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DTAC is the NHSX assessment criteria for health and social care that gives staff, patients and citizens the confidence that the digital health tools they use meet clinical safety, data protection, technical security, interoperability, usability and accessibility standards, defined by NHSX. The DTAC is designed to be used by healthcare organisations to assess suppliers at the point of procurement or as part of a due diligence process to make sure they meet minimum baseline standards.
Further information about the NHSX DTAC is available here
This DTAC applies to GROW 2.0 - A digital health technology product provided by Perinatal Institute.
| Document | DTAC Code | Date Uploaded | Version |
| DTAC – GROW 2.0 | N/A | 30th January 2024 | 1.1 |
| Data Flow Diagram | B4 | 10th August 2021 | 1.0 |
| Clinical Risk Management System | C1.1.1 | 5th April 2023 | 1.3 |
| Clinical Risk Management Plan | C1.1.1 | 30th Jan 2023 | 1.2 |
| GROW 2.0 v.007 Clinical Safety Case Report | C1.1.2 | 1st December 2021 | 1.0 |
| GROW 2.0 – Clinical Safety Summary Statement | C1.1.2 | 14th February 2024 | 1.2 |
| GROW 2.0 MIS API Release Clinical Safety Case Report | C1.1.2 | 14th February 2024 | 1.2 |
| Clinical Authority to Release (CATR) | C1.1.2 | 18th November 2021 | 1.0 |
| Hazard Log | C1.1.2 | 29th July 2021 | 1.1 |
| UK Medical Device Regulations 2002 Declaration of Conformity Registered with MRHA as Class I Medical Device Reference No. 5298 & 2021063001207326 |
C1.3.2 | 30th June 2021 | 1.0 |
| Clinical Risk Management documentation Conformity certificate for third party suppliers (ISO27001) |
C1.4.1 | 5th May 2021 | 1.0 |
| Information Commissioner's registration completed Self-assessment | C2.1 & C2.2.1 | 10th May 2021 | 1.0 |
| Data Protection Impact Assessment (DPIA) | C2.3.2 | 4th July 2022 | 1.2 |
| Data Processing Agreement PDF | Word | C2.3.2 | 4th July 2022 | 1.3 |
| Cyber Essentials Certification 2023 | C3.1 | 6th September 2023 | 1.0 |
| Internal Penetration Test Summary Report - 2023 | C3.2 | 8th August 2023 | 3.0 |
| Internal Penetration Test Summary Report - 2022 | C3.2 | 6th May 2022 | 1.0 |
| Internal Penetration Test Summary Report - GROW 2.0 First Release Internal Penetration Test Summary Report - GROW 2.0 Pilot |
C3.2 | 5th May 2021 | 1.0 |
| External Penetration Test – GROW 2.0 – 2023 | C3.2 | 16th October 2023 | 1.0 |
| External Penetration Audit - GROW 2.0 - 6 Page Executive Summary | C3.2 | 21st June 2021 | 1.0 |
| User Journey | B4 & D1.2.1 | 11th August 2021 | 1.0 |
| User Acceptance Testing | D1.3.1 | 30th May 2021 | 1.0 |
| Excluded Documents | |||
| Excluded Document: Wearable Device Compliance C4.4.1 - Reasoning: Product is not a wearable device | |||
Additional Documents
| Document | Date Uploaded | Version/Year |
| ISO 27001 Accreditation: Certificate | 5th May 2021 | 1.0 |
| GROW 1.5 Uptime Availability: 2020/21 | 3rd May 2021 | 1.0 |
| GROW 2.0 Uptime Availability: 2023/24 | 11th April 2024 | 1.0 |
| GROW 2.0 Backup Site Uptime Availability: 2023/24 | 11th April 2024 | 1.0 |
| Clinical Reference 1: (Customized growth charts: rationale, validation and clinical benefits) | 6th May 2021 | 2018 |
| Clinical Reference 2: (Fetal growth surveillance – Current guidelines, practices and challenges) | 7th May 2021 | 2018 |
| Clinical Research | 2022 | N/A |