CATALYSTS DRIVING SUCCESSFUL DECISIONS IN LIFE SCIENCES REGULATORY IMPACT ON THE FUTURE OF MHEALTH WEARABLES BY DR. JESSICA SANTOS

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1 CATALYSTS DRIVING SUCCESSFUL DECISIONS IN LIFE SCIENCES REGULATORY IMPACT ON THE FUTURE OF MHEALTH WEARABLES BY DR. JESSICA SANTOS SEPTEMBER 2016

2 REGULATORY IMPACT ON THE FUTURE OF mhealth WEARABLES PAGE 2 MHEALTH WEARABLES ENABLE A FUTURE IN WHICH HEALTHCARE PROFESSIONALS HAVE GREATER CONNECTIVITY WITH PATIENT CARE. As people worldwide are becoming more educated consumers of healthcare, the healthcare and technology industries have partnered to focus on and improve health by developing web-connected mobile health (mhealth) devices to help consumers track everything from how much sleep they get to how many steps they take to what their blood pressure or glucose levels are. Topics such as digital health, mhealth, wearables, health apps and web-connected mobile devices are the latest technology trends to explode 1. For the purposes of this white paper we will refer to this category as mhealth wearables. Although in limited use today, mhealth wearables enable a future in which healthcare professionals have easy access to relevant patient health data and greater connectivity with patient care. So are these mhealth wearables consumer products, toys or medical devices? At the moment, mhealth wearables are being marketed as consumer products with health benefits. Because of this, the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) have not been as heavily involved in regulating this market as they are with pharmaceutical drugs or medical devices. THE FDA S CURRENT POSITION ON WEARABLES The FDA is generally welcoming mhealth wearables to the market 2 because of their goal to improve general wellbeing. The Department of Health and Human Services (HHS) accepts the new wearables wave as a driver for the value-based healthcare principle in the Affordable Care Act 3. Because this law gives doctors and hospitals financial incentives for keeping large groups of patients healthy, mhealth wearables are a useful tool for collecting data on how healthy patients are. Consumers, doctors and payers all want to know whether mhealth wearables actually provide a clinical benefit. Conducting clinical trials and submitting data to the FDA is one method to document the clinical evidence of wearable benefits. That clinical documentation and the resulting approval from the FDA will allow manufacturers to market their devices as providing a medical benefit. As the FDA determines how to regulate health trackers and the tech industry lobbies the agency, some think the FDA does not want to regulate wearables and device makers want to keep it that way because so many apps and devices are already on the market or in development 4. Indeed, the guidance the FDA has already issued suggests it won t regulate products and apps used to track general wellness. 5 The FDA s guideline on General Wellness: Policy for Low-Risk Devices (2015) 6 is a non-binding proposal that describes the agency s thinking on regulation of devices such as mhealth wearables. The guidance effectively suggests the agency will not vigorously regulate devices as long as they are not harmful and generally encourage healthy habits. Many devices with less-than-stellar track records for accuracy such as calorie counters would likely not be covered under the guidance. In the short term, the FDA will not focus its enforcement efforts on mhealth wearables because they are positioned as improving general wellness only, according to Bakul Patel, associate director for digital health at the FDA. 7 The agency is seeking to advance public health through promoting innovation and development in this area by continually adapting its regulatory approach to technological advances to meet the needs of patients and consumers. However, the comments on this guideline show that some of the world s biggest tech industry groups and companies are pushing the FDA to make the lax regulations more explicit. 8

3 REGULATORY IMPACT ON THE FUTURE OF mhealth WEARABLES PAGE 3 REGULATORS WANT TO DETERMINE WHETHER MHEALTH WEARABLES CONTRIBUTE TO GENERAL WELL- BEING AND IMPROVE PUBLIC HEALTH. Medical Device Data Systems (MDDS) 9 confirm the FDA s intention to not enforce compliance with applicable regulations for technologies that receive, transmit, store or display data from medical devices. The Mobile Medical Apps Guideline 10 is consistent with the MDDS position. The FDA has proposed not to impose heavy regulatory compliance for lowrisk products that are intended only for general wellness. 11 If an mhealth wearable is intended to be used with a parent device (for example, receiver monitors) and is on the level of regulated controls (i.e., all data and performance will be monitored and inspected), it is necessary to ensure their safety and effectiveness, which is independent of the risks of their parent devices. The FDA s guideline on Medical Device Accessories: Defining Accessories and Classification Pathway for New Accessory Types 12 was drafted based on the risks mhealth wearables present when they were positioned as accessories instead of standalone medical devices. Some accessories can have a lower risk profile than their parent device and, therefore, may warrant being regulated as being in a lower class. For example, an accessory to a Class III parent device may pose a lower risk that could be mitigated through general or special controls and thus could be regulated as a Class I or Class II device. The Federal Trade Commission (FTC) is allowed to target companies outside the FDA s jurisdiction and has investigated claims by manufacturers of mhealth wearables. The FTC recently sued Lumos Labs on the grounds it was making deceptive claims related to a product that promised to improve cognitive function without the scientific evidence to back them up. 13 But will mhealth wearables remain products for general well-being forever, and will the stakeholders want it to be more strictly regulated in the future? WILL MHEALTH INDUSTRY BENEFIT FROM BEING REGULATED AS MEDICAL DEVICES? What impact might greater regulation has on the different constituents in the mhealth market is still up for debate. Unlike pharmaceutical products, where the target audience is typically physicians, the audience in the mhealth wearables market is healthcare consumers. MANUFACTURERS Manufacturers currently have very little incentive for involving health regulatory authorities, which allows a low entry point to the wearables market. When competition becomes more intense, tighter regulations can remove competition, and smaller, more nimble competitors who cannot afford to go through the regulatory process will be eliminated. Moreover, regulation would protect legitimate companies from having their reputation hurt by competitors whose products don t actually work. REGULATORS Regulators primary responsibility is to protect the public health by ensuring the safety, effectiveness, quality and security of medical products. 14 The FDA and FTC pose two very important questions: Is the mhealth wearable safe, and are the data collected from the product accurate? 15 Further, regulators will want to determine whether mhealth wearables contribute to general well-being and improve public health. 16 Manufacturers must prove that mhealth wearables are safe and effective (FDA) and accurate (FTC) for regulators to approve them as health products.

4 REGULATORY IMPACT ON THE FUTURE OF mhealth WEARABLES PAGE 4 THE MOST EFFECTIVE ACTION FOR WEARABLES MANUFACTURERS IS TO SELF-REGULATE AND IMPOSE HIGH QUALITY STANDARDS. PHYSICIANS Evidence suggests that the number of consumers purchasing wearables after recommendations from their physicians may increase with regulation. According to Kantar Media Physicians Sources and Interactions Study, 21% of healthcare providers strongly agree they would recommend wearables only if they are FDA approved. 17 This gives manufacturers some incentive to pursue approval from a regulatory body like the FDA or EMA. CONSUMERS Will consumers welcome more regulated wearables? Most consumers would certainly prefer devices that deliver more accurate, reliable data from trusted providers that have gone through regulatory inspection. However, they might not welcome the higher price that comes with regulation. THE FUTURE OF WEARABLE DEVICES If the FDA or EMA starts to more heavily regulate the wearables industry, they would need to decide where mhealth wearables fit. Would they be a Class III medical device, or a consumer product like electric toothbrushes? 18 Classification would influence pricing, approval time and how quickly the product gets to market. Manufacturers are not satisfied with wearables being positioned for only general well-being for example, The Fitbit of the future won t just track your steps, it ll save your life. 19 Fitbit is developing advanced sensors and moving forward on medical-grade devices, and its chief executive predicts big strides in mhealth wearables will take root in the next decade. 20 Medicalgrade devices could certainly be the next generation of wearables. 21 FDA will certainly tighten its regulatory enforcement and already is looking to hire three senior health scientists to concentrate on digital health 22 to review medical-grade wearables. Startups are more likely to receive venture capital money if they understand regulations and have planned for regulatory approval in their product lifecycle. 23 mhealth wearables will become more sophisticated and may soon enter medical-grade territory. Increasingly, such technologies will be implantable and will become sophisticated drug delivery systems. Patients will be continuously monitored and, when necessary, provided with medication. Regulation will be inevitable if mhealth wearables make this transition. The question is, what form will such regulation take, and who will take the lead in defining the pathways? Regulation always follows innovation, and in this early stage of development, manufacturers have the opportunity to help shape regulators opinions and ideas. If consumer class-action lawsuits fill up the news headlines or consumers lose faith in mhealth wearables credibility, both manufacturers and regulatory bodies will be pushed to a reactive position, which will inevitably be conservative. The most effective action for wearables manufacturers is to self-regulate and impose high quality standards voluntarily to stay one step ahead. Manufacturers are not the only ones planning to change their position; regulators are planning for active enforcements as well. For example, the

5 REGULATORY IMPACT ON THE FUTURE OF mhealth WEARABLES PAGE 5 REFERENCES 1. wareable50/best-wearable-tech about-the-law/ 4. com/2015/6/24/ /fdaregulation-health-trackers-wearablesfitbit 5. com/2015/1/16/ /the-fdaprobably-wont-regulate-your-fitnesstracker 6. GuidanceDocuments/UCM pdf?source=govdelivery&utm_ medium= &utm_ source=govdelivery 7. index.php/2015/02/smart-waysto-manage-health-need-smartregulation/ 8. blog_hyman_phelps/2015/01/low-riskgeneral-wellness-products-will-notbe-regulated-as-medical-devices.html 9. GuidanceDocuments/UCM pdf GuidanceDocuments/UCM pdf GuidanceDocuments/UCM pdf GuidanceDocuments/UCM pdf digital-health-regulations/ Transparency/Basics/ucm htm white-papers/mhealth-wearablesdata-usage-accuracy-and-futureadvancement.pdf ReportsManualsForms/Reports/ ucm htm reports/ edge-of-insight.pdf articles/new-regulation/fdaregulates-electric-toothbrushes-asmedical-devices/ the-fitbit-of-the-future-won-t-justtrack-your-steps-it-ll-save-your-life#. om9hcrilk com/story/fitbit-shifts-high-gearmhealth-device-strategy/ jenniferhicks/2016/04/30/ are-medical-grade-devicesthe-next-generation-ofwearables/#5002e com/healthcare-informationtechnology/fda-to-hire-healthscientists-to-review-medical-gradewearables.html digital-health-funding-2015-year-inreview/

6 REGULATORY IMPACT ON THE FUTURE OF mhealth WEARABLES PAGE 6 ABOUT THE AUTHOR JESSICA SANTOS, PH.D. Dr. Jessica Santos is the Global Compliance and Quality Director at Kantar Health, the largest custom market research company focused on the life sciences industry. She is primarily responsible for providing oversight and support across the 40+ Kantar Health global offices in the areas of regulation, interaction with clients, suppliers and others within Kantar Health, Kantar and WPP. Dr. Santos is responsible for maintaining, anticipating and coordinating all activities with regard to compliance laws/regulations, industry guidelines, pharmacovigilance and client contracts, defining and driving the execution of Kantar Health s Quality Strategy our approach to measuring and improving our quality efforts. Dr. Santos is an experienced statistician, analyst, methodologist and market research scientist. She gained her reputation through her publications and professional committee work in the industry. She is a frequent speaker and contributor in major conferences and has a Ph.D. in Marketing, an MRS fellowship and Chartered Marketer status. Dr. Santos is a member of UK Research Ethics Committee, EphMRA, BHBIA and PMRG Government Affairs Committee, reviewer and co-chair of ISPOR, and MRS Professional Development Advisory Board and Examiner. FOR MORE INFORMATION Please contact info@kantarhealth.com, or visit us at WHY KANTAR HEALTH? Kantar Health is a leading global healthcare consulting firm and trusted advisor to many of the world s leading pharmaceutical, biotech and medical device and diagnostic companies. It combines evidence-based research capabilities with deep scientific, therapeutic and clinical knowledge, commercial development know-how, and brand and marketing expertise to help clients evaluate opportunities, launch products and maintain brand and market leadership. Our advisory services span three areas critical to bringing new medicines and pharmaceutical products to market commercial development, clinical strategies and marketing effectiveness.