Security
ClinScreen is designed to provide real-time AI support for pre-screening calls while minimizing operational burden for clinical trial sites. Our default configuration is local-only and session-only, with identifiers optional and OFF by default.ClinScreen is designed to support HIPAA-aligned workflows by minimizing PHI exposure and keeping raw call audio and raw transcripts local in Local-only mode. Your site remains responsible for policies, configuration, and compliance.
Design principles
ClinScreen is built to support workflows that reduce PHI exposure by default. Raw call audio and raw transcripts are designed to remain local on the device.
By default, ClinScreen processes call content for the live session and produces a structured, criteria-mapped summary for the Patient Recruiter/CRC’s workflow.
ClinScreen supports Patient Recruiters/CRCs with prompts and capture. It does not provide medical advice and does not make enrollment decisions.
Default settings
ClinScreen can be customized to your specific site needs and preferences, but these are the defaults we recommend for initial deployments:
ClinScreen is optimized for real-time call support using transcription as the primary input signal. The Patient Recruiter/CRC sees on-screen prompts and capture fields during the call.
By default, ClinScreen is designed to avoid retaining full call transcripts. Instead, the primary output is a criteria-mapped summary and open items list used for next steps.
Direct identifiers (name, DOB, phone, address, etc.) are optional and OFF by default. If enabled, the intent is to store identifiers locally only, based on each site’s preferences and policies.
ClinScreen is built to keep raw call audio and raw transcript text on the MacBook in local-only mode. Cloud services are used for study playbook generation and administration—not for call content.
ClinScreen runs on a MacBook as a call copilot, while the recruiter runs the call using their normal phone workflow. Sites can choose the audio capture setup that fits best: speakerphone (simple) or an optional wired tap kit (cleaner audio).
High-level data flow
A typical “privacy-minimized” ClinScreen session looks like this:
- The Patient Recruiter or CRC runs the call using their normal phone workflow while ClinScreen runs on a MacBook.
- Audio is captured via speakerphone or an optional wired tap kit, transcribed on the MacBook, and used to generate in-session prompts and clarifying questions.
- ClinScreen helps capture criteria-relevant details (e.g., medications, diagnosis history, timing windows, contraception requirements) in structured form.
- At wrap-up, ClinScreen produces a structured, criteria-mapped summary and suggested next steps.
Sites can choose to operate without patient identifiers. When identifiers are excluded, ClinScreen can focus on eligibility-relevant facts without attaching them to a named patient record.
What ClinScreen stores (by default)
- • Criteria-mapped call summary
- • Open items / follow-up questions
- • Study playbook version + session metadata (non-identifying)
- • Cloud copies of raw audio recordings (local-only mode)
- • Cloud copies of raw transcript text (local-only mode)
- • Direct identifiers (optional and OFF by default)
Exact behavior depends on configuration and deployment scope. We will confirm the data handling approach with each site.
Common questions
- BAA: In most cases, a BAA is not required because ClinScreen is designed to avoid transmitting raw transcripts/audio and direct identifiers to cloud services.
- SOC 2 / ISO 27001: ClinScreen is not currently certified, but our security program is aligned with common control expectations and we can share security documentation and respond to vendor questionnaires.
- Retention: Raw audio and raw transcripts remain on the device and are designed for session-only retention unless a site configures otherwise. Cloud retains study playbooks and site administration data; local-only mode keeps call content on the MacBook.
Subprocessors
ClinScreen’s subprocessor list is available on request. If you are piloting ClinScreen, we can provide a current list and explain what each vendor processes.