FDA Regulation of Digital Health – Current Status and Recent Developments

01:00 PM ET | 10:00 AM PT | 12:00 PM CT Duration 60 Minutes

Webinar Includes : All the training handouts , certificate ,Q/A and 60 mins Live Webinar

"ear By David R. Dills, he is currently the Director of Regulatory Services at CROMSOURCE, an international contract research organization H"

FDA focusing on Digital Health?

Description

Why is the FDA focusing on Digital Health? Many medical devices now have the ability to connect to and communicate with other devices or systems. Devices that are already FDA approved or cleared are being updated to add digital features. New types of devices that already have these capabilities are being explored. Many stakeholders are involved in digital health activities, including patients, health care practitioners, researchers, traditional medical device industry firms, and firms new to FDA regulatory requirements, such as mobile application developers. The broad scope of digital health includes categories such as mobile health (mHealth), health information technology (IT), wearable devices, telehealth and telemedicine, and personalized medicine. Health information technology (HIT) presents tremendous benefits to the public, including greater prevention of medical errors, improved efficiency and health care quality, reduced costs, and increased consumer engagement. However, if HIT is not designed, developed, implemented, maintained, or used properly, it can pose risks to patients.

FDA does not intend to enforce compliance with the regulatory controls that apply to certain MDDS devices. Medical Device Data Systems (MDDS) are hardware or software products that transfer, store, convert formats, and display medical device data. An MDDS does not modify the data or modify the display of the data, and it does not by itself control the functions or parameters of any other medical device. MDDS are not intended to be used for active patient monitoring. These systems are the foundation for intercommunication and interoperability among devices and between medical devices and other health IT. Because they pose such a low risk, FDA does not intend to enforce compliance with the regulatory controls that apply to medical device data systems. FDA believes that this will encourage greater innovation in the development and maturation of these systems. Providers and other stakeholders are using digital health in their efforts to: Reduce inefficiencies; improve access; reduce costs; increase quality, and, make medicine more personalized for patients. Patients and consumers can use digital health to better manage and track their health and wellness related activities. The use of technologies such as smart phones, social networks and internet applications is not only changing the way we communicate, but is also providing innovative ways for us to monitor our health and well-being and giving us greater access to information. Together these advancements are leading to a convergence of people, information, technology and connectivity to improve health care and health outcomes.

Objectives:

•        Share CDRH's perspective and approach on Digital health guidance's
•        Clarify final MDDS guidance and the updated Final Mobile Medical Apps guidance
•        Mobile apps under enforcement Discretion
•        Background with General Wellness Guidance
•        FDA enforcement discretion and areas of focus
•        Addressing Cybersecurity threats, and thus reducing information security risks

Why Should you Attend:

•        Provide regulatory clarity by using focused regulatory oversight
•        Why is the FDA focusing on Digital Health?
•        Mobile apps not medical devices
•        Mobile apps not focus on oversight
•        Classification of your 'device' and proven regulatory strategies for digital health technologies
•        Wireless Medical telemetry medical devices and regulatory expectations

Areas Covered

•        Wireless Medical Devices
•        Mobile medical apps (MMA)
•        Health IT
•        Telemedicine
•        Medical Device Data Systems
•        Medical device Interoperability
•        Software as a Medical Device (SaMD)
•        General Wellness
•        Cybersecurity
•        Industry Guidance and Resources

Who will Benefit

•        Regulatory Affairs Management
•        Regulatory Affairs Specialist
•        Auditors
•        Compliance Officer
•        Compliance Specialist
•        Clinical Affairs
•        Quality Assurance Management
•        Marketing & Sales
•        Software Design Engineering
•        Software Quality Engineering
•        Distributors/Authorized Representatives
•        Legal Counsel
•        Design Engineering/Technical Services
•        Operations/Manufacturing
•        Consultants

Industries who can attend

This 60-minute online course is intended for professionals in the Medical Device, Biotechnology,Pharmaceutical Industry. Although not presently stated in the draft , the same guide could be used by FDA Regulated Industries personnel

 


Speaker Profile

David R. Dills

David R. Dills, is currently the Director of Regulatory Services at CROMSOURCE, an international contract research organization (CRO to the pharmaceutical, biotechnology, and medical device industries. Mr. Dills has more than 28 years of experience in the medical device and pharmaceutical industry. He has held positions of increasing responsibility with sponsor and service companies of various sizes, including large, global OEM’s/sponsors, consultancies and a global CRO, as well as virtual, small, mid and large-sized enterprises and has serviced sponsors and clients in multiple global locations. Mr. Dills’ most recent position was President and Principal, Global Regulatory Affairs Consultant with a consultancy in the US, and prior to that he served in senior level regulatory and compliance roles for various organizations. He has a range of expertise in different therapeutic areas and medical specialties for pharma and medical devices, including combination products. David enjoys interpreting the regulatory precedents and new legislation, developing the regulatory strategy as part of strategic regulatory consulting, Agency meeting preparation and engagement, conducting persuasive communication with regulatory authorities, executing an effective path to approval for submissions and marketing applications with multi-country registrations and approvals, developing GxP compliance strategies from premarketing to postmarketing from R&D, Manufacturing/Operations, Postmarket and to delivering regulatory and compliance training to internal and external stakeholders, and striving for overall corporate compliance with regulations in The Americas, EMEA and Asia Pacific. He has managed regulatory and compliance projects with multiple competing priorities having a direct impact on site operations commercial opportunities and enjoys adding business value to clients by providing strategic and tactical solutions that facilitate the achievement of regulatory and com

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