The FDA’s Cybersecurity Enforcement: Patient Care and Medical Cybersecurity Implications Uncovered
Vague requirements and a hot button political issue make for a volatile mixture as industry members try to comply with the U.S. Food & Drug Administration’s (FDA) cybersecurity requirements. The Agency, to date, has released four guidance documents outlining its proposed approach to cybersecurity enforcement, but has yet to demonstrate the degree of its resolve through enforcement activity. By taking apart and analyzing recent FDA action, the panel will inform viewers about the nuts and bolts of cybersecurity compliance.
FDA has made clear that health care facilities need to reassess their information security programs and ensure that these programs are comprehensive and updated. Applicable cybersecurity measures should also be taken to be able to address the vulnerabilities identified in the alert. Similarly, manufacturers of medical devices should carefully evaluate their products for potential security exposures. They should also offer security patches or, if needed, replacement products to their customers and ensure cybersecurity integration to product development.
In a two-hour LIVE webcast, a panel of distinguished professionals and thought leaders assembled by The Knowledge Group will provide guidance and suggestions to assist the healthcare industry in understanding the important aspects of this significant topic. They will provide an in-depth discussion of the FDA’s cybersecurity enforcement and its implications to the healthcare industry. Speakers will also offer best practices in developing and implementing effective information security programs in light of the most recent cybersecurity news.
Key topics include:
- The FDA Cybersecurity Enforcement – An Overview
- Cybersecurity Vulnerabilities of Medical Devices
- Implications to Healthcare Facilities and Medical Device Manufacturers
- Best Information Security Practices
- Regulatory Forecasts
Blake E. Wilson, Attorney
Hogan Lovells LLP
- FDA’s Current Paradigm for Cybersecurity Oversight
- What’s Driving the Cybersecurity Discussion
- FDA’s Expectations for Premarketing Submissions (and Beyond)
- Cybersecurity Failure from an FDA Post-Marketing Perspective
- FDA and Cybersecurity: What to Expect in the Future
Carolyn Purwin Ryan, Attorney
Cipriani & Werner, P.C.
- Draft Guidance Rules for Medical Devices
- Postmarket management of cybersecurity in medical devices
- Preparation and Vulnerability Assessments
Carol S. Doty, Partner
Kaufman Borgeest & Ryan LLP
- Cyber security issues and healthcare facilities (EHRs; telemedicine and risks associated with use of this technology)
- HIPAA issues (Healthcare facilities and cyber risk)
- Anticipated risks for the future of healthcare facilities.
Who Should Attend:
- Healthcare Law Attorneys
- Privacy and Data Security Lawyers
- Health Industry Advisors
- Healthcare Consultants
- Healthcare Service Providers
- Directors from Hospitals
- Hospital Technicians
- Data Security Professionals in Healthcare Facilities
- Privacy & Data Management Officers in Healthcare Facilities
- Other Related/Interested Professionals and Organizations
Mr. Wilson's practice focuses primarily on medical device regulatory matters, with an emphasis on the premarket clearance and approval of new medical devices, and clinical investigations. Mr. Wilson also has experience in post-market compliance and enforcement matters, as well as drafting clinical trial agreements and other medical device related commercial contracts. Recently, Mr. Wilson was a guest speaker at the Indo-Global Conference in Hyderabad, India, where he presented on FDA’s medical device regulatory framework.
Mr. Wilson obtained his J.D. from the University of Pennsylvania Law School, along with a Certificate in Business Economics and Public Policy from the Wharton School of Business. He obtained his B.S., summa cum laude, from Northeastern University. Prior to pursuing his law degree, Mr. Wilson worked as a lead research assistant at Brown University, where he managed pharmaceutical clinical trials.
Mr. Wilson's practice focuses primarily on medical device regulatory matters, with an emphasis on the premarket clearance and approval of …
Mrs. Ryan’s areas of concentration include life science litigation, products liability, food contamination, 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. Mrs. Ryan is a member of the Information Privacy and Data Security Team. She serves as national counsel for domestic and international companies.
Mrs. Ryan’s areas of concentration include life science litigation, products liability, food contamination, cyber security and medical malpractice litigation. She …
Carol S. Doty is a Partner concentrating in the fields of medical malpractice litigation, risk assessments for healthcare practitioners and institutions, and a member of the firm’s Cybersecurity Practice Team. She has defended hospitals and licensed medical professionals in malpractice and products liability claims and has represented physicians and nurses in disciplinary actions in Connecticut and New York. In addition to litigating medical malpractice and products liability claims, Ms. Doty has extensive experience in various healthcare-related issues, including risk management, quality assurance and regulatory matters, both at the State and Federal level. Ms. Doty’s practice also includes the defense of management in employment cases, the representation of insurers in complex insurance coverage issues, and litigation involving nursing home liability claims in a nationwide program.
Ms. Doty has been the featured speaker on various cyber and health law topics, including introduction to cyber security threats and federal regulations, updated case law and risk-related issues with respect to EMR’s, defense of allied professionals, health care power of attorneys, health care proxies, living wills and advanced directives. Prior to beginning her legal career, she practiced as a certified Critical Care Registered Nurse and Clinical Instructor.
Ms. Doty is admitted in Connecticut, New York and the District of Columbia, and is also admitted to the United States District Court of Connecticut, and the Southern and Eastern Districts of New York. She is a member of the Connecticut Bar Association (Litigation Section), New York State Bar Association (Health Law Section) and of the American, Connecticut and New York Societies of Health and Risk Management (ASHRM). She has earned the International Association of Privacy Professional (IAPP) credentials for the United States (CIPP/US).
Ms. Doty is a graduate of Pace University School of Law School and Duke University.
Carol S. Doty is a Partner concentrating in the fields of medical malpractice litigation, risk assessments for healthcare practitioners and …
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About Hogan Lovells LLP
Hogan Lovells LLP is a multinational law firm with over 2,500 attorneys and more than 40 offices throughout the U.S., Europe, Latin America, the Middle East, Africa, and Asia. In the Medical Device group, we help clients mitigate risks and pursue opportunities through timely, effective counsel on matters relating to the entire medical device life cycle. Our clients include local, regional, and global developers; manufacturers; researchers; investors; and trade associations. Many of our lawyers and regulatory science professionals have worked for regulatory agencies and in private industry, and have advanced degrees in relevant scientific or technological areas. We advise clients on all aspects of regulation involving the U.S. Food and Drug Administration (FDA), the European Union, and other local, national, and international regulatory entities.
During 2015, Who’s Who Legal named Hogan Lovells as the top Global Life Sciences Practice, LMG Life Sciences listed the Firm’s FDA Medical Device practice (North America) in High Recommendation, and Chambers Global placed Hogan Lovells’s Life Sciences practice in the ranking’s 1st Tier for the second year running.
About Cipriani & Werner, P.C.
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.
About Kaufman Borgeest & Ryan LLP
Kaufman Borgeest & Ryan LLP was founded in 1997 by a group of experienced and nationally-recognized defense attorneys dedicated to providing the highest quality legal services to domestic and international clients. The firm has grown gradually but consistently since its inception, and presently has over 120 attorneys practicing out of 6 offices in New York, New Jersey, Connecticut and California, in over 30 different practice areas. Our growth has been built upon the strength of our reputation for excellence, our ability to deliver cost-effective, resolution-oriented services, and in our innovative and responsive attention to the needs of our clients.
Our cyber liability practice is focused on the ever-increasing risks and rapidly evolving liability exposures associated with the creation, transmission, security and storage of data, particularly private, personal and proprietary information. Today’s businesses face the threat of hackers trying to steal data, and the accidental disclosure of such information – or loss of such information – can give rise to liabilities to customers, clients and the government. We work with our clients to identify and advise on strategies to address and minimize potential legal liabilities, while protecting and enhancing the efficacy of our clients’ internet operations and network reputation.