Discover an informative webinar decoding The Food and Drug Administration’s (FDA) 2023 guidelines about the cloud and medical device cybersecurity landscape. Medical device cybersecurity has undergone a game-changing transformation with The FDA’s updated 2023 guidelines, seamlessly integrating both medical device and cloud computing aspects.
In this webinar, specifically designed for research and development (R&D), cyber and development, security and operations (DevSecOps) professionals building and maintaining medical devices, BioT, Sternum, Arnall Golden Gregory and Hogan Lovells LLP will unravel these pivotal updates. The expert panel will dissect the intricacies of the new guidelines, focusing on the dual importance of device security and cloud-based data management.
The webinar will explore key areas such as threat modeling for interconnected devices, cybersecurity risk assessment in cloud environments, interoperability considerations, management of third-party software components and the development of comprehensive Software Bills of Materials (SBOM). Key discussions will include safeguarding patient data in the cloud, ensuring secure data transmission between devices and cloud platforms and navigating the broader evolving regulatory framework for cloud-enabled medical devices.
Join this insightful webinar to be part of a forward-thinking community eager to master the future of medical device cybersecurity in the cloud era.
Flair Bar, Co-Founder & COO, Sternum
With a career spanning over two decades across startups and established enterprises, Flair Bar possesses a wealth of expertise in medical device and healthcare IT.
Prior to joining Sternum’s founding team, Flair held pivotal roles at Zebra Medical Vision, notably serving as VP of R&D and later as VP of Global Operations. In this capacity, she led the clinical, regulatory, customer success and Grants and People operations departments.
Previously, she served as development, product, customer success and sales enablement leader of Interventional Lung Solutions at Medtronic (formerly, superDimension) and drove continuous growth in product sales and revenue.
Flair holds a BSc in Computer Science and Mathematics from the University of Haifa.
Alan Minsk, Partner and Lead of Food & Drug Practice Team, Arnall Golden Gregory LLP
Alan Minsk focuses his practice on advising pharmaceutical, biologic, medical device, cosmetic and food (including dietary supplements) companies on all legal and regulatory matters relating to the US Food and Drug Administration. Alan has been recognized frequently by Who’s Who Legal, Best Lawyers and Chambers USA.
Alan currently serves on the editorial boards for the Food and Drug Law Institute’s (FDLI), Food and Drug Law Journal and Regulatory Affairs Professionals Society’s (RAPS) Regulatory Focus publications.
Daniel Adler, Co-Founder & CEO, BioT
Daniel Adler, the CEO and Co-Founder of BioT Medical, is distinguished by his vast experience in IT, internet, telecommunications and cybersecurity. Leading BioT Medical, Daniel has been instrumental in creating a cloud-based platform designed for medical and pharma companies, focusing on secure and compliant patient-caregiver connectivity.
Prior to BioT, he made significant contributions at Valens Semiconductor as the head of the automotive business unit and managed various segments including healthcare. His tenure at Digital Clues and NICE Systems showcases his deep involvement in cybersecurity, where he played a pivotal role in strategic partnerships and business development.
John Miller, VP Americas, BioT
John is BioT’s Vice President Americas, leading our go-to-market efforts with clients and partners.
John brings to the role extensive experience helping life science clients create platforms and solutions from a diverse set of technologies: app dev, analytics, data and cloud.
Most recently, John led US client management for the medical device and semiconductor industries at Mendix (acquired by Siemens). Clients leveraged Lowcode Application Development to build and deploy custom, cloud-based applications for Digital Thread, Supply Chain, Regulatory and Connected Customers use cases.
Prior, he ran go-to-market in the eastern and central US at an Israel-based startup Elastifile (acquired by Google). The first US clients leveraged Elastifile and GCP to run high-performance genomics and drug discovery workloads on the cloud.
In addition, John has worked in both the US and UK in global sales and product management roles for EMC and NCR and in management at a privately-held marketing firm.
John holds a Bachelor of Arts in Economics from Columbia University, and lives in Charlotte, NC.
Alex Smith, Director of Regulatory Science, Hogan Lovells LLP
As a former process and software engineer at GlaxoSmithKline and Human Genome Sciences, Alex’s primary practice involves assisting companies with medical device and pharmaceutical submissions that involve software such as AI/ML submissions and 21 CFR Part 11 concerns. During his time at Hogan Lovells, Alex has provided software architecture and lifecycle advice on substantial variety of devices such as AI radiological imaging, 3D adaptive manufacturing, infusion pumps, and individualized vaccines involving AI.
Who Should Attend?
This webinar will appeal to those with the following titles:
- Developers of device and cloud software
- DevSecOps professionals
- Product Managers, QA/RA professionals, IT Experts
What You Will Learn
Attendees will gain insights into:
- Aligning system designs with The FDA’s 2023 cybersecurity guidelines, focusing on secure architecture, cloud integration and effective SBOMs management
- How to continuously monitor devices and cloud systems, and their software code, to meet the FDA guidelines
- Critical considerations like differentiating between safety and security risk management, the importance of integrated security processes, threat modeling and comprehensive cybersecurity testing.
BioT provides a cloud platform for building medical devices that serve remote users from clinical study to full-scale commercialization. Unique for its self-service, regulated modules, BioT enables developers to launch and update medical solutions quickly while alleviating regulatory and cybersecurity risks. The platform supports over 100,000 FDA-approved devices across various clinical domains for over 30 MedTech customers.