Intended Use Statement

This statement describes the intended use and regulatory classification of CorePathology. It is published alongside our Terms of Use and applies to all versions of the software, marketing materials, and supporting documentation provided by Infonote Datasystems Ltd.

1. Intended Use

2. Regulatory Classification

CorePathology is not a medical device as defined under the UK Medical Devices Regulations 2002 (as amended) and is not an in vitro diagnostic medical device as defined under Regulation (EU) 2017/746 (IVDR) or its UK equivalent.

Infonote Datasystems Ltd has determined this classification on the basis that CorePathology:

• Does not generate, derive, calculate or interpret clinical results
• Does not apply diagnostic algorithms or rules to patient data
• Does not modify, transform or augment clinical content entered by laboratory staff
• Does not independently produce information that informs diagnosis, prognosis, treatment decisions or patient management
• Acts solely as an operational record and workflow tool under the direct control and responsibility of qualified laboratory staff

3. What CorePathology Does

CorePathology supports laboratories by providing:

• Case and specimen tracking: recording the physical journey of samples through the laboratory
• Workflow recording: capturing which staff member performed which task at which time
• Document compilation: assembling case information entered by qualified staff into a single document for the laboratory's use
• Terminology entry: allowing staff to record standardised codes (such as SNOMED-CT) that they select based on their own clinical judgement
• Quality management: supporting document control, non-conformance management, training records, reagent tracking and audit logs
• Operational reporting: generating workload, turnaround time, financial and audit reports from operational data
• Integration: connecting to external systems (scanners, instruments, hospital information systems) as a conduit for information exchange

4. What CorePathology Does Not Do

CorePathology does not:

• Analyse, interpret or assess specimens, slides, images or samples
• Suggest, propose or recommend diagnoses, SNOMED codes, or clinical findings
• Validate the clinical accuracy or appropriateness of content entered by laboratory staff
• Replace the professional judgement of pathologists, biomedical scientists or other qualified healthcare professionals
• Act as the source of truth for clinical decisions; the source of truth is the authorised case record maintained by the laboratory and its qualified staff
• Perform calculations on clinical data that influence diagnosis or treatment

5. User Responsibilities

Customers using CorePathology are responsible for:

• Ensuring that all clinical interpretation, diagnosis, reporting and authorisation is carried out by qualified medical professionals
• Maintaining their own quality management systems, accreditations and compliance obligations
• Verifying that any content produced by, or compiled through, CorePathology is accurate and complete before use in patient care
• Operating the software within the scope of its intended use as described in this statement

6. Changes to This Statement

We may update this statement from time to time to reflect changes in legislation, guidance or the software itself. The "Last updated" date at the top of this page indicates when it was last revised. Material changes will be communicated to existing customers in accordance with our Terms of Use.

7. Contact

Questions about this statement should be directed to:

Infonote Datasystems Ltd
United Kingdom
Email: legal@corepathology.com
Phone: 01858 467746