DTAC - Digital Technology Assessment Criteria

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 1st July 2021 1.0
Data Flow Diagram B4 10th August 2021 1.0
Clinical Risk Management System C1.1.1 28th July 2021 1.1
Clinical Risk Management Plan C1.1.1 28th July 2021 1.1
GROW 2.0 v.007 Clinical Safety Case Report C1.1.2 1st December 2021 1.0
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 18th November 2021 1.1
Data Processing Agreement PDF | Word C2.3.2 18th November 2021 1.1
Cyber Essentials Certification C3.1 5th May 2021 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 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
Excluded Document: Customer Performance Report D1.13.2 - Reasoning: Product is new with no previous reports available. Will be included 12 months after product release. See additional documents below for GROW 1.5 availability statistics.

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
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