ARTICLES BY JOHN GIANTSIDIS
Digital Health Apps & SaMD: Incorporating Privacy In Design & Development9/1/2021
Some digital health apps are regulated by the FDA and other regulatory bodies, and some are not. But all software as a medical device (SaMD) and digital health apps have a common expectation: privacy. This article delves into the related regulations and how to go about developing your app or SaMD using the 7 principles of privacy by design.
CMS Takes Aim At Medical Device Cybersecurity – How To Ensure Continuous Medicare/Medicaid Coverage8/4/2021
In its June 2021 report, the U.S. Office of Inspector General declared that Medicare lacks consistent oversight of cybersecurity for networked medical devices in hospitals. The Centers for Medicare & Medicaid Services (CMS) is now considering additional ways to highlight the importance of medical device cybersecurity, in conjunction with the FDA and the Office for Civil Rights.
Are You Ready For The FDA’s “Data Effect” Tsunami? 8 Steps To Prepare5/5/2021
The FDA is moving forward with its Data Modernization Action Plan, the next leg of the Technology Modernization Action Plan. As such, you'll need to prepare yourself for the influx of questions, audits, observations, warning letters, and more. Here's what you can do to position yourself for success.
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.
Germany’s Digital Medical Device Regulations: A Framework For The World To Follow, Part III2/26/2021
Germany's BfArM, or the Federal Institute for Drugs and Medical Devices, released a new guide in August 2020 detailing the requirements for digital health application manufacturers in order to make your DiGAs available to the more than 73 million participants in the German statutory health insurance. In this concluding article in the series, John Giantsidis of CyberActa, Inc. delves into the interoperability, robustness, consumer protection, and patient safety requirements. Other countries will likely soon follow Germany's example.
Germany’s Digital Medical Device Regulations: A Framework For The World To Follow, Part II2/12/2021
Germany's BfArM, or the Federal Institute for Drugs and Medical Devices, released a new guide in August 2020 detailing the requirements for digital health application manufacturers in order to make your DiGAs available to the more than 73 million participants in the German statutory health insurance, and other countries will likely follow in its footsteps. In Part II of this three-part series, John Giantsidis of CyberActa, Inc. examines the data security requirements.
Germany’s Digital Medical Device Regulations: A Framework For The World To Follow, Part I1/29/2021
Germany's BfArM (the Federal Institute for Drugs and Medical Devices) released a new guide in August 2020 detailing the requirements for digital health applications, and other countries will likely follow in its footsteps. John Giantsidis, president of CyberActa, Inc., gives an overview of the situation and will cover the many privacy requirements noted in the new guide in Part 1 of this three-part article series.
Digital Health Apps In Europe — The Road To Reimbursement Goes Through Security11/9/2020
In September, Spain’s National Cryptologic Center issued a road map to minimum security requirements for digital health applications and e-health mobile apps. This article highlights important recommendations from the 11 sections of the publication, serving as a preliminary checklist when preparing for market entry in Germany and/or Spain.
How To Prove (Or Improve) The Trustworthiness Of Your Medical Devices10/7/2020
What objective evidence is necessary to show that your medical device performs as intended for its specific purpose, when needed, with operational resiliency, and without unwanted behaviors or exploitable vulnerabilities? These suggested activities will provide the type of information and objective evidence regulators require to prove the trustworthiness of a device.
Incorporating Privacy By Design & Security By Design Into Medtech Development9/2/2020
Medical device companies need to act now to demonstrate their products' cyber resilience and privacy capabilities, not simply to address the myriad of compliance and data privacy regulations but also to establish patient and caregiver confidence in their products.