Put one Consent API in front of OneTrust and enforce it as an Omni Gateway policy on every channel and agent call into Life Sciences Cloud — email, visits, patient programs, and Agentforce — with EU and multi-country rules, purpose-level checks, and an audit trail of every allow and deny.
Tags: life-sciences, life-sciences-cloud, pharma, medtech, consent, onetrust, privacy, omni-gateway, agentforce, api-led
Consent API for Life Sciences Cloud: OneTrust Enforced at the Gateway
Objective: Make consent a check that every outbound action passes through rather than a field each channel reads its own way. OneTrust stays the system of record for preferences and lawful basis; MuleSoft exposes it as one Consent API and enforces it as a gateway policy, so email, visits, patient support, and agents all get the same answer for the same person, purpose, and country.
What's Getting Built
- OneTrust (System API) — reads and writes data subjects, purposes, and preferences in OneTrust ·
GET /datasubjects/{id}/purposes, POST /consentreceipts
- Consent (Process API) — answers allow or deny for a person, purpose, channel, and country, applying country rules on top of OneTrust ·
POST /consent/check, GET /consent/{personId}, POST /consent/capture
- Consent enforcement policy (Omni Gateway policy) — calls the Consent API before outbound channel and agent requests and blocks a deny ·
POLICY consent-check
- Consent change events (Anypoint MQ) — publishes withdrawals and updates so LSC and downstream systems stop acting within minutes ·
PUBLISH consent.changed
Value chain phase
Phase 06 — Commercial & Patient Services. Marketing to healthcare providers (HCPs) and patient support program delivery.
- Scope of this plan: Consent and preference enforcement for every channel and agent that reaches HCPs and patients from Life Sciences Cloud.
- Data in this phase: CRM (Veeva / Salesforce Life Sciences Cloud), prescription data, and logs.
- Receives from: Phase 05 — Supply Chain & Logistics.
- Hands off to: Nothing downstream — this phase closes the loop back to Research & Discovery with real-world evidence.
Prerequisites
- Anypoint Platform org with API Manager, Runtime Manager, and a non-production deployment target.
- Salesforce Life Sciences Cloud org with a connected app and an integration user scoped to the objects this plan writes.
- Secrets Manager or secure properties configured for every system credential.
- Named owner for each source system — integration stalls on access, not on code.
- OneTrust Consent and Preference Management with API credentials and a purpose catalog agreed with legal.
- Omni Gateway (Flex Gateway) in front of the channel and agent APIs that send outbound contact.
- Country rules from privacy counsel — opt-in versus opt-out, double opt-in markets, and retention periods.
- A shared person identifier — the golden HCP ID or patient ID — so consent and the contact refer to the same individual.
Choose your path
- Enforce at the gateway — Choose when channels and agents already call APIs — the policy blocks a deny before the request reaches the sender.
- Check in the flow — Choose for batch sends and file-based channels that never pass a gateway — the flow calls the Consent API per record before release.
Architecture
1. Model consent as purpose, channel, and country
- Ask one question: may this person be contacted for this purpose on this channel in this country right now.
- Keep the purpose catalog in OneTrust and refer to it by ID; never hard-code purpose names in flows.
- Treat no record as deny in opt-in markets and as allow only where counsel has confirmed opt-out applies.
2. Enforce on every call
- Apply the consent policy on every outbound API, including agent tools — an agent action is a contact like any other.
- Return a reason code with a deny so the channel can show the rep or agent why, without exposing the underlying record.
- Cache allow decisions for minutes, never deny decisions, and drop the cache on a consent.changed event.
3. EU and multi-country rules
- Resolve the country from the person's jurisdiction, not the sender's location.
- Apply double opt-in where the market requires it before the first marketing contact.
- Keep withdrawal immediate in every market — a withdrawal reaches LSC as an event, not on the next batch.
4. Capture and round-trip
- Write consent captured in LSC, on a portal, or by an agent back to OneTrust as a receipt with source and timestamp.
- Publish every change to Anypoint MQ so LSC, the data cloud, and marketing tools update together.
5. Security, privacy, and compliance
- Validate the integration under GAMP 5 — requirements, design, IQ/OQ/PQ evidence, and a traceability matrix retained for inspection.
- Meet 21 CFR Part 11 and EU Annex 11 for electronic records and signatures on every GxP-relevant flow.
- Preserve ALCOA+ data integrity — attributable, legible, contemporaneous, original, and accurate — with audit trails no operator can edit.
- Encrypt regulated data in transit and at rest, and keep production payload visibility to validated support roles only.
- Treat a mapping change on a GxP flow as a controlled change under change management, never as a hotfix.
- Meet GDPR, HIPAA where patient data is involved, and local marketing law for each market in scope.
- Log every allow and deny with person, purpose, channel, and decision, retained for the period counsel sets.
For pre-built API specifications, implementation templates, and reference architecture, see the MuleSoft Accelerator for Life Sciences on Anypoint Exchange.
Sample payload — Consent check
{
"personId": "HCP-000482913",
"purpose": "promotional-email",
"channel": "email",
"country": "FR",
"requestedBy": { "type": "agent", "id": "lsc-field-assistant" },
"decision": "deny",
"reason": "no-opt-in-recorded"
}
Testing and validation
- Withdraw consent in OneTrust and confirm the next email and agent action for that person are blocked within minutes.
- Check a person with no record in an opt-in market and confirm the answer is deny.
- Call an agent tool that sends outreach and confirm the gateway policy runs before it.
- Capture consent in LSC and confirm a receipt appears in OneTrust with the source recorded.
Phased rollout
Phase 1 — Connect
- Build the OneTrust System API and the Consent Process API for one market.
- Agree the purpose catalog and country rule table with legal.
Phase 2 — Map and validate
- Turn on the gateway policy for email and visits in that market and measure decision latency.
- Add consent.changed events and confirm LSC updates on withdrawal.
Phase 3 — Production
- Extend to agent tools and patient programs, then roll market by market.
- Hand decision logs and deny-rate monitoring to the privacy office.
Success metrics
- Every outbound channel and agent tool behind the consent policy.
- Time from withdrawal in OneTrust to block in every channel, measured in minutes.
- Contact attempts without a consent decision, at zero.
Troubleshooting
- A withdrawn HCP still receives email — Likely cause: the batch email tool bypasses the gateway. Fix: Move the send behind the Consent API check per record, or route it through the gateway.
- Deny rate spikes in one market — Likely cause: country resolved from the sender, not the person. Fix: Resolve jurisdiction from the person's record and re-run the affected decisions.
Deliverable: A Consent API over OneTrust, an Omni Gateway policy enforcing it on every channel and agent call into Life Sciences Cloud, country rules in configuration, and a decision log for audit.