CyberActa

Establishing security inputs during medical device design and coding phases not only lays the foundation for security against the most common vulnerabilities, but also reduces future costs, as fixing problems at a later stage is more costly. Regardless of the development methodology used, the definition of security controls should start at the design stage, and continue throughout the product lifecycle to ensure that the medical device will continue to have the relevant security measures in case of changes to the initial arrangement due to business or patient needs. #fda #medicaldevice #designcontrol #quality #regulatory #510k #cybersecurity

Our own F. Scott Hall is joining top leaders in the country to chart the course of AI progress, and the critical steps to ensure the health and wellbeing of all Americans. The #NIRMH2024 covers accessibility, governance, policy, law, health equity, and actionable insights from thought-provoking panels and keynote sessions. Learn more and Register ➡ https://lnkd.in/eG9ngYfU. #AI #ArtificialIntelligence #Health #HealthCare #governance #law #regulatorycompliance #policy

I'll be giving a talk at the National Institute of Rural & Minority Health Tri-State Symposium later this month, explaining all the potential potholes on the highway to using AI in an equitable way. Hope to see you there!

📢 Just published - new guidance for medical devices used in combination with medicines 💉 💊 🤝 The document will guide marketing authorisation holders, applicants and notified bodies through some of the changes introduced by the medical devices and in-vitro diagnostics regulations. 🔍 What's inside: ➡ insights on integral drug-device combinations and their lifecycle management ➡ labelling requirements for medical devices co-packaged with medicinal products ➡ information on the consultation procedures for medical devices with ancillary medicinal substances and companion diagnostics Find out more: https://lnkd.in/d6wjy5KN #medicines #MedicalDevices #InVitroDiagnostics #CompanionDiagnostics

Every company, #CEO, #CISO, #CLO and #GC ought to leverage this #SCOTUS ruling to reduce their legal & regulatory risks. CyberActa can take the helm on developing a practical, purpose-led risk governance playbook to help your company stay ahead. Veridat can enhance your #trust with varied stakeholders - investors, customers, employees, governments and regulators. Learn how on https://lnkd.in/eBnGzR2p.

Data products have to designed, built, and maintained with the needs and requirements of its users in mind, just like a traditional product. By treating clinical data as a product, sponsors can stimulate a culture of data sharing and reuse under appropriate circumstances, which breaks down data silos and promotes cross-functional collaboration. This product orientation ensures that data is properly managed and governed, with clear accountability, quality, and access controls. Over time it will improve operational and analytical data quality, reduce data backlogs, lower data storage costs, and reduce data redundancy. These improvements will allow your organization to better leverage their data products and make more effective, data-driven decision-making. #data #transparency #clinical #sponsors #GCP Veridat

Thrilled to announce that Veridat's Robert Huber has been invited to showcase our unimpeachable validation for use in heavily regulated industries, providing end-to-end visibility across networked operations, certifying provenance, supply- value and custody chains, establishing trust in Artificial Intelligence, and security for digital records, information and data. Innovation and trust begins at #LDNBlockchain24. See you in London Blockchain Conference! #trust #supplychain #provenance #ai #artificialintelliegnce #security #records #data #informationassurance #validation

The first Singapore Cybersecurity #Health Report was released today. The survey polled 2,036 small, medium and large organizations on various aspects of #cybersecurity, such as frequency of #cyber #incidents encountered, types of business #impact suffered and adoption levels of cybersecurity measures.