ARTICLES BY JOHN GIANTSIDIS
FDA Releases Guidance On Cybersecurity In Medical Devices5/31/2022
The digital revolution that resulted in the IoT, IoMT, SaMD, and connected devices comes with the possibility of cyberattacks. The FDA's latest efforts to enhance medical device cybersecurity include a new draft guidance (covered in this article) and bipartisan congressional support of the PATCH Act of 2022 (which will be covered in a future article).
FDA Releases Guidance On Digital Health Data Acquisition In Clinical Investigations3/8/2022
Increasingly, digital health technologies are becoming part of the conduct of clinical trials. They cover a broad range of applications, including ingestible and implantable sensors, wearables, electronic signatures on consent forms, and more. This article summarizes the key takeaways of the FDA's new draft guidance, Digital Health Technologies for Remote Data Acquisition in Clinical Investigations. The public comment period ends March 22, 2022.
The Clinical Trial Sponsor’s Roadmap To Avoid EMA (Cyber) Perdition3/1/2022
Clinical trials are one of the sectors most vulnerable to cyberattacks. In the European Medicines Agency (EMA)'s Guideline on computerized systems and electronic data in clinical trials set to come into effect in 2022, the EMA goes beyond the traditional software validation and data integrity expectations. It sets requirements and expectations pertaining to user management and ongoing security measures.
AI/ML-Enabled Medical Devices — 4 Keys To Obtain Global Regulatory Approval3/29/2021
Application of artificial intelligence (AI) and machine learning (ML) in medical devices is making possible AI/ML-driven diagnostics and personalized treatments. By digesting the different jurisdictional AI/ML regulatory frameworks that have been released (draft or enforceable), along with personal experience with the agencies, John Giantsidis, president of CyberActa, Inc., identifies the common denominators crucial to success.