ARTICLES BY JOHN GIANTSIDIS

• FDA Seeks Input On AI Adoption In Drug Development And Manufacture

  6/13/2023

  The FDA released two discussion papers for consideration: Using Artificial Intelligence and Machine Learning in the Development of Drug and Biological Products and Artificial Intelligence in Drug Manufacturing. The papers identify current and potential areas for AI adoption.

• New EU Directive Marks Cybersecurity Regulatory Paradigm Shift For Bio/Pharma & Medical Devices

  2/15/2023

  The EU's new Directive 2022/2555 on the Security of Network and Information Systems (“NIS2”) mandates cybersecurity risk management measures and reporting requirements for all segments of our industry, including labs; CROs and CDMOs; and manufacturers of APIs, bio/pharmaceuticals, and medical devices.

• CMS Takes Aim At Medical Device Cybersecurity – How To Ensure Continuous Medicare/Medicaid Coverage

  8/4/2021

  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 Prepare

  5/5/2021

  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.

• Germany’s Digital Medical Device Regulations: A Framework For The World To Follow, Part III

  2/26/2021

  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 II

  2/12/2021

  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 I

  1/29/2021

  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.

• How To Prove (Or Improve) The Trustworthiness Of Your Medical Devices

  10/7/2020

  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 Development

  9/2/2020

  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.