New Rules for Digital Health: How the Changing Regulatory Environment Presents New Opportunities for Digital Health Solutions
Over the last year, the federal government has taken significant steps to better support and manage the tidal wave of digital health solutions. Some of these initiatives - e.g., the 21st Century Cures Act and FDA's new digital health pre-certification program - are not only transformative for the government, but offer significant opportunities for entrepreneurs and mature businesses alike to more rapidly bring their solutions to market.
In this session, you will learn about how the regulatory environment is changing in ways that more fully embrace the unique qualities and power of digital health solutions.
1.) Stephanie Baum, Senior Editor at MedCity News
Stephanie is the Senior Editor for MedCityNews.com. She enjoys covering startups across health IT, mobile health, telemedicine, Internet of Things (IoT) and the convergence between health IT, medical devices, and drug development.
2.) Rohit Bansal, Director of Innovation Strategy - Digital Medicine at Otsuka
Supports Otsuka's digital medicine business to define digital medicine strategic vision and facilitate executive leadership alignment. Adapts Otsuka’s global digital business strategy to digital medicine portfolio strategy per strategic vision.
3.) Yuri Maricich, Chief Medical Officer at Pear Therapeutics
In September 2017, Pear received the FDA's first approval for a Digital Therapeutic and is a participant in the pre-cert pilot program.
Lisa Clark, Partner, Duane Morris
Lisa practices in the area of healthcare law with specific focuses in health information technology (HIT), regulatory compliance and reimbursement matters for hospitals (general acute care, substance abuse, psychiatric, and children’s), outpatient providers, post-acute care providers, physicians and other healthcare providers; software developers and investors in HIT and healthcare products and services; and subcontractors and vendors providing services to the healthcare industry.
- Impact of the 21st Century Cures Act on Digital Health - when do software solutions need/not need regulatory approval and what does that process look like?
- FDA's new digital health unit and it's pre-certification program...and what this means for you
- How the Changing Regulatory Environment Presents New Opportunities for Digital Health Solutions
Join the Philadelphia Health IT Circle on Thursday, January 18, 2018 to learn more from a panel of experts about how the evolving regulatory environment is creating new opportunities in digital health.