The Translational Research Institute for Biomedical Engineering and Science (TRIBES) invites you to

Mobile Apps and Clinical Decision Support Technology: Developing Practical Compliance Strategies with Evolving Requirements and Multiple Regulators

October 10, 2012 | 2:00-3:30pm ET

Marcus Nanotechnology Building | Room 116

The demand for personalized care, greater cost-savings, flexibility, interactivity, and portability in health delivery systems, records management, and treatment are driving innovation. The sheer number, variety and complexity of products that have been, and are being developed have led the Food and Drug Administration, Federal Communications Commission, Centers for Medicare and Medicaid Services and other regulators to issue new regulations, guidelines, and approvals.

The convergence of wireless and medical technologies is changing the way consumers and healthcare providers manage health and treat disease. Pharmaceutical and medical device manufacturers, insurers, software developers, and physicians are partnering with network providers to offer Health IT solutions to provide greater flexibility, connectivity, and interoperability in the delivery of health care, health education, and patient self-care services. The number of health and wellness apps, clinical decision support technology, and other integrated diagnostic devices on the market has increased exponentially in the past year.

Join us for this Free interactive panel with some of the industry’s top experts to help guide you through the regulatory landscape for Mobile Apps and Clinical Decision Support Technology.

What you will learn

Your regulatory experts Vernessa Pollard, Allison Shuren, Maureen Jeffreys and Nancy Perkins of Arnold & Porter LLP will explain how many of these products and solutions are currently regulated by the FDA, FCC, CMS, the Health and Human Services Department’s Office of the Inspector General and Office for Civil Rights, and others, and the new legal and regulatory challenges they present for industry and regulators. This webinar will provide you with:

• An overview of the regulatory landscape: FDA, FCC, CMS, and data privacy and security regulations
• Recent legislative and regulatory developments
• A look to the future: what’s on the horizon
• Practical guidelines to manage compliance and regulatory obligations

Your Experts

Vernessa Pollard is a partner in Arnold & Porter LLP's FDA and Healthcare group, principally focusing on regulatory matters involving the US Food and Drug Administration and US Department of Justice (DOJ). She advises companies on regulatory, compliance, enforcement, and legislative matters involving pharmaceuticals, medical devices, cosmetics, food, and medical technology and software. She regularly counsels companies on product approvals, Good Manufacturing Practice (GMP) and Quality System (QS) requirements, advertising and promotion, adverse event reporting, FDA Warning Letters, FDA inspections, recalls, import detentions, and corporate compliance programs. She has represented companies and executives in FDA and DOJ investigations and enforcement matters. The National Law Journal named her one of the 2011 Minority 40 under 40.

Allison Shuren is a partner in the FDA/Healthcare group of Arnold & Porter LLP. Her practice focuses on healthcare regulatory issues, including fraud and abuse counseling and investigations involving allegations under the False Claims Act, Anti-Kickback Statute, and the Stark Law; implementation and audit of corporate compliance programs and government imposed corporate integrity agreements; counseling regarding joint ventures and complex contractual arrangements with referral sources; and assisting clients launching innovative technologies navigate the complex coding, coverage, and payment landscape. Ms. Shuren has been ranked in Chambers USA: America's Leading Lawyers for Business since 2007 and recently named a Life Science Star in LMG Life Sciences 2012.

Maureen Jeffreys is a partner in the Telecommunications, Internet and Media group of Arnold & Porter LLP. She provides regulatory, compliance, enforcement, transactional, and litigation counseling to wireline, wireless, cable television, media, and Internet clients. She represents these clients before the Federal Communications Commission (FCC), the National Telecommunications and Information Administration (NTIA), and elsewhere. Ms. Jeffreys regularly counsels clients regarding the regulatory implications of emerging trends in the communications ecosystem, including recent developments in mobile health.

Nancy L. Perkins, counsel in the Data Privacy and Security group of Arnold & Porter LLP, has an extensive practice in the regulation of privacy and security of personal information. She has particular expertise with the privacy, security, breach notification, and enforcement regulations implementing the Health Insurance Portability and Accountability Act (HIPAA), the Health Information Technology for Economic and Clinical Health (HITECH) Act, and the emerging body of regulatory actions governing data privacy and security with respect to mobile applications. Nancy has been ranked consistently by Chambers USA as a “Leading Individual” for Privacy & Data Security and has published numerous articles in the area, including "Expanded Liability For Health Data Uses and Disclosures: What New Risks Loom Under the Proposed Privacy and Security Rules Implementing the HITECH Act?" Bloomberg's Privacy & Information Law Report, Vol. 3, No. 9, September 2010, and "Proposed U.S. HITECH Act Data Privacy And Security Rules: How Would They Impact Pharmaceutical Companies?" BNA Privacy & Security Law Report, Pharmaceutical Law & Industry Report, and International's World Data Protection Report. August 2010.

Please join us for what should be an informative session.