New FDA Guidance on Medical Device Cybersecurity Management: Addressing Insecurity of Medical Things
Medical device cybersecurity management, coupled with stricter FDA regulations and scrutiny, is undergoing a wide extension in scope and scale due to the increasing demands for affordable, more convenient, and sophisticated healthcare services. Global technological advances have led to the incorporation of micro-processors and chips into almost any device imaginable, including medical devices such as a heart pacemaker.
The internet and network connectivity have provided the right platform to build intelligent and real time healthcare services. However, along with new serious cybersecurity issues and threats is a growing need for effective cybersecurity requirements across the full product lifecycle of medical devices, applications, and software.
Developing dependable medical devices can be a long and tedious process. Innovations in medical devices also come with liability risks considering the serious harm that software defects may cause to users and patients. In this light, a panel of industry thought leaders and diverse professionals in cybersecurity risk analysis system organized by The Knowledge Group will help the audience understand the latest trends and critical issues in 2017 and will go beyond the basics of Medical Device Cybersecurity Management. Speakers will provide tools and best practices in establishing and conducting robust risk assessments for medical devices and in overseeing and monitoring cybersecurity programs. They will also offer practical tips to minimize damage and liability in the event of a security breach.
The panel will also discuss, but not limited to:
- FDA Cyber Security Guidance – An Overview
- Medical Device Software: FDA Device Guidance
- Cybersecurity Measures in Product Design
- Cybersecurity Requirements and System for Medical Devices
- Standard Cybersecurity Frameworks
- Cybersecurity Risks and Consequences
- Medical Device Design and Cyber Security Risk Mitigation and Management
- Legal Risks of Medical Device Breaches
- Legislation Trends and Best Practices
Paul S. Rosenblatt, Attorney
Butler Snow LLP
- FDA Cyber Security Guidance – An Overview
- Examples of Cyber Security Risks with Medical Devices
- Conducting a Risk Analysis and Building in Pre-Market Controls
Carolyn Purwin Ryan, Partner
Cipriani & Werner, PC
- Post Market Management of cybersecurity in medical devices
- Tips to Establishing Efficient, Robust Cybersecurity Measures
- Legal Trends and FDA Communications About Cybersecurity Vulnerabilities
Who Should Attend:
- Healthtech Law Attorneys
- Healthcare Service Providers
- Medical Device Industries Professionals
- Medical Device Manufacturing Companies
- Cybersecurity Officers
- Software Architects
- Privacy Law Attorneys
- Chief Compliance Officers
- Risk and Compliance Managers
- Privacy and Data Security Lawyers and Consultants
- Technology Attorneys
Paul Rosenblatt is a litigator at Butler Snow. As a member of the Pharmaceutical, Medical Device and Healthcare Group, Paul defends pharmaceutical and medical device manufacturers in mass tort and individual cases pending in various state and federal venues throughout the country. Paul represents Ethicon, Inc. and Johnson & Johnson in federal MDL and state court litigation involving medical devices. As part of the national expert team, Mr. Rosenblatt has retained and developed experts, prepared and defended experts for depositions and trials, as well as deposed plaintiffs’ general and specific causation experts. Mr. Rosenblatt has also deposed treating physicians, plaintiffs, and fact witnesses. He has also assisted lead counsel with preparing and defending the depositions of several company witnesses and 30(b)(6) witnesses. Additionally, Paul has been a part of the national trial teams assisting the lead trial attorneys in nine mass tort trials in federal and state courts. Paul graduated from Mississippi College School of Law with his JD/MBA in 2012. He is a 2016 graduate of the IADC Trial Academy and was selected by Mississippi Business Journal as one of the Top 50 Leaders in the Law in 2015. Paul is also a member of DRI, MDLA, Capital Area Bar Association, and Jackson Young Lawyers.
Paul Rosenblatt is a litigator at Butler Snow. As a member of the Pharmaceutical, Medical Device and Healthcare Group, Paul …
Mrs. Ryan is a partner at the firm of Cipriani & Werner. Mrs. Ryan’s areas of concentration include life science litigation, products liability, cyber security and medical malpractice litigation. She serves as counsel in several state and federal mass tort litigations representing manufacturers and distributors of pharmaceuticals, medical publishers, clinical trial companies, cardiac devices, prosthetics, generic drugs, hip and knee implants, plasma and blood related products and treatments, defibrillators, cosmetic skin lasers, vision devices, surgical mesh and various surgical devices. Mrs. Ryan also focuses her practice on the litigation of professional liability matters where she represents health care systems, hospitals, physicians, nurses, dentists and other health care providers in complex cases involving catastrophic injuries. She serves as national counsel for domestic and international companies.
Mrs. Ryan is a member of the Information Privacy and Data Security Team. Mrs. Ryan works with clients to identify and develop data protection plans; conduct vulnerability evaluations, mitigation strategies and remediation. Mrs. Ryan has counseled clients in a variety of industries on data privacy practices; regulatory compliance; and risk assessment matters.
Mrs. Ryan is a partner at the firm of Cipriani & Werner. Mrs. Ryan’s areas of concentration include life science …
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Method of Presentation:
Experience in data security and privacy law or healthcare law
NASBA Field of Study:
Information Technology - Technical
NY Category of CLE Credit:
Areas of Professional Practice
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About Butler Snow LLP
Butler Snow LLP is a full-service law firm with more than 330 attorneys representing local, regional, national and international clients from 22 U.S. offices and offices in London and Singapore. Ranked as a Top 10 firm for pharmaceutical client relations and one of America’s Top 100 law firms in the BTI Power Rankings, Butler Snow is recognized as one of the nation’s top law firms for client service. The firm was recently ranked 48th out of 650 firms in the BTI Client Relationship Scorecard for understanding our client’s business, anticipating client’s needs, unprompted communication, legal skills, quality and keeping clients informed. For more information, visit www.butlersnow.com or follow Butler Snow on twitter @Butler_Snow.
About Cipriani & Werner, PC
Cipriani & Werner, P.C. is a mid-Atlantic litigation law firm that is well established in the defense of businesses and insurers in the areas of life sciences, cyber security, premises, transportation, professional and general liability, workers’ compensation and employment matters, as well as construction and commercial litigation, bringing a consistent, aggressive persona to our practice in Pennsylvania, New Jersey, West Virginia, Delaware, Maryland, Baltimore and Washington, DC.
We have built our reputation upon our commitment to service. Our clients know that we consistently provide the most thorough and aggressive representation of their interests. Whether the attention is on the demands of the courtroom, or simply prompt communication with our clients, Cipriani & Werner, P.C. has survived and prospered primarily because of our ability to successfully provide such service.