FDA Regulation of Digital Health - Current Status and Recent Developments

Duration: 60 Minutes
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 Regulation of Digital Health
Instructor: David R Dills
Product ID: 501646
Objectives of the Presentation
  • 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
Topic Background
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.
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Instructor Profile:
David R. Dills, is an independent Global Regulatory Affairs & Compliance Consultant and has an accomplished record with more than 26 years of experience in regulatory affairs, compliance and quality consultative services for early-stage/established Class I/II/III medical devices, IVD's, and bio/pharmaceutical manufacturers on the global landscape. Previously employed, with increasing responsibilities by device manufacturers and consultancies, including a globally recognized CRO, has worked directly with and for manufacturers engaged in compliance remediation activities involving consent decrees, CIA's, FDA warning letters, and customer generated compliance events, provides Strategic GxP Compliance and Regulatory Consulting, handles all aspects of global regulatory submissions and dossiers, including 510(k), PMA and IDE submissions, serves as a U.S. Agent, works with stakeholders and Center Reviewers regarding submission meetings/negotiations, clinical affairs, and provides regulatory submissions and post-market project leadership/guidance covering different therapeutic and medical specialties based on classification. Background encompasses broad capabilities in regulatory and compliance oversight and governance, regulatory and GxP training, and compliance with MEDDEV/MDD/IVDD Directives. Mr. Dills leads and manages efforts involving multi-country product registrations and licensing in Asia Pacific, EU and The Americas from premarketing to postmarketing, and works with the Regulatory Authorities and strives to provide consistent, practical compliance solutions that work with reduction of regulatory compliance risk.
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