the expected outcome is a final report documenting each of the FAA Form 8500-8 physical exam data elements and the associated telemedicine assessment/measurement solution, the associated level of evidence supporting its validity, and its cost. To the extent possible within available time and funding, a walk- /talk-through presentation and/or demonstration of a telemedicine exam is desired.

Expected Phase II Outcomes and Deliverables The Phase II period should be a natural extension of the Phase I period. The expected outcome is the prototype, integrated telemedicine equipment package in the configuration mailed to a pilot and AME (if necessary) and jointly used by a pilot and AME. Testing data

1 https://www.aviationmedicine.com/wp-content/uploads/2014/03/FAA-Form-8500-8-GG-Edition-APPLICATION- FOR-AIRMAN-MEDICAL-CERTIFICATE.pdf should include a usability assessment by a sample of representative patients and physicians.

Additionally, a summary design document and commercialization plan should be provided.

Set-Aside Determination:

This topic is set-aside exclusively for small businesses (NAICS Code 541714) under the Small Business Innovation Research Program.

Period of Performance/Rough Order of Magnitude:

Efforts lasting up to 30 months will be considered. Continued efforts at the completion of each milestone or deliverable are at the discretion of the Government, based on performance and results.

These efforts are anticipated to be funded annually, subject to availability of funds. ROM for this research is expected not to exceed $100,000.00 for Phase I and $300,000.00-$500,000.00 for Phase II, for any awards made under this announcement.