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Preparing a medical device to meet the EU MDR requirements can be difficult in some cases. It can be challenging when cybersecurity testing doesn’t cover its complete attack surface. The vulnerabilities may not be known until the APIs, cloud services, mobile apps, wireless interfaces, firmware, and hardware are tested. EU MDR Penetration testing makes it […]

The National Health Authority (NHA) runs the Ayushman Bharat Digital Mission (ABDM) to help India’s healthcare providers share patient records securely with patient consent. If your software works as a Health Information Provider (HIP), Health Information User (HIU), Health Locker, or Consent Manager, you cannot get live production keys without proving your system is secure. […]

Key Takeaways   Good enterprise AI governance rests on four things working together: someone clearly accountable for each model, controls that scale with risk, security testing that actually pokes at the system, and monitoring that doesn’t stop once the model ships. A risk-based framework doesn’t treat every AI system the same – high-risk systems get tighter […]

Every year, millions of Americans use the Affordable Care Act (ACA) Marketplace to enrol in health insurance. Large amounts of sensitive data are being exchanged behind these exchanges, such as Personally Identifiable Information (PII), Protected Health Information (PHI), and Federal Tax Information (FTI). The Centers for Medicare & Medicaid Services (CMS) has adopted the Minimum […]

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 […]

Choosing one penetration testing provider can be harder when almost every vendor claims that they are offering expert testing and strong security. You should look for a CREST-accredited penetration testing company that can offer a complete penetration testing service. This shows the importance of choosing top CREST-accredited penetration testing companies for 2026 buyers. CREST accreditation […]

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, […]