Analysis and commentary
Standards guidance from our consultants, and press commentary from partners quoted across the BBC, FT, Bloomberg, The Times and The Telegraph.
Dr Alexander Graham · 24 July 2026NHS Digital Health Compliance Guide
Developing a successful digital health product is only part of the journey.
ReadDr Alexander Graham · 24 July 2026ISO 13485 is the first step for Medical Device Software Compliance
ISO 13485:2016 is the internationally recognised quality management system (QMS) standard for medical device manufacturers, providing the governance framework needed to develop, manufacture, and maintain compliant medica
ReadDr Alexander Graham · 13 July 2026ALARP in Digital Health: Understanding Risk Reduction for DCB0129, ISO 14971 and EU MDR
ALARP stands for As Low As Reasonably Practicable.
ReadDr Alexander Graham · 10 July 2026Risk Log vs Hazard Log: What's the Difference?
Many health technology companies already maintain a risk log or risk register to manage project and business risks. Then they begin preparing for NHS deployment under DCB0129 and discover they also need a Hazard Log.
ReadDr Alexander Graham · 10 July 2026What is AMLAS? A Guide to Machine Learning Assurance for Medical Device Manufacturers
AMLAS (Assurance of Machine Learning for use in Autonomous Systems) is an open assurance methodology that helps organisations develop structured safety arguments demonstrating that machine learning (ML) components are su
ReadDr Alexander Graham · 10 July 2026Clinical Risk Management in Digital Health
Clinical risk management is the structured process of identifying, assessing, controlling and monitoring risks of patient harm arising from health IT systems.
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Dr Saif Abed, MD · 2 July 2026Cyber Essentials for NHS Suppliers
Cyber Essentials has become the baseline cybersecurity certification that many NHS suppliers are expected to achieve as part of procurement, supplier assurance, and wider cybersecurity due diligence activities.
ReadDr Alexander Graham · 2 July 2026ISO Standards for NHS Healthcare
ISO standards play an increasingly important role in NHS procurement, assurance, and risk management.
ReadDr Alexander Graham · 2 July 2026What is ISO 42001? A Guide for AI Medical Device Manufacturers
Artificial intelligence (AI) is transforming healthcare, from diagnostic imaging to clinical decision support to remote patient monitoring.
ReadDr Saif Abed, MD · 2 July 2026The DSPT Version Guide: Standards-Based to CAF-Aligned
The Data Security and Protection Toolkit (DSPT) is NHS England's annual online self-assessment that enables organisations to measure and demonstrate their compliance with the National Data Guardian's data security standa
ReadDr Saif Abed, MD · 29 June 2026ISO 27001 Annex A Controls Explained
ISO 27001 Annex A (sometimes referred to as ISO 27001 Appendix A) is the control reference section of ISO/IEC 27001:2022.
ReadDr Saif Abed, MD · 24 June 2026NHS SOC and STRIDE Threat Modelling
Healthcare organisations face cyber risks at every stage of the technology lifecycle.
ReadDr Saif Abed, MD · 13 May 2025NIS2 & Executive Liability – A Critical Priority for Medical Device Manufacturers
The NIS2 Directive, in force across the EU from October 2024, introduces one of the most significant regulatory shifts in cybersecurity governance in over a decade.
ReadDr Saif Abed, MD · 28 August 2024Digital Technology Assessment Criteria (DTAC)
It is essential that any digital health technologies undergo proper assessment. This ensures they meet quality standards and are safe for use, especially within the NHS or social care settings.
ReadRussian hackers stole UK government official's logins in major national security breach
This is exactly the type of hack that's the first step for launching catastrophic ransomware attacks…
ReadRussian hackers steal government logins
ReadHackers breach Foreign Office systems with stolen logins
ReadMore than 5,000 NHS Scotland data breaches since 2023
The NHS, unfortunately, lacks transparency with the public when it comes to the scale of data breaches.
ReadGovernment considers use of break clause in Palantir NHS contract
Called for NHS procurement reform around DCB0129, DSPT and MHRA requirements.
ReadCyber security expert calls for public inquiry into Synnovis attack
Delivered at the HETT 2025 conference, London.
ReadHackers steal passwords from UK's NHS with sneaky malware tool
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Financial Times · 25 June 2025NHS cyber attack led to patient death
Told the FT he believed more patients had died in recent years than publicly reported.
ReadSynnovis cyber attack caused two cases of severe patient harm
…likely just the tip of the iceberg.
ReadFinancial Times · 24 October 2024NHS staff use WhatsApp “constantly” to share private patient data
From a data privacy and security perspective it is entirely problematic…
ReadUK Ambulance Services targeted by Kremlin-protected Russian hackers
ReadVoice-Care achieves mandatory DCB0129 compliance
a leading authority on all aspects of cybersecurity in safety critical sectors
ReadFinancial Times · 21 July 2024NHS hack prompts tougher UK cyber security rules for private providers
ReadHacked UK trove includes data on newborns, cancer patients
The NHS has some of the best patient safety and cybersecurity standards in the world. They are just immensely poorly enforced.
ReadHealth to be on cyber-security's front line in 2021
Dr Saif Abed has long warned that such an attack could kill a patient.
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