Risk based 12/1/2015. Digital Health Bakul Patel Associate Director for Digital Health Office of Center Director.

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1 Digital Health Bakul Patel Associate Director for Digital Health Office of Center Director Center for Devices and Radiological Health 1 Oversight Approach Platform independent Promote innovation Promote patient engagement Protect patient safety Functionality focused Narrowly tailored Risk based 2 CDRH DIGITAL HEALTH PROGRAM Software Telemedicine Interoperability Device Data Systems Wireless Devices Health IT Mobile Health General Wellness Develop and implement consistent regulatory strategies and policies for digital health technologies 1

2 No regulatory requirements Mobile Apps (MMA) Patient self management apps Tools to organize and track their health information (not for treating or adjusting medications) Tools to access to health information document and communicate with health care providers Tools that automate simple health care providers tasks Enforcement Discretion MMA Lower risk mobile apps that meet device definition but not considered MMA Mobile apps not considered medical devices focus of oversight Mobile apps that meet device definition that are either intended To be used as an accessory to already regulated medical device, or To transform a mobile platform into a regulated medical device. 4 Mobile Apps (not considered MMA) Mobile apps NOT Devices Library of clinical descriptions flash cards Certification or recertification preparation apps; Games to train health professionals in advanced CPR skills. Allow users to input pill shape, color or imprint and displays pictures and names of pills that match this description; Find the closest medical facilities; Help guide patients to ask appropriate questions to their physician Track, review and pay medical claims and bills online; Manage or schedule hospital rooms or bed space Mobile apps NOT Focus of Oversight Help patients (i.e., users) self-manage their disease or conditions without providing specific treatment or treatment suggestions; Provide patients with simple tools to organize and track their health information; Provide easy access to information related to patients health conditions or treatments; Help patients document, show, or communicate potential medical conditions to health care providers; Automate simple tasks for health care providers; or Enable patients or providers to interact with Personal Health Record (PHR) or Electronic Health Record (EHR) systems. 5 MDDS Final Guidance (Feb 9, 2015) The FDA does not intend to enforce compliance with the regulatory controls that apply to the following devices: MDDS subject to 21 CFR , image storage devices subject to 21 CFR , and image communications devices subject to 21 CFR MDDS does not include -- A. Products that are intended for active patient monitoring i.e. clinical context requires a timely response The clinical condition (disease or diagnosis) requires a timely response B. Modifies the medical device data, and C. Control the functions or parameters of any connected medical device. 6 2

3 Updated MMA Guidance (notable changes) (Feb 9, 2015) Mobile Apps Further narrows apps defined as MMA Mobile apps that are an extension of one or more medical devices by connecting to such device(s) for purposes of controlling the device(s) or for use in active patient monitoring or displaying, storing, analyzing, or transmitting patient-specific medical device data. Mobile apps under enforcement Discretion Includes MDDS -- Intended to transfer, store, convert format, and display medical device data in its original format from a medical device (as defined by MDDS regulation OUG). Examples previously added to website 7 CDRH/FDA Ongoing Activities Post market surveillance Regulatory clarity Premarket expectations Post market expectations Stake holder collaboration Device industry Healthcare organization Federal partners Researchers & experts Enable a platform for maintaining Cybersecurity Awareness 8 FDA Cyber-security Goals Raise cyber-security awareness leverage knowledge from other industry sector Promote safety and security by design by clear regulatory expectation Promote proactive vulnerability management Minimize reactive approaches 9 3

4 Efforts and Collaborations Guidance Premarket (Draft, 2013) Wireless Technology (2013) CS for Networked Devices with OTS Software (2005) Recognition of Standards Cybersecurity (2013) Interoperability (2013) 10 IMDRF Goals International convergence and common understanding of Software as a Device (SaMD): Generic types of SaMD Generic risks of SaMD that affect public health Expectations of controls required to minimize generic risk Establish a framework for regulators to incorporate converged controls into their regulatory paths or classifications. 8/15/14 11 Software as a Device (SaMD) Aligning vocabulary SOFTWARE INDUSTRY REGULATORS, STANDARDS 12 4

5 KEY Concepts SaMD definition is platform-agnostic Intended Purpose. Intended Purpose. Intended Purpose. SaMD can run on dedicated platforms, medical devices, general-purpose PCs, mobile platforms, cloud services, etc. WHAT it does is more important than WHERE it is 13 Catastrophic SaMD Framework Impact Very None Low Medium High High Not SaMD I I I II II II III III IV Not SaMD (Part of MD / Embedded in MD) Retrieves Optimizes Informs Informs Treat/ Treat/ Closed Loop information Process serious critical Diagnoses Diagnoses Interventions Decisions Decisions non serious serious No Clinical Intermediary Organizes Informs nonseriouserious serious critical diagnoses Drives non- Drives Drives Treats/ Data Decision Decisions Decisions Decisions critical Functionality SaMD Quality Management Principles A grouping of QMS activities from a Software perspective A governance structure provides leadership, accountability and an organization with adequate resources that assures the safety, effectiveness and performance of SaMD; SaMD lifecycle processes -- A scalable set of quality processes that apply commonly across lifecycle activities; A set of key lifecycle activities that is scalable for the type of SaMD, the size of the organization takes into account important elements required for assuring the safety, effectiveness and performance of SaMD. Leadership and organizational support provides a foundation for SaMD lifecycle processes SaMD lifecycle processes support and apply across the SaMD lifecycle activities. 5

6 Digital Health Summary FDA s Policies Drive Towards Beneficial to drive better health outcomes Enables patients empowerment Enables efficient health care processes and decisions Promoting patient engagement technologies Providing regulatory clarity by using focused regulatory oversight Understanding and addressing stakeholder needs and expectations 16 Addressing evolving Mobile apps landscape Web page for mobile medical apps FDA, on this website intends to have a list of example types that we intend to exercise enforcement discretion, regulate or have considered not devices. Provide internal coordination to maintain consistent policy decisions related to mobile medical apps Questions related to mobile medical apps or Digital health MobileApps@fda.hhs.gov or Digitalhealth@fda.hhs.gov

7 CDRH DIGITAL HEALTH PROGRAM Software Telemedicine Interoperability Device Data Systems Wireless Devices Health IT Mobile Health General Wellness Develop and implement consistent regulatory strategies and policies for digital health technologies 7