Compliant consent for every patient interaction
Certinal replaces paper consent, manual intake, and uncontrolled forms with one platform built for healthcare. Every consent digitally captured, legally signed, version-controlled, and filed to your EHR
- HIPAA
- CMS-0053-F
- 21 CFR Part 11
- DPDP
- SOC 2 Type II
- PDPA
Trusted by healthcare organizations
Compliance is the starting line
01
HIPAA
Patient data encrypted at rest and in transit. Full audit trail on every consent event. BAA available.
02
CMS-0053-F
Electronic standards for claims attachments and signatures by May 26, 2028. Certinal meets these standards today.
03
21 CFR Part 11
FDA-grade electronic signatures for clinical trial consent, IRB documentation, and medical device records.
04
SOC 2 Type II
Independently audited controls over how Certinal stores, processes, and transmits protected health information.
05
DPDP Act 2023
Purpose-based consent collection, documented audit trails, and data subject rights management for Indian healthcare organizations.
06
PDPA
Compliant consent capture, preference management, and cross-border data handling for healthcare organizations in APAC.
The consent problem isn't One Problem. It’s Three.
Hospitals manage consent across disconnected systems, uncontrolled forms, and undocumented data collection. Each gap is a compliance exposure and they compound.
Certinal fills the gap between all three
Consent workflows, document signatures, rights tracking, template governance, evidence packs, and compliance reporting — one system of record for healthcare’s regulatory reality.
01
Consent is still on paper
Surgical consent, treatment authorization, clinical trials — captured on paper, filed by hand, version-uncontrolled. One misfiled form delays an OR, triggers an audit finding, or opens a malpractice claim.
- 15-minute consent delay = $700+ in wasted OR time
- No visibility into which consents are complete until pre-op
- Outdated form versions circulate without anyone noticing
02
Patient data is collected without
governance
Patients hand over demographics, insurance, and medical history on a clipboard. No documented consent purpose. No audit chain. No record of what they agreed to.
- HIPAA, DPDP, and PDPA require proof of lawful collection
- No preference management or patient rights portal
- Cross-border operations face overlapping mandates with no unified system
03
There's no single source of truth
Consent lives in one system. Signatures in another. Intake in a third. Credentialing in a fourth. No consolidated audit trail. Every gap is a compliance risk.
- No unified record connecting consent, signature, and document version
- Claims documentation still moves by fax — CMS-0053-F changes that by May 2028
- Audit readiness depends on manual reconciliation across systems
Consent — captured, signed, governed, and proven
Surgical consent, treatment authorization, clinical trials — captured, signed, and filed to the patient chart before anyone has to ask where it is. Every event audit-trailed. Every document court-admissible.
01
Informed consent workflows
Surgical, clinical trial, telehealth, and general treatment consent. Launches inside your EHR. Procedure-specific forms auto-matched to the scheduled encounter. Consent status visible to the care team in real time.
02
Digital patient intake
Pre-visit registration from any device. Demographics pre-populate from the EHR. Every data point tied to a documented consent purpose.
03
Digital forms library
Version-controlled repository for clinical, administrative, and departmental forms. Outdated versions auto-retired. Joint Commission and DNV ready.
04
Electronic signatures
Legally binding, tamper-evident, time-stamped. Signer identity verified at capture. Full chain-of-custody from signature to storage. HIPAA, 21 CFR Part 11, and CMS-0053-F compliant.
Frequently Asked Questions
What types of consent does Certinal handle?
Surgical consent, procedure-specific informed consent, clinical trial consent, general treatment authorization, and data processing consent. Documents are version-controlled, linked to specific procedures, and auto-filed to the patient record.
Does Certinal integrate with our EHR?
Directly with Epic, Oracle Cerner, MEDITECH, and OpenEMR. Consent forms launch inside your EHR and signed documents write back to the patient chart. Other systems connect via HL7 and FHIR APIs.
How does Certinal handle HIPAA compliance?
Data encrypted at rest (AES-256) and in transit (TLS 1.2+). Signed BAA with every healthcare customer. Annual SOC 2 Type II audits. Full audit trail on every consent and signature event.
Can patients complete consent and registration before they arrive?
Yes. Patients receive a secure link via SMS or email. Demographics can pre-populate from the EHR. Completed consent and intake forms are in the patient chart before the appointment.
Does Certinal support DPDP Act compliance?
Yes. Purpose-based consent collection, documented consent trails, and patient preference management. Every data point tied to a processing purpose. Patients can view, modify, or withdraw consent. Full audit chain on every interaction.
Does Certinal meet 21 CFR Part 11 requirements?
Yes. Signer authentication, tamper-evident seals, and complete audit trails. Covers clinical trial consent, IRB documentation, and FDA-regulated electronic records.
What is CMS-0053-F and does Certinal comply?
A federal rule finalized March 2026 adopting electronic standards for claims attachments and signatures. Compliance required by May 26, 2028. Certinal’s electronic signature capabilities meet these standards.
How long does implementation take?
7 business days for a single facility. Multi-facility rollouts within 30–60 days. Dedicated implementation manager on every deployment.
Every patient interaction starts with consent.
Every consent needs proof.
Certinal gives you both. One platform. See it in 15 minutes.
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