Escape Room Challenge: Legal and Regulatory Considerations for a Healthcare Technology Product Launch (AM24)
Recorded On: 10/08/2024
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Collaborate with your peers across legal and regulatory disciplines to develop a compliant strategy for a healthcare technology product launch before your time runs out! Communicate to identify issues, assess and mitigate risks, complete tasks, and solve a variety of complications while remaining compliant. Boost your skills in communication, project management, issue spotting, and advising on matters such as intellectual property, access to data, and privacy laws that affect the company’s products and services as well as advising them on compliance with regulations governing technology products - all within an impending deadline.
Key:
Melissa Hoffman
VP, Regulatory Corporate Counsel
Edwards Lifesciences Corporation
Licensed California attorney with over 16 years of experience, including 9 years of in-house experience with three multinational MedTech companies as well as experience with large (AM Law 100) and mid-sized law firms.
Broad legal experience with a foundation of transactional corporate and securities law, evolving to include several additional areas of expertise, including contract team management, commercial support, product launches, advertising and promotion, healthcare regulatory compliance, dispute management, and strategic intellectual property issues.
Strong leadership experience as a current member of one of Edwards’ Business Unit leadership teams, its Legal Department leadership team, and a US Commercial and Sales leadership team.
Effective communicator and relationship builder who understands that legal leadership requires a deep understand of the business and a willingness to partner to identify creative solutions while effectively managing risk (and often a healthy sense of humor).
Core competencies include:
* Medical device regulatory
* Compliance
* Clinical trials
* Contract drafting and negotiation
* Securities
* M&A
* Financing transactions
* Fraud and abuse
* Advertising and promotion
* Corporate governance
* Dispute management
* Business and legal strategy
Sean Vargas-Barlow
Senior Counsel
Paragon Legal
As a senior legal leader in various multinational companies, I have successfully guided business leaders and other internal stakeholders in managing privacy, security, data, and AI risks in service offerings and company programs by providing creative and compliant risk mitigation strategies. I have substantial experience in collaborating with business teams in all stages of product development and provide value by advising teams on how to build privacy by design into product and service offerings.
I am also a Certified Information Privacy Professional (CIPP/US/C/E/G), Certified Information Privacy Manager, and Certified Information Privacy Technologist. I am admitted to the Illinois Bar.
With a strong interest in coaching others to leverage their strengths and build relationships, I have conducted seminars on mindfulness, how to manage failure and take risks, and interpersonal effectiveness. I have also served as a volunteer for the ABA's GRIT Project, which is an initiative to educate women lawyers about the importance of grit and having a growth mindset for career development.
Specialties:
- International global privacy, data security such as GDPR, CCPA, LGPD, PIPEDA, and PIPL
- Knowledge of multi-jurisdictional laws and practices in the field of emerging technologies such as Internet of Things, AI/ML, blockchain, and biometrics
- Privacy by Design
- Data Governance
- Security
- Contract Drafting and Negotiation of Data Protection Agreements
- Privacy Trainings and Guides
- AI Ethics
- Intellectual Property
Holly Vu-Fulkerson
AD and Senior Counsel
Cognizant Technology Solutions
Detail-oriented and solution-focused healthcare regulatory attorney with privacy, data security, and revenue cycle experience at a Fortune 200 global technology company operating in a heavily regulated digital health platform space. Diligent self-starter with the ability to manage competing priorities and see projects through to completion. Extensive experience with healthcare regulations for providers and payers, HIPAA/HITECH data security compliance, commercial contracts, revenue cycle management, and debt collection for 15 years as in-house counsel with a litigation background. Experience supporting a Business Unit within a highly complex matrixed organization.
Eric L. Sophir
Partner
Foley & Lardner LLP
Eric Sophir develops and implements strategies that obtain, protect, and monetize meaningful patents for startups to Fortune 50 companies.
An intellectual property partner with Foley & Lardner LLP, Eric counsels clients on protecting innovations gaining market share the risks and value associated with acquiring, licensing, or otherwise commercializing a patent portfolio resolving patent disputes and monetizing patents. His practice includes patent preparation and prosecution; infringement and validity analysis in patent litigation; licensing and selling; due diligence; clearance and landscape analysis; and post-grant proceedings. He also advises on prosecution strategies to better protect a product or more effectively deter competitors. His practice emphasizes portfolio development, including invention harvesting and patent filing strategies.
Eric has litigation experience and handles complex patent disputes at the federal district courts and Federal Circuit, arbitration, and re-examination proceedings. He also conducts analyses and prepares opinions regarding patent infringement, invalidity, and enforceability. Eric counsels clients in offensive and defensive actions involving competitors as well as non-practicing entities (NPEs).
According to Chambers USA, “Eric is a very strategic and thoughtful lawyer who is exceptional at what he does.”
While studying engineering at Cornell University, Eric conducted research for Professor L. F. Eastman regarding the growth and use of gallium nitride, a III-V semiconductor. One aspect of the research was attempting to grow a semiconductor that would emit a wavelength suitable for blue light.