Trust and compliance
Built for the standards future healthcare demands.
HMIT SafetyNet is being developed around the regulatory, information governance and professional standards that shape healthcare software in Ireland and the European Union.
Current status
These frameworks are development targets. Their inclusion does not state or imply that SafetyNet is currently certified, registered, approved or endorsed by any regulator or standards body.
Regulatory framework
Requirements guiding the product roadmap.
Each area below is being considered as HMIT defines, develops, tests and prepares SafetyNet for appropriate clinical use.
Medical Device Regulation
Regulation (EU) 2017/745
SafetyNet processes diagnostic information and helps order the clinical review worklist. Its development is being structured around the requirements that may apply to software as a medical device, including a clear intended purpose, appropriate labelling and instructions for use, clinical evaluation, risk management aligned with ISO 14971 and a quality management approach aligned with ISO 13485.
EU Artificial Intelligence Act
Regulation (EU) 2024/1689
Where AI assisted prioritisation influences the order in which results are presented, the development target includes documented risk management, data quality and traceability, meaningful human oversight and clear information about the role of AI. The reviewing clinician remains responsible for every clinical decision.
Data protection
GDPR and Data Protection Act 2018
The planned approach is based on lawful and limited processing of health information, collecting only what is needed for the agreed purpose, protecting data in transit and at rest, and using hosting within the EU or EEA. Data Protection Impact Assessments, Data Processing Agreements and appropriate retention controls are intended to form part of client onboarding.
HPRA pathway
Health Products Regulatory Authority
HMIT is using HPRA guidance to inform its regulatory roadmap. The intended pathway includes the steps applicable to a medical device manufacturer, such as registration, a named Person Responsible for Regulatory Compliance and vigilance arrangements when required. This is a development pathway and not a claim of current HPRA registration or approval.
Network and information security
NIS2 Directive
The security plan is being shaped around risk management principles reflected in NIS2, including strong authentication, encryption, role based access, security monitoring and a documented response process for incidents. These controls will be assessed against the scope and responsibilities that apply to each deployment.
Health information management
HIQA standards and GP Messaging Standard
SafetyNet is being designed with HIQA principles for safe, accountable, responsive and rights based information management in mind. Its interoperability roadmap includes structured clinical messaging aligned with HL7 version 2.4 where this is required by the relevant GP environment.
Professional accountability
Medical Council guidance and Medical Practitioners Act 2007
The product is intended to support the ordering doctor's responsibility to ensure results are reviewed, followed up and acted on. HMIT does not replace clinical judgement. Where a record or report is attributed to a clinician, the design will support the identifying information required by applicable professional and legal rules.
Primary care interoperability
GPIT and Healthlink ecosystem standards
The interoperability roadmap is being developed around the standards used in Irish general practice, including HL7 version 2.4 messaging, National Individual Health Identifier formatting and validation, and practical data portability and export requirements.
Future health data requirements
Health Information Act 2026 and European Health Data Space
HMIT is tracking the direction of Irish and European health data rules, including patient access, transparency about access to records and future cross border data exchange. These requirements will continue to inform the data model and interoperability roadmap as detailed obligations and implementation timelines apply.
Responsible health innovation
HSE Framework for Health Innovation
HMIT intends to follow a structured approach to evaluation, piloting and responsible adoption, grounded in evidence and engagement with relevant clinical programmes and the wider Irish health innovation community.
Referenced organisations
Standards and bodies informing the work.
These marks are shown only to identify the organisations, regulations and frameworks discussed on this page. They remain the property of their respective owners. Their inclusion does not imply endorsement, approval, certification, accreditation, sponsorship, partnership or affiliation with HMIT.
Copyright and trademarks
Ownership and permitted use.
© 2026 HMIT Health Maintenance IT. All rights reserved.
Copyright
All website content, including text, graphics, logos, icons, images, product screenshots, video, audio, software, page layouts and the overall look and feel, is owned by HMIT or its licensors unless stated otherwise. It is protected by Irish and international copyright, trademark and other intellectual property laws.
You may view, download and print pages for your own personal or internal business use if all copyright and ownership notices remain intact. You may not reproduce, republish, distribute, publicly display, modify, transmit, use commercially or create derivative works from the content without HMIT's prior written permission.
HMIT trademarks
HMIT, HMIT SafetyNet, associated logos, product names and taglines used on this website are HMIT marks, whether registered, pending registration or protected through use, unless otherwise stated. They may not be used, copied, reproduced or displayed, in whole or in part, without prior written permission.
Third party marks and regulatory references
Names, logos, standards and regulatory frameworks belonging to other organisations are the property of their respective owners. They are referenced only to describe requirements relevant to the intended design, development and use of SafetyNet. Where a certification, registration or approval is stated in future, it will apply only to the specific matter and date identified.
No transfer of rights
Nothing on this website transfers or grants any right, title or interest in its content, trademarks or other intellectual property. All rights not expressly granted are reserved by HMIT and its licensors.
Reporting a concern
If you believe content on this website infringes copyright, trademark or another intellectual property right, email Victor@hmitgroup.com with enough detail to identify the material and the right concerned. HMIT will review legitimate concerns.
Governing law
This notice is governed by the laws of Ireland.
Compliance enquiries
Ask about the standards guiding SafetyNet.
Contact HMIT for current documentation, development status or a specific compliance question.