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Over the years, I have worked with various financial institutions, fintech companies, and crypto businesses across Europe, and one similarity that I have observed is that organisations often know they must meet regulatory requirements but are unsure which framework governs licensing, which covers cybersecurity, and how they both align.  MiCA (Regulation EU 2023/1114) is a […]

Creating a safe medical device is not only about the performance of the device. Modern manufacturers have to comply with changing cybersecurity regulations. You need to safeguard connected devices, ensure the safety of the software supply chain, and identify cybersecurity threats during the product life cycle. Adopting appropriate medical device cybersecurity frameworks has now become […]

The Mandatory Shift Toward Ayushman Bharat Digital Mission By 2026, ABDM integration is not a differentiator you put on a pitch deck. It is a regulatory prerequisite for any HealthTech platform, EMR or HMIS product, or diagnostic network operating in India. Hospitals empanelled under PM-JAY and CGHS are required to run ABDM-compatible software, which means […]

Partnering with a reliable security vendor is the easiest way to make sure that your security audits stand up to the tough regulations. If the procurement department requires proof of your organization’s cyber readiness, engineering processes might not allow production downtime. Selecting non-accredited vendors or relying solely on automated security scanners can lead to failed […]

The U.S. The Food and Drug Administration (FDA) enforces strict cybersecurity requirements under Section 524B of the Federal Food, Drug, and Cosmetic (FD&C) Act. All manufacturers filing a 510(k) for a cyber device are required to submit a complete, comprehensive machine-readable Software Bill of Materials (SBOM).  Section 524B(b)(3) of the FD&C Act makes it statutory, […]

Introduction: The Growing Weight of Data Privacy in Qatar Your systems are encrypted, access is locked down, and the last pen test looked solid. Then the National Cyber Security Agency asks for the Data Protection Impact Assessment on that new payment platform you launched last quarter, and you realise there is no document to hand […]

A lab may produce the right result, yet still face a serious problem if the system carrying that result cannot be trusted. Today, diagnostic information often moves through connected instruments, software, cloud services, and APIs before it reaches the people who use it. A weakness anywhere along that route can expose patient data or disrupt access […]

Getting ready for a HITRUST assessment becomes challenging once you consider that penetration testing is just a normal security procedure. Even once the testing process is completed, issues arise due to deficiencies within the HITRUST penetration testing requirements, scope, remediation, or retesting. Knowing what the requirements are for such tests is crucial for any entity […]

Twenty European jurisdictions have now formally adopted the TIBER EU framework, according to the ECB’s own published list, spanning everywhere from Germany and France to Iceland and Malta. That’s not a framework sitting quietly in a policy drawer somewhere in Frankfurt. It’s become the default language European regulators use when they talk about testing whether […]