Biotech, medical device and pharmaceutical companies are actively developing digital health solutions to compliment current therapies. Their goal is to improve patient screening and diagnoses by integrating diagnostic capabilities and functions into smart phones and other mobile platforms.
Some of these products and solutions are regulated by FDA, CMS, FTC and others are presenting a new set of legal and regulatory challenges for industry and regulators.

This program is designed to provide biotech, medical device and pharmaceutical company professionals with in-depth and practical insights on the regulatory and policy issues that affect market entry, coverage and reimbursement and long-term success in this constantly evolving industry.

The following topics will be discussed during the course of this session:

• The evolution and trends for medical mobile apps, health IT, and wearable technology
• Regulatory issues associated with developing and marketing mHealth and Health IT products, including FDA premarket review and coverage and reimbursement issues
• Best practices for navigating FDA and CMS compliance and related risk management issues
• Best practices, strategies and trends and understand potential consequences for the company
• Emerging technologies on the horizon and related policy and legislative issues

Speakers:

Vernessa Pollard
Partner, Arnold & Porter LLP

Kenita Barrow
Corporate Attorney, Otsuka America Pharmaceutical, Inc.

Allison Shuren
Partner, Arnold & Porter LLP

Afia Asamoah
Product Counsel, Google