Cybersecurity for prescription digital therapeutics and DTx apps.
Prescription digital therapeutics are mobile- and web-first SaMD with patient-identifiable data and clinical claims. We deliver mobile and API penetration testing, SBOMs, and threat models built for DTx submission packages.
Prescription DTx products live mostly on patient phones and in the cloud - which makes mobile, identity, API authorization, and back-end PHI handling the dominant attack surfaces. The device boundary is the app + the cloud, not the phone.
DTx ships at SaaS cadence (weekly or faster). Cyber regression has to be CI/CD-integrated, not a once-a-year pen test, and PCCPs are increasingly the path to keep release velocity inside the FDA framework.
Typical clinical uses
Key data flows & integrations
Root/jailbreak detection, secure storage, and TLS pinning are basic expectations for prescription-class mobile SaMD.
Object-level authorization gaps (BOLA) are the #1 finding in DTx backends.
Analytics and ad SDKs in DTx apps frequently leak PHI - SBOM and SDK review are essential.
Prescription DTx products live mostly on patient phones and in the cloud - which makes mobile, identity, and back-end APIs the dominant attack surfaces.
Threat models must assume the OS is hostile, the app is reverse-engineered, and the user can be socially engineered.
DTx ships weekly or faster - cyber regression testing has to be CI/CD-integrated, not a once-a-year pen test.
DTx sits under FDA, HIPAA, and increasingly state health-privacy laws - documentation must reconcile all three.
Payer/EHR integrations (FHIR, SMART) bring new auth flows and trust boundaries that need explicit modeling.
What FDA scrutinizes
Reviewers expect a model that assumes the OS is hostile, the app is reverse-engineered, and the user can be socially engineered.
Broken object-level authorization is the #1 finding on DTx pen tests; FDA and hospital security teams both expect explicit testing.
PCCP + CI/CD security gates are how you keep weekly releases compliant without re-submitting.
No - HIPAA covers privacy and breach response, not the FDA premarket cybersecurity content. You need both.
OWASP MASVS L2 by default for prescription DTx, with MSTG-driven test cases. We tune verification level to your risk profile.
Each SDK is enumerated in the SBOM, its data flows are mapped, and any PHI exposure is flagged. We typically recommend stripping ad/attribution SDKs from the prescription build.
Yes - the clinician-facing portal, EHR integrations, and any caregiver views are scoped together with the patient app so authorization and tenancy are tested coherently.
A typical premarket cyber package (threat model + SBOM + mobile pen test + API pen test + report) runs 3–5 weeks depending on backend complexity.
We help you write privacy and security disclosures consistent with both Apple/Google policies and your FDA submission so they don't conflict.
Mobile + cloud threat modeling, SBOM, and pen testing for prescription DTx - without enterprise overhead.
"Blue Goat Cyber's depth of expertise was impressive. We had no in-house cybersecurity experience, and their team guided us through every step of the FDA process. The penetration testing and SBOM testing were thorough and gave us complete confidence."
Cybersecurity for prescription digital therapeutics and DTx apps.
