DIGITAL HEALTH BRIEFING: FDA aims to expand digital health oversight - Fitbit, Google partner for health - American Well will buy Avizia

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FDA EXPANDS OVERSIGHT FOR AI, DIGITAL THERAPEUTICS IN HEALTHCARE: In an effort to catch up with rapid digital innovation in the healthcare industry, the US Food and Drug Administration (FDA) is expanding its pre-certification program and establishing a new incubator for digital health technology. The FDA introduced the pre-certification program in 2017 to streamline the regulatory process of bringing digital health products to market.

The expansion dovetails with the FDA's efforts to increase its control over new digital health products. While it will help to accelerate the introduction and marketing of innovative products, it will also give the FDA oversight of software solutions that historically sit outside of its authority, FDA regulation expert Bradley Merrill Thompson told POLITICO. It could also pave the way for the agency to gather more insight into these companies' records and processes - a potential requirement for the precertification process.

The FDA's announcement addresses three areas that will impact the future of healthcare in the US and aims to ensure the regulatory oversight of the digitization of care delivery.

• Expanding the purview of the pre-certification for medtech. Many new and existing health products have multiple functions, some that are covered by the FDA's oversight, and some that aren't. The agency is putting draft provisions in place that will address the gap in tools that have multiple functions, and describe how and when the FDA intends to look at non-regulated functions and services.
• Encouraging and preparing for the development of health products and services that incorporate artificial intelligence (AI). AI is increasingly being incorporated into new health tools and products. The FDA is working to facilitate the inclusion of AI in digital health tools by looking into how it can apply its pre-certification program for tools based on AI.
• Exploring how digital health tools and services could be better integrated with prescription drugs. The use of data and smartphone apps to complement prescription medication, known as digital therapeutics, is a fast-growing segment of health. The FDA is investigating how to best include these offerings in the pre-certification program with the goal of adding the framework by the end of 2018. The agency also launched the Information Exchange and Data Transformation (INFORMED) incubator that will focus on tools to improve cancer treatment and drug development.

FITBIT TO USE GOOGLE'S HEALTHCARE CLOUD OFFERING: Wearables maker Fitbit announced Monday that it will be using Google's Cloud Healthcare API to make it easier for the doctors to access wearable data. Google introduced its dedicated healthcare cloud offering during the HIMSS 2018 conference in March. The product aims to facilitate health data interoperability by automating the process of collecting and storing patient data and then making it easier for physicians to pull actionable insights gleaned through machine learning algorithms. For Fitbit, the move will be a step forward in its efforts to become further entrenched in healthcare delivery. The company has been looking to the health industry to help generate revenue as shipments of its fitness trackers falter. Fitbit's troves of health data are also becoming increasingly valuable to payers, research institutions, and hospital networks, looking to glean consumer health insights. Lastly, although device shipments fell YoY, Fitbit's community of active users rose 9% YoY during Q4 2017, from 23 million to more than 25 million users. This is the second cloud health deal Fitbit has made this year, following its acquisition of Twine Health in February. Twine's HIPAA-compliant platform connects consumers diagnosed with chronic illnesses, like diabetes and hypertension, with doctors and coaches. These healthcare professionals can develop lifestyle strategies and programs to help patients monitor and manage their illnesses. The addition of Google's Cloud Healthcare API and its machine learning processes will make Fitbit's health data that much more valuable to researchers, physicians, and insurers looking to leverage insights to improve healthcare delivery and accelerate precision medicine offerings.

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AMERICAN WELL ACQUIRES AVIZIA, MOVING INTO HOSPITAL-BASED TELEMEDICINE: US telehealth provider, American Well is buying acute care telehealth provider Avizia, the company announced during the American Telemedicine Association 2018 (ATA2018) conference in Chicago. American Well's existing platform connects patients with doctors from a home setting. The acquisition will provide American Well with an acute care platform, allowing clients to access doctors and specialists from around the world within hospitals, meaning the service will be able to support more urgent care cases. The announcement comes as American Well accelerates its efforts to broaden the reach of its telehealth services. In January, the company partnered with Philips to embed its solutions with Philips digital health products. And during its January funding round, American Well received more than $59 million from insurer Allianz to build its telehealth platform. The company also partnered with Apple and Stanford Medicine to power the Apple Heart Study. Telemedicine services have grown rapidly over the past few years as health systems look to tech to boost hospital efficiency and drive customer growth and retention. In 2017, around 75% of US health systems either already were, or intended to implement a telehealth offering, according to a survey by Foley & Lardner. That's a significant shift in sentiment compared to findings in the first survey in 2014 when 87% of respondents said that patients wouldn't want virtual care services in 2017. As acquisitions and expansion efforts increase, we expect 2018 to be the tipping point for telehealth in the US - by 2023 telehealth offerings will be used by around 57% of the US population, representing an annualized growth rate of 75% over the next five years.

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SMARTPHONE-BASED GP AT HAND IS PLANNING EXPANSION: Just months after launching in Fulham, UK, GP at Hand, a smartphone solution that allows patients to consult with their general practitioner (GP) via a video link, is planning to expand to two more areas by end of year, according to Digital Health. Early adoption of the offering has been strong, and the 24-hour service could eventually provide more than 3 million patients across the greater London area access to a video consultation within two hours after a user inputs their symptoms. Virtual consultations are on track to become a much larger part of the healthcare system in the UK, not only because they appear to be popular with patients - in Fulham, where GP at Hand was trialed, 90% of patients gave the service a five star rating, according to the Daily Mail - but also because major resources are going into building out the digital health capability. For example, in October the National Health Service (NHS) launched a £45 million ($59 million) fund that will be used to launch digital consultation services.