N241-D02 TITLE: DIRECT TO PHASE II: Safeguarding Warfighter Medical Data: Secure Encrypted Transmission of Physiologic Monitoring (PhysMon) Data

OUSD (R&E) CRITICAL TECHNOLOGY AREA(S): Sustainment

OBJECTIVE: Design and manufacture a more secure method of transmitting physiology endpoint data from wearable aircrew physiologic monitoring (PhysMon) devices.

DESCRIPTION: In 2010, the number of hazard reports from military aircrews related to physiological episodes (PEs) increased compared to previous years and have continued to rise sharply each year since 2012. An attributable cause to the increase in reported PE can be an increased awareness regarding the phenomenon; however, a single root cause has not been identified. PEs, as experienced by flight crews, have consisted of multiple symptoms, including cognitive impairment, numbness, tingling, lightheadedness, behavioral changes, and fatigue. These reports have been connected to several Class A mishaps, leading to a growing awareness across all aircraft activities on the recognition of inflight human symptomology. While reported PEs peaked in FY15–16, in recent years there has been a marked decline; however, they still occur, and between FY18 to FY23 there have been reports of 934 PEs, some resulting in significant medical complications. Most of the reported PEs have been in the F/A-18 community including legacy (F/A-18C) and super hornets (-E, -F, and -G); however, PEs are also reported in the T-46, T-6, and F-35 communities.

Since 2010, the U.S. Navy (USN) and U.S. Air Force (USAF) have been working diligently to determine the cause (or causes) of PEs. While several vulnerabilities have been identified and corrected, reports of PEs still persist (934 between FY18-23) and have shown to be difficult to diagnose with causal factors remaining elusive. Mitigating the risk of PE has proven to be complex and not rooted in one single cause. Additionally, it is critically important to note that this is not a U.S. Navy-exclusive problem. It is a joint issue affecting aviators and aircrew across the Department of Defense (DoD) component services, including the USAF, U.S. Army (USA), and our International partners. The USN stood up two root cause and corrective action (RCCA) teams for both the F/A-18 and the T-45 with the mission to investigate PE for both platforms. Among the 564 recommendations between the two teams, the RCCA recommended that the USN take actions to research aircraft components and physiological monitors for aircrew members; maintain, upgrade, and test aircraft components; as well as train aircrew members on gear fit and potential PE symptoms to reduce PEs.

In recent years, the DoD has invested a significant amount of funding and resources into the investigation of unexplained PEs within the flight environment. As part of this effort, devices to monitor the physiological state of aircrew have been proposed, prototyped, developed, and tested in a variety of environments, including in-flight. These devices range from forehead patches to measure near-infrared spectroscopy (NIRS, functional or cerebral), compression garments with integrated heart rate and respiratory sensors, eye trackers within helmets or simulated cockpits, pulse oximetry (SpO2), instrumented orinasal masks, and electroencephalography to measure neural activity during environmental exposures. Aircrew physiological monitoring during flight operations to identify signs and symptoms associated with PE end states could help better identify causal factors, improve treatments and outcomes, and return aircrew to operational duty sooner. Combined with the fact that PEs still occur, the requirement for aircrew PhysMon remains a top capability gap and a top safety issue across the DoD and component services.

The commercial medical instrument industry is well established in the manufacture of devices designed to monitor various physiological endpoints. The military leverages these commercially available devices as starting points to adapt, optimize, and ruggedize for operation in a dynamic aircraft environment and hostile military environments. The common feature between those commercial medical devices and those specially augmented for the military is their means of connecting to IT devices to transmit their data.

Bluetooth is a short-range wireless technology used for exchanging data between fixed and mobile devices over short distances. Medical monitoring devices universally employ this technology standard to transmit physiologic data. Additional benefits include reduced device bulk and no wires. Both are unwelcome snag hazards to worn flight gear and equipment/hardware inside the cabin/cockpit. Snag hazards are not only detrimental to crew resource management (CRM) for normal and combat operations, but can constitute a substantial impediment in the event aircrew are required to ditch from the aircraft. As a result, the PhysMon devices currently evaluated by the USN and USAF for use in operational flight environments also use Bluetooth.

Unfortunately, Bluetooth is not secure and is vulnerable to a variety of hacking and tracking methods. While its short range provides some measure of protection, the technology has continued to improve over time, and in the case of active U.S. military operations and Private Health Information (PHI), this is insufficient. Bluesnarfing (information theft), bluejacking (spam, phishing, malware), bluebugging (backdoor access to spy), bluesmacking (denial of service), and car whispering (eavesdropping on communications) make continued use of Bluetooth in deployed, wearable PhysMon devices an unacceptable risk.

The Navy requires a more secure method for transmitting data from wearable PhysMon devices and replace the universally used Bluetooth. While military versions will likely require additional security measures subject to the area of operations (AO) or area of responsibility (AOR), commercial development of a more secure method of transmission for wearable PhysMon devices would be positively received and relevant. Methods can include, but are not limited to, magnetic secure transmission. Important considerations are Size, Weight, and Power (SWaP) requirements, wireless capability, no interference with worn gear, and battery endurance.

While PhysMon devices are mature technologies and available commercially in various forms, operation in conjunction with aircrew flight/safety gear or within the unique confines of an aircraft cabin (hypobaric pressure, oxygen-enriched, temperature) was not a primary factor in their design. The USN and DoD have been developing a number of devices in response to PE that are optimized for military environments, but like their commercially available counterparts, these military-specific devices use Bluetooth for data transfer. The increased computerization of today’s military and evolving cyber threats necessitate a more secure way for transmitting physiological data.

Advanced, innovative solutions for secure, encrypted transmission of data from wearable PhysMon devices are sought. Design can include, but is not limited to, Magnetic Secure Transmission (MST) technology, commercial encrypted wireless links (CEWL) or miniature encrypted wireless links (MEWL) and/or Ultra Wide Band (UWB) Radio Frequency Identification (RFID) and Wireless Intercom System (WICS).

The candidate technology will demonstrate the ability to securely transmit medical endpoint data from an existing wearable PhysMon device. The technology developed will eventually be required to be adapted to a flight environment on military aircraft with special emphasis on naval environments featuring moisture and salt. Highly desirable criteria include minimal size profile, low power requirements, long battery life, minimum weight and bulk, wireless, and no interference with flight/safety gear. In order to have a common reviewing process for all potential applicants, it is requested that all submitting performers, at a minimum, employ heartrate as the physiologic endpoint of the wearable monitoring device. 1. Threshold: The method of recording heartrate should be—at a minimum—similar to fitness trackers, Photoplethysmography (PPG). 2. Objective: Full wave 60Hz electrocardiogram (ECG).

Other important considerations include: 1. The device should provide secure transmission to both storage and real-time display of monitored physiologic endpoint data. 2. There are many existing commercial and military-optimized wearable PhysMon devices currently available. The ability to convert these existing devices for secure transmission of data is a desirable objective. 3. For existing wearable monitors, designs may not allow easy access into device housing for reasonable modification of machinery. An attachable dongle to these existing devices overriding the stock Bluetooth in favor of the secure method is a desirable objective. 4. This technology should be able to transmit data across a distance of at least 240 m (This is the range of Bluetooth 5.0. Bluetooth 4.0 is 60 m).

Note: NAVAIR will provide Phase I performers with the appropriate guidance required for human research protocols so they have the information to use while preparing their Phase II Initial Proposal. Institutional Review Board (IRB) determination as well as processing, submission, and review of all paperwork required for human subject use can be a lengthy process. As such, no human research will be allowed until Phase II and work will not be authorized until approval has been obtained, typically as an option to be exercised during Phase II.

PHASE I: PHASE I: For a Direct to Phase II topic, the Government expects that the small business would have accomplished the following in a Phase I-type effort. It must have developed a concept for a workable prototype or design to address at a minimum the basic requirements of the stated objective.

The below actions would be required in order to successfully satisfy the requirements of Phase I: the candidate technology will demonstrate the ability to securely transmit medical endpoint data from an existing wearable PhysMon device. The technology developed will eventually be required to be adapted to a flight environment on military aircraft with special emphasis on naval environments featuring moisture and salt. Highly desirable criteria include minimal size profile, low power requirements, long battery life, minimum weight and bulk, wireless, and not interfere with flight/safety gear. In order to have a common reviewing process for all potential applicants, it is requested that all submitting performers—at a minimum—employ heartrate as the physiologic endpoint of the wearable monitoring device.

1. Threshold: The method of recording heartrate should be—at a minimum—similar to fitness trackers, Photoplethysmography (PPG).

2. Objective: Full wave 60Hz electrocardiogram (ECG).

FEASIBILITY DOCUMENTATION: Offerors interested in participating in Direct to Phase II must include in their response to this topic Phase I feasibility documentation that substantiates the scientific and technical merit and Phase I feasibility described in Phase I above has been met (i.e., the small business must have performed Phase I-type research and development related to the topic NOT solely based on work performed under prior or ongoing federally funded SBIR/STTR work) and describe the potential commercialization applications. The documentation provided must validate that the proposer has completed development of technology as stated in Phase I above. Documentation should include all relevant information including, but not limited to: technical reports, test data, prototype designs/models, and performance goals/results. Work submitted within the feasibility documentation must have been substantially performed by the offeror and/or the principal investigator (PI). Read and follow all of the DON SBIR 24.1 Direct to Phase II Broad Agency Announcement (BAA) Instructions. Phase I proposals will NOT be accepted for this topic.

Note: Please refer to the statement included in the Description above regarding human research protocol for Phase II.

PHASE II: Develop a working prototype that securely transmits medical endpoint data from an existing wearable PhysMon device and is suitable for use in the flight environment and during operations. Ensure that the prototype meets the requirements listed below. Begin to validate the use of the prototype with human participants. Through this testing and evaluation process make iterative refinements to the prototype. Required Phase II deliverables will include a working prototype, and a report about the overall project progress.

It is important to note that the goal of this SBIR topic is to develop a more secure method to transmit physiologic monitoring data from wearables rather than developing a new wearable device for monitoring. As such, this SBIR topic is open to applications proposing a new secure wearable monitor or modification of existing wearable monitor incorporating secure transmission methods of physiologic endpoint data. Additional endpoints such as respiration rate, pulse oximetry, and so forth are welcome. However, all performers must propose a device that measures heartrate.

Other important considerations include:

1. The device should provide secure transmission to both storage and real-time display of monitored physiologic endpoint data.

2. There are many existing commercial and military-optimized wearable PhysMon devices currently available. The ability to convert existing devices for secure transmission of data (desirable objective).

3. For existing wearable monitors, designs may not allow easy access into device housing for reasonable modification of machinery. An attachable dongle to these existing devices overriding the stock Bluetooth in favor of the secure method (desirable objective).

4. This technology should be able to transmit data across a distance of at least 240 m (the range of Bluetooth 5.0. Bluetooth 4.0 is 60 m).

Note: Please refer to the statement included in the Description above regarding human research protocol for Phase II.

PHASE III DUAL USE APPLICATIONS: Using the results and progress made during Phase II, complete any remaining work necessary to have the proposed solution meet the performance parameters described in this topic., Demonstrate its performance in a military-relevant environment and ensure production readiness.

Ensure that the final design solution is easily adaptable for occupations requiring physiologic monitoring during operations, including long-haul trucking. Availability to the private sector shall also be considered as the wearable medical device and fitness-tracker industries continue to grow and more of the public purchases for personal use.

The global wearable medical device and fitness-tracker market size is valued at $26.8 billion in 2022. Companies including Apple, Samsung, Google, Fitbit, Oura, and Amazon continue to develop smaller, wearable devices that incorporate physiologic monitoring. Additionally, these devices also include GPS tracking, as well as integration and linking of cell phone/cloud account (AppleID, Google account, etc.) features such as ApplePay.

Commercial applications for such technology would be healthcare providers employing wearable PhysMon devices for their patients, long-haul trucking or commercial airline industry for monitoring alert-status of drivers and pilots, and, finally, private citizens using wearables for recreational use such as fitness trackers.

Secure wireless interlinking of commercial wearables, particularly those with the capability of contactless payment, would be highly received by the public.

REFERENCES:

Commander U.S. Pacific Fleet. (2017, June 12). Comprehensive review of the T-45 and F/A-18 physiological episodes. Department of Defense. https://news.usni.org/2017/06/15/document-the-navys-physiological-episodes-comprehensive-review

Wiegman, Kristi. (2023). 2024 NAVAIR SBIR/STTR Focus Areas. Department of the Navy.

Shaw, D. M., & Harrell, J. W. (2023). Integrating physiological monitoring systems in military aviation: a brief narrative review of its importance, opportunities, and risks. Ergonomics. https://pubmed.ncbi.nlm.nih.gov/36946542/

Hernández-Álvarez, L., Bullón Pérez, J. J., Batista, F. K., & Queiruga-Dios, A. (2022). Security threats and cryptographic protocols for medical wearables. Mathematics, 10(6), 886. https://doi.org/10.3390/math10060886

KEYWORDS: Physiologic monitoring; PhysMon; Encryption; Bluetooth; Aircrew; Electrocardiogram; Photoplethysmography

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