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Healthcare
Software suppliers, medical device manufacturers and healthcare providers face significant cybersecurity risks and technology compliance requirements to ensure patient safety.
WHich standards matter in healthcare?
The most prominent standards the technology suppliers and healthcare providers must consider include:
- DCB0129 (UK only)
- DCB0160 (UK only)
- Data Security and Protection Toolkit (DSPT) (UK Only)
- Network Information Security Directive 1 & 2 (UK & Europe)
- EU Medical Device Regulation (MDR)
- ISO27001 Information Security Management Systems
- ISO22301 Business Continuity Management Systems
- ISO14002 Artificial Intelligence Management Systems
Our expertise across all these areas will ensure that your organisation is implementing effective risk management practices.
Preserving Patient Safety
Risk management of technology in healthcare focuses on the preservation of patient safety in the face of malfunction, misuse or cyber-attacks. Our experts work with organisations to run risk assessments, develop documented policies, conduct audits and review incidents to demonstrate successful compliance with best practice. Key points that all technology suppliers and healthcare providers need to consider include:
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Have you appointed a Clinical Safety Officer (CSO) to be responsible for the safety of technology systems?
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Do you maintain an accurate risk register?
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Do you have documented and rehearsed business continuity plans for critical technology systems?
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Have you analysed the risks stemming from new technology products such as AI?
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Is your organisation complying with data ethics and privacy requirements?
DO I need to comply with all standards?
Depending on which jurisdictions you operate in then certain standards will be mandatory. It is strongly recommended that all organisations prepare technology risk management documentation based on ISO standards as these are recognised globally as markers of compliance that align with the majority of national and regional regulations.
Here at The AbedGraham Group, we can help you to navigate risk management standards and requirements, so get in touch to find out more.
How do We Ensure
Compliance?
Ensuring your organisation is fully compliant with best practice standards and requirements involves a structured core methodology we have implemented and implemented over a decade with technology companies and government agencies:
1. Baseline AUDIT
Step 1 involves a baseline audit of your existing policies, procedures and documentation through a series of workshops, document reviews and detailed checklists. Completion of this stage leads to the production of a gap-analysis report outlining your existing compliance status and a project plan to address shortfalls.
2. Risk analysis & documentation
Step 2 involves an extensive review of all technology related product and organisational risks including quantification, prioritisation and the development of risk controls in line with the relevant standard your organisation is aligning to. These will be documented in a risk management document portfolio which will include details descriptions of new policies and procedures being implemented to mitigate identified risks. The document portfolio can be shared with customers, partners and regulators to demonstrate compliance.
3. Re-audit
After 3-9 months our consultants will return to audit your organisation to confirm that the policies and procedures from Step 2 have been implemented and that the gaps in compliance maturity from the baseline audit have been addressed effectively. At this stage, it is also possible to request for our team to conduct an audit which will officially certify your organisation against certain standards (subject to ISO auditor availability).
FAQs
Is DCB0129 mandatory?
DCB0129 is mandatory if your product is considered applicable, as part of the Health and Social Care Act 2012. You must show evidence of a suitable risk assessment and appoint a Clinical Safety Officer to manage DCB0129 compliance on an ongoing basis. If you are unsure as to whether your product is applicable, then contact us for a free consultation.
What is clinical risk in the NHS?
Clinical risk management in the NHS is centred around the deployment of two standards: DCB0129 (applying to vendors) and DCB0160 (applying to healthcare organisations). Vendors must ensure they have covered all parts of the standard to ensure compliance that they can show to healthcare organisations, regulators and partners.
What is digital clinical safety?
Digital clinical safety is about ensuring that technologies deployed in the NHS are safe to use, but also that those technologies then help to improve patient safety. The Digital Clinical Safety Strategy published in 2021 outlines the nationwide strategy and the stakeholders involved in maintaining this.
Ready To Speak to One of the team?
If you need help with your DCB0129 compliance, or any other healthcare legislation, partnering with The AbedGraham Group will ensure your applications run smoothly and that you are able to operate in the healthcare sector.