THE CHALLENGE
Adherence on the specialty therapy was below modelled expectations, and patient support calls were concentrated on a handful of avoidable questions. The brand team wanted a digital companion — reminders, education, side-effect tracking, easy routes to a specialty pharmacy or nurse line — without turning the app into a regulatory liability.
Internal and external barriers stacked up. The MLR (medical, legal, regulatory) committee was strict, and rightfully so. Patients living with the condition had specific accessibility needs. The commercial team wanted useful engagement metrics that didn't pretend a medical app was a marketing app. Everyone wanted it done yesterday.
THE APPROACH
- Patient and clinician co-design. Journey mapping with patients living with the condition plus interviews with treating clinicians surfaced the moments the app had to earn its place. Accessibility tested with screen-reader users and low-dexterity participants from day one.
- Regulatory-first architecture. HIPAA and PIPEDA baselines; data minimization by default; PHI handling documented in a DPIA; content review integrated into the CMS via an MLR workflow rather than bolted on.
- Native build on Swift and Kotlin. Performance and accessibility were decisive. Dynamic Type, VoiceOver and TalkBack, high-contrast theme, and motor-accessibility patterns tested per release.
- Store submission handled. App Store Review and Play Console submissions managed by the delivery team, including the medical-app review nuances that trip up first-time submitters.
- Measurement plan agreed up front. Enrollment, sustained use, and self-reported adherence treated as primary; engagement micro-metrics treated as diagnostic, not celebratory.
THE RESULTS
- ** enrollments** in the first quarter post-launch.
- 12-point adherence lift on the follow-up study (self-report, matched cohorts with enrolment status as proxy).
- 29% 30-day retention among enrolled patients.
- WCAG 2.2 AA conformance verified by third-party audit pre-launch; no post-launch accessibility complaints escalated.
- MLR cycle time reduced vs. legacy email-and-PDF workflow; MLR approval logged inside the CMS for audit.
- 4.8★ App Store / 4.8★ Play Store ratings after 90 days.
CLIENT QUOTE
"The day MLR signed off on a live content change inside the CMS, we knew we had the right team." — Senior leader, anonymized, Anonymized leadership
SERVICES INVOLVED
RELATED CASE STUDIES
METHODOLOGY & MEASUREMENT
Enrolment measured from Day 0; retention via standard cohort methodology; adherence lift derived from a pre-specified follow-up study with defined inclusion criteria. Accessibility audit by a third party. DPIA, threat model, and MLR SOP available under NDA for prospective clients and auditors.
SOURCES & FURTHER READING
- HHS — HIPAA Privacy Rule (US health-information privacy baseline)
- Office of the Privacy Commissioner of Canada — PIPEDA (Canadian private-sector privacy law)
- W3C — WCAG 2.2 specification (accessibility conformance standard)
- FDA — Policy for Device Software Functions and Mobile Medical Applications (US regulatory guidance for medical apps)
- PhRMA — Code on Interactions with Health Care Professionals (industry code referenced in MLR practice)