Privacy

Data Protection Impact Assessment (DPIA)

Template pre-filled for research use of OpenBook Clinical Pty Ltd (ABN 38 698 494 656) — OpenBook Clinical. Complete the blank fields for your specific research project.

Template version: 1 July 2025Prepared by: OpenBook Clinical Pty Ltd

Important: This template is provided as a starting point. Your institution's Data Protection Officer (DPO) or privacy officer should review and customise it to reflect your specific research context, institutional requirements, and applicable legislation before submission.

Save as PDF: Print this page (Ctrl+P / Cmd+P) and select “Save as PDF” to generate a document you can submit to your institution.

1. Project Overview

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Complete the fields below for your specific research project. Fields marked with a dashed border require your institution's input.

Project title

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Principal Investigator (name and title)

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Department / School / Faculty

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Institution

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Proposed project dates (start – end)

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Ethics application reference number (if applicable)

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Brief project description (2–4 sentences)

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How will OpenBook Clinical be used in this project?

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2. Nature, Scope, and Context of Processing

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Description of processing activities

Researchers and/or research supervisors will access OpenBook Clinical (openbookclinical.com.au) to search peer-reviewed literature relevant to their clinical or research question. The platform uses AI-assisted synthesis to retrieve and summarise published evidence. No patient data will be entered into the system. The platform does not accept patient identifiers, patient records, or clinical notes.

Categories of data subjects

Researchers, clinicians, and/or students participating in the research project who are registered users of the OpenBook Clinical platform. Patients are not data subjects in this processing activity.

Categories of personal data processed by OpenBook Clinical

Account information (name, email address, professional registration number where provided voluntarily); search query text entered by the researcher; CPD activity logs associated with the account; usage metadata (timestamps, session data).

Data location

Australia (Supabase database, AWS ap-southeast-2, Sydney) for account data and search history. United States (Anthropic API) for AI query processing under a zero-data-retention agreement — query text is not retained.

Data controller

OpenBook Clinical Pty Ltd (ABN 38 698 494 656) is the data controller for account and usage data. For institutional subscriptions with a Data Processing Agreement in place, the subscribing institution may be the controller and OpenBook Clinical the processor.

Any additional processing activities specific to this project

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3. Necessity and Proportionality

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Purpose and legal basis for processing

OpenBook Clinical processes researcher account data to provide access to the clinical evidence retrieval service. The legal basis is the performance of a contract (subscription agreement / terms of service). Research use of the platform does not require separate consent from patients, as no patient data is processed.

Is the processing necessary for the research purpose?

Yes. Clinical evidence retrieval and synthesis is directly necessary for evidence-based research in allied health. OpenBook Clinical provides access to peer-reviewed literature that would otherwise require manual database searching, reducing research burden while maintaining citation integrity.

Proportionality — is the data collected the minimum necessary?

Yes. The platform collects only the information required to provide the service: account credentials, search queries, and CPD logs. No special category data (health information, sensitive personal data) is collected from researchers beyond optional professional registration details. Patient data is explicitly excluded.

Alternatives considered

Alternatives include manual PubMed/CINAHL database searching (more time-intensive, no AI synthesis), institutional library services (available but not always real-time or CDS-integrated), and other commercial CDS tools. OpenBook Clinical is distinguished by its AHPRA-specific focus, Australian regulatory context, and privacy-by-design approach (no patient data accepted).

Any project-specific necessity or proportionality considerations

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4. Risk Assessment

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The following risks have been identified and assessed for standard research use of OpenBook Clinical. Review and supplement with any project-specific risks.

Risk	Likelihood	Severity	Mitigation
Accidental input of patient-identifiable data by a researcher	Low	High	Platform displays a real-time warning when Australian PII patterns are detected in a search query (e.g. Medicare number format, name + DOB combinations). There is no "patient record" field or clinical note field in the user interface. Platform terms prohibit patient data input.
Cross-border data transfer (AI query processing in the US)	Medium	Medium	Anthropic zero-data-retention agreement: query text is processed and immediately discarded; it is not stored on Anthropic systems, not used for training, and not accessible to Anthropic staff. Transfer is secured via TLS 1.3. No patient data is transmitted (see above).
Unauthorised access to researcher credentials	Low	Medium	Multi-factor authentication (MFA) is available to all users and strongly recommended for institutional accounts. Supabase Row-Level Security ensures that a compromised account can only access that account's own data. Unusual authentication events are logged and reviewed.
Data breach affecting researcher account information	Low	Medium	AES-256 encryption at rest; TLS 1.3 in transit; RLS at database layer. NDB scheme notifications within 30 days. Incident response plan is documented. No patient data is held, limiting the clinical impact of any breach.
Researcher reliance on AI output without critical appraisal	Medium	Medium	Platform surfaces citations and evidence grades with every AI response. Limitations notice is displayed prominently. CPD module includes critical appraisal training. AI Governance Framework (published at /governance/ai-framework) documents known limitations and human oversight requirements.

Additional project-specific risks (add rows as needed)

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5. DPO / Privacy Officer Recommendation

Pre-filled (review)

OpenBook Clinical vendor assessment

Based on the vendor's published governance documentation, data classification practices, and security controls, the residual risk associated with standard research use of OpenBook Clinical is assessed as Low. The platform's privacy-by-design approach (no patient data accepted, zero-data-retention AI processing, Australian-hosted database) substantially mitigates the privacy risks typically associated with third-party SaaS tools in clinical research settings.

Recommended conditions for approval

1. Researcher completes the OpenBook Clinical platform orientation prior to use. 2. Researcher agrees not to input patient-identifiable information into any search query or account field, consistent with platform terms of service. 3. All AI-generated outputs are treated as a starting point for evidence review, not as definitive clinical guidance, and are verified against primary sources before use in research outputs. 4. This DPIA is reviewed if the scope of platform use changes materially or if OpenBook Clinical notifies of a sub-processor change or data breach.

Residual risk rating

Low for standard research use as described above.

Institutional DPO / Privacy Officer recommendation (complete for your institution)

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6. Signatures

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Complete the signature blocks below. For printed copies, handwritten signatures are acceptable. For digital submission, electronic signatures or email confirmation from institutional email addresses are accepted by most institutions.

Principal Investigator

Full name

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Signature

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Date

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Research Supervisor (if applicable)

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Date

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DPO / Privacy Officer

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Date

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Head of Department / Ethics Delegate

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Date

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OpenBook Clinical Pty Ltd · ABN 38 698 494 656 · Sydney, NSW, Australia

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