Consent Language
Clear description of procedures, risks, and benefits plus explicit authorization for use and sharing of protected health information where required by HIPAA.
A clear, signed pilot agreement establishes consent, limits institutional liability, and documents data handling and reporting. Proper execution supports regulatory compliance and preserves evidence of participant authorization.
The Healthcare Pilot Program is used by clinical operations, research teams, and vendor partners to document pilot terms and participant consent.
Use a signed pilot document to create an auditable trail for compliance, contracting, and post-pilot evaluation.
| Field | Recommended Setting |
|---|---|
| Signer Authentication | Email + SMS code or KBA where required |
| BAA Requirement | Enable BAA with third-party vendors |
| Audit Trail | Capture IP, timestamp, and actions |
| Document Retention | Retain per HIPAA and institutional rules |
Assess integrations, storage, and authentication capabilities before running a healthcare pilot.
Complete before IRB submission; timing varies
Allow 2–8 weeks depending on institution
Defined in protocol; often 30–180 days
Specified study duration in protocol
Follow HIPAA and institutional retention rules
Finalize objectives, endpoints, and data fields.
Obtain IRB or ethics committee authorization.
Begin consenting and onboarding participants.
Complete data collection and preserve final records.
Clear description of procedures, risks, and benefits plus explicit authorization for use and sharing of protected health information where required by HIPAA.
Define data elements collected, permitted recipients, de-identification steps, retention, and permissible secondary uses of data.
Specify encryption, access controls, breach reporting, and whether a Business Associate Agreement (BAA) is required.
List duties for the sponsor, healthcare provider, data steward, and any technology vendor during the pilot period.
Define success criteria, measurement intervals, reporting cadence, and ownership of analytical outputs.
Set procedures for early termination, data return or destruction, and post-pilot obligations.
A hospital tested a workflow change for admission triage
A university piloted a remote monitoring device study
| Criteria | Simple e-sign | PKI digital | Remote notarization |
|---|---|---|---|
| Legal Validity | |||
| Authentication Strength | low | high | high |
| Audit Trail | |||
| Use Case | low-risk consents | regulated submissions | notarized acknowledgements |
| signNow | DocuSign | Adobe Sign | PandaDoc | HelloSign | |
|---|---|---|---|---|---|
| Starting Price | $8/user/mo | $15/user/mo | $14/user/mo | $19/user/mo | $15/user/mo |
| Free Trial | 7-day free trial | Varies by plan | Varies by plan | Varies by plan | Varies by plan |
| Bulk Send | Yes | Yes | Yes | Yes | No |
| Audit Trail | Yes | Yes | Yes | Yes | Yes |
| HIPAA Compliant | Yes | Yes | Yes | No | No |
| Envelope Cap | No envelope cap | 100 envelopes/user/year | Varies by plan | Varies by plan | Varies by plan |