Sex-based differences in light-based technologies – insurance companies brief

Decision-ready map

• Coverage risk: threshold rules may misclassify differently by sex/life stage

• Contract levers: require model/firmware transparency + sex-stratified evidence

• Protocol levers: symptom-first escalation + confirmatory pathways

• Audit: utilization/outcomes stratified by sex (privacy safeguarded)

• Governance: revalidate after device/algorithm updates; monitor drift

(1) What it is

In RPM and digital pathways, optical thresholds can misclassify differently by sex/life stage (pregnancy, anemia prevalence), affecting safety, utilization, and equity metrics. Validate device transparency and sex-stratified evidence in contracts, ensure symptom-first protocols, and audit outcomes by sex with privacy safeguards.

(2) Who it helps

Medical directors, digital health program leads, contracting teams, and quality/equity leaders reimbursing or contracting optical monitoring tools.

(3) What evidence exists

Sex-dependent PPG features (Dehghanojamahalleh & Kaya 2019); microcirculation differences affecting signal quality (Samils et al. 2023); sex-associated absorption/scattering in DRS (Jonasson et al. 2023; Hung et al. 2015); sex differences in NIRS baseline oxygenated hemoglobin (Asahara & Matsukawa 2023); WHO Hb cutoffs differ by sex/pregnancy (WHO 2024). FDA guidance outlines expectations for sex-specific device evidence relevant to reimbursement durability.

(4) Translation barriers

Commodity reimbursement without model/firmware transparency; pooled outcomes hiding subgroup differences; rigid thresholds without symptom-first escalation; limited mediator data.

(5) Equity/safety checks

Require transparency and sex-stratified evidence; embed mismatch escalation and confirmatory pathways; audit outcomes/utilization by sex with privacy safeguards; monitor drift after updates and hold vendors accountable.

(6) Decision questions

• Do contracts require device model/firmware disclosure + sex-stratified evidence?

• Are thresholds contextualized with symptom-first escalation and clinician review?

• Are pregnancy/anemia pathways handled?

• What dashboards detect inequity early?

• Is reimbursement tied to maintaining subgroup performance after updates?

(7) Practical next steps

1) Update contracts for transparency, sex-stratified validation, and incident reporting.

2) Standardize symptom-first escalation and confirmatory options.

3) Build equity dashboards stratified by sex/life stage where lawful.

4) Establish update governance and revalidation.

5) Tie reimbursement/renewal to maintaining subgroup performance and transparent limits.

(8) References

Dehghanojamahalleh S, Kaya M. Sex-Related Differences in Photoplethysmography Signals Measured From Finger and Toe. IEEE J Transl Eng Health Med. 2019;7:1900607.

https://doi.org/10.1109/JTEHM.2019.2938506

Charlton PH, Pilt K, Kyriacou PA. Establishing best practices in photoplethysmography signal acquisition and processing. Physiol Meas. 2022;43(5):050301.

https://doi.org/10.1088/1361-6579/ac6cc4

Jonasson H, Fredriksson I, Bergstrand S, et al. Absorption and reduced scattering coefficients in epidermis and dermis from a Swedish cohort study. J Biomed Opt. 2023;28(11):115001.

https://doi.org/10.1117/1.JBO.28.11.115001

Samils L, Henricson J, Strömberg T, Fredriksson I, Iredahl F. Workload and sex effects in comprehensive assessment of cutaneous microcirculation. Microvasc Res. 2023;148:104547.

https://doi.org/10.1016/j.mvr.2023.104547

Asahara R, Matsukawa K. Prefrontal oxygenation is quantified with time-resolved NIRS: effect of sex on baseline oxygenation and response during exercise. Am J Physiol Regul Integr Comp Physiol. 2023;325:R31–R44.

https://doi.org/10.1152/ajpregu.00048.2023

Morvová M Jr, Jeczko P, Šikurová L. Gender differences in the fluorescence of human skin in young healthy adults. Skin Res Technol. 2018;24(4):599–605.

https://doi.org/10.1111/srt.12471

Hung C-H, Chou T-C, Hsu C-K, Tseng S-H. Broadband absorption and reduced scattering spectra of in-vivo skin using δ-P1 approximation. Biomed Opt Express. 2015;6(2):443–456.

https://doi.org/10.1364/BOE.6.000443

Staritzbichler R, Hunold P, Estrela-Lopis I, et al. Raman spectroscopy on blood serum samples of patients with end-stage liver disease. PLoS One. 2021;16(9):e0256045.

https://doi.org/10.1371/journal.pone.0256045

WHO. Guideline on haemoglobin cutoffs to define anaemia in individuals and populations. 2024.

https://www.who.int/publications/i/item/9789240088542

NIH Office of Research on Women’s Health. Sex as a Biological Variable (SABV).

https://orwh.od.nih.gov/sex-as-biological-variable

FDA. Evaluation of Sex-Specific Data in Medical Device Clinical Studies (final guidance). March 2025.

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/evaluation-sex-specific-data-medical-device-clinical-studies-guidance-industry-and-food-and-drug