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(202) 857-3376 Food and Drug Administration - Ophthalmic Digital Health Workshop 10/23/2017 Food and Drug Administration - Ophthalmic Digital Health Workshop 10/23/2017 Page 1 1 FOOD AND DRUG ADMINISTRATION 2 3 OPHTHALMIC DIGITAL HEALTH WORKSHOP 4 5 6 7 8 October 23, 2017 9 7:55 AM - 4:12 PM 10 11 12 13 14 2 Montgomery Village Avenue 15 Gaithersburg, Maryland 16 17 18 19 20 21 Reported by: KeVon Congo, 22 Capital Reporting Company www.CapitalReportingCompany.com (202) 857-3376 Food and Drug Administration - Ophthalmic Digital Health Workshop 10/23/2017 Page 2 1 C O N T E N T S 2 AGENDA ITEM: 3 FDA Welcome 4 Malvina B. Eydelman, MD 5 CDRH Efforts in the Digital Health Space 6 Jeffrey Shuren, MD, JD 7 Welcome from Cosponsoring Organizations 8 American Academy of Ophthalmology (AAO) 9 Michael Xavier Repka, MD 10 American Academy of Pediatrics (AAP) 11 Ken Nischal, MD 12 American Association for Pediatric 13 Ophthalmology and Strabismus (AAPOS) 14 Derek T. Sprunger, MD 15 American Society of Cataract and 16 Refractive Surgery (ASCRS) 17 Natalie A. Afshari, MD 18 American Society of Retina Specialists 19 (ASRS) 20 Mark S. Humayun, MD, PhD 21 Stanford Medicine Byers Eye Institute 22 David Myung, MD, PhD www.CapitalReportingCompany.com (202) 857-3376 Food and Drug Administration - Ophthalmic Digital Health Workshop 10/23/2017 Page 3 1 C O N T E N T S 2 (Continued) 3 AGENDA ITEM: 4 Accelerating Innovation To Encourage 5 New Frontiers in Ophthalmic Digital 6 Health 7 Zach Bodnar, MD 8 The Regulation of Digital Health 9 Bakul Patel 10 FDA Perspectives on Ophthalmic 11 Mobile Medical Applications and 12 Telemedicine 13 Ronald Schuchard, Ph.D. 14 Medical Device Data Systems 15 Krishna Yeshwant, MD, MBA 16 Telemedicine in Ophthalmology 17 Paul P. Lee, MD, JD 18 Telemedicine Diagnostic Challenges for 19 Diabetic Retinopathy: 20 Ingrid E. Zimmer-Galler, MD 21 Advanced Analytics in Ophthalmology: 22 Michael Chiang, MD www.CapitalReportingCompany.com (202) 857-3376 Food and Drug Administration - Ophthalmic Digital Health Workshop 10/23/2017 Page 4 1 C O N T E N T S 2 (Continued) 3 AGENDA ITEM: 4 Machine Learning in Ophthalmic 5 Diagnostics 6 Linda M. Zangwill, PhD 7 The Patient Interface with Digital 8 Health 9 John Reites 10 Question/Answer 11 BREAK 12 PANEL 1: Safety and effectiveness concerns when a 13 digital health device provides information as an 14 aid for diagnosis and the assets, threats, and 15 vulnerabilities to be considered and identified 16 (Questions 1 & 4) 17 MODERATORS: Natalie A. Afshari, MD 18 and Mike T. Trese, MD 19 PANELISTS: Dimitri Azar, MD; Leslie Bottorff; 20 David Morrison, MD; Darius M. Moshfeghi, MD; 21 Maria A. Woodward, MD, MS; 22 Ingrid E. Zimmer-Galler, MD www.CapitalReportingCompany.com (202) 857-3376 Food and Drug Administration - Ophthalmic Digital Health Workshop 10/23/2017 Page 5 1 C O N T E N T S 2 (Continued) 3 AGENDA ITEM: 4 LUNCH 5 PANEL 2: Safety and effectiveness concerns for an 6 ophthalmic digital health device used in a 7 clinical or non-clinical environment and the 8 assets, threats, and vulnerabilities to be 9 considered and identified (Questions 2 & 4) 10 MODERATORS: Mark S. Blumenkranz, MD; 11 Ken Nischal, MD 12 PANELISTS: Michael Abramoff, MD, PhD; 13 Michael Chiang, MD; Pravin U. Dugel, MD; 14 Michael H. Goldbaum, MD; Quinton Oswald; 15 Linda M. Zangwill, PhD 16 BREAK 17 PANEL 3: Effective safeguards and methods for 18 mitigating the risks for an ophthalmic digital 19 health device and the assets, threats, and 20 vulnerabilities to be considered and identified 21 (Questions 3 & 4) 22 www.CapitalReportingCompany.com (202) 857-3376 Food and Drug Administration - Ophthalmic Digital Health Workshop 10/23/2017 Page 6 1 MODERATORS: Mark S. Humayun, MD, PhD; 2 C O N T E N T S 3 (Continued) 4 AGENDA ITEM: 5 PANEL 3 (continued)" 6 MODERATORS: Mark S. Humayun, MD, PhD; 7 Derek T. Sprunger, MD 8 PANELISTS: Lama Al-Aswad, MD, MPH; Nitin 9 Karandikar, MD, PhD; David Myung, MD, PhD; 10 John Reites; Eitan Sharon, PhD 11 MODERATOR SUMMARIES FOR PANEL 1, 2, AND 3 12 Moderators from each Panel 13 CONCLUDING REMARKS 14 ADJOURN 15 16 17 18 19 20 21 22 23 www.CapitalReportingCompany.com (202) 857-3376 Food and Drug Administration - Ophthalmic Digital Health Workshop 10/23/2017 Page 7 1 P R O C E E D I N G S 2 DR. EYDELMAN: I m the Director of FDA's 3 Division of Ophthalmic and ENT Devices. I am 4 honored to welcome all of you to today's first 5 Ophthalmic Digital Health Workshop. 6 Digital technology has been revolutionizing 7 all of healthcare. Ophthalmology, with its ease 8 of obtaining anatomical images digitally, has been 9 inundated with opportunities to improve patient 10 care via digital health technology. My staff and 11 I are driven by our vision of bringing U.S. 12 patients safe and effective medical devices in a 13 timely fashion. Today's workshop, by fostering 14 innovation in ophthalmic digital health will help 15 us bring our vision to reality. 16 Before we start, I want to take this 17 opportunity to thank all of our six co-sponsoring 18 organizations for their hard work during a whole 19 year to make today's event possible. And now I'm 20 truly honored to introduce an individual who has 21 reinvented FDA's oversight of digital health 22 technologies. Dr. Jeffrey, our Center Director of www.CapitalReportingCompany.com (202) 857-3376 Food and Drug Administration - Ophthalmic Digital Health Workshop 10/23/2017 Page 8 1 Devices and Radiological Health will now share his 2 vision about ophthalmic -- about digital health 3 innovation plan. Thank you. 4 (Applause.) 5 DR. SHUREN: Thank you, Malvina. It's a 6 pleasure to welcome everyone to today's 7 conference. I also have to apologize and send 8 regrets on behalf of Dr. Gottlieb, our 9 Commissioner. So I was supposed to open up the 10 conference and he was supposed to end it. 11 Unfortunately, he is tied up in hearing prep all 12 day. I think he is testifying twice this week 13 before Congress starting tomorrow so, again, sends 14 his regrets, but this is an area of deep 15 importance to him and to myself. 16 As you heard from Malvina, there are 17 tremendous innovation that's going on and 18 opportunity for greater innovation due to digital 19 health technologies, I mean all the way from 20 enhancing existing functionalities, like the 21 opportunity to provide more precise placement of 22 ophthalmic implants to entirely new www.CapitalReportingCompany.com (202) 857-3376 Food and Drug Administration - Ophthalmic Digital Health Workshop 10/23/2017 Page 9 1 functionalities with learning systems and decision 2 support to greater connectivity, connecting 3 technologies so they can share information but 4 also impact each other's function, and then to 5 provide care remotely through telemedicine. 6 Now the north star for the Center for Devices 7 and Radiological Health at the FDA is our vision, 8 that patients in the U.S. have access to high- 9 quality, safe and effective medical devices of 10 public health importance first in the world. And 11 it's not about a competition between countries. 12 It's a recognition that we want medical devices to 13 provide benefit to patients but is of limited 14 value to patients unless they have timely access. 15 And first in the world is simply a good metric for 16 that. 17 Now we at the FDA face some challenges in 18 achieving that vision when it comes to digital 19 health technologies because the regulatory 20 paradigm, while risk-based, is also very product- 21 focused, and it was designed around hardware 22 technologies. And even as they evolved to have www.CapitalReportingCompany.com (202) 857-3376 Food and Drug Administration - Ophthalmic Digital Health Workshop 10/23/2017 Page 10 1 software, it was more as a component because 2 digital health technologies are different. And 3 when we talk about these technologies in the 4 international arena, the term we use for "medical 5 devices" is "software as a medical device" where 6 the technology truly is the software. So software 7 as a medical device, SaMD; and when it's in the 8 device as a component, it's Sims. So we think 9 about very different. 10 So hardware technologies; well, they have 11 rapid innovation but it's more around the order of 12 months to sometimes years and in very competitive 13 spaces, we'll see next generation technology about 14 every 18 months. You can learn a lot about 15 hardware technologies by looking at them, taking 16 them apart, kicking the tires, if you will. And 17 their impact on patients tends to be very direct 18 and observable. You can see changes to the 19 structure or the function or measurable biological 20 or physiological parameters. And the knowledge 21 that's generated about one device is often 22 transferrable to other devices within that www.CapitalReportingCompany.com (202) 857-3376 Food and Drug Administration - Ophthalmic Digital Health Workshop 10/23/2017 Page 11 1 category. 2 But when we deal with software, it's very 3 different. The innovation cycles are much faster. 4 There are new challenges, like cybersecurity. You 5 can't just look at software and have a good 6 understanding of what it's going to do. And when 7 you go ahead and test it, the impact may not be so 8 direct on patient health.
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