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

by Marilou Winkler (2018-07-07)


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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.

Benzocaine is found in popular brands used to treat mouth sores in adults, including Orajel and Anbesol. The agency said it will take action against companies that don't voluntarily remove their products for young children. It is also asking for new warnings on adult products.

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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.

CERNER, VA OVERCOME HURDLES TO FINALIZE $10 BILLION CONTRACT:
Cerner and the Veterans Affairs (VA) completed a yearlong negotiating process, agreeing on a 10-year, $10 billion contract for Cerner to overhaul the VA's electronic health records (EHR) system, according
to Health Data Management. The deal had been delayed for months due to controversy regarding leadership turnover at the VA and criticism of Cerner's pilot rollout at four Department of Defense (DoD) sites, according
to Nextgov. The contract will give Cerner, which had underwhelming Q1 earnings it attributed largely to the delayed VA deal, access to a substantial market — it'll handle patient-data sharing between the VA and DoD, which have 20 million members. Lastly, the new customer volume gives Cerner additional leverage to dictate data storage and sharing standards. It's been an active May 2018 for Cerner; the company also announced plans
to unify the EHR systems of a Georgia-based health system and secured a deal
with state-run hospitals in Indiana.

Welcome to Digital Health Briefing, the newsletter providing the latest news, data, and insight on how digital technology is disrupting the healthcare ecosystem, produced by Business Insider Intelligence.

ALGORITHM TRANSFORMS GENOMICS INTO IMPROVED CLINICAL SUPPORT TOOL:
Researchers from Johns Hopkins University (JHU) developed an algorithm that converts complex genetic test data into a clinical decision support tool for oncologists, according
to Healthcare IT News. Although genomic data has the potential to vastly improve patient tattoo Tatuaje capilar Marbella Marbella diagnoses and treatment, most physicians aren't confident in their ability to interpret the complex output from genetic tests. Just 14% of providers would be comfortable interpreting genetic tests, according
to Clinical Innovation+Technology. The algorithm from JHU researchers can parse data on thousands of molecular states and converts it into a simplified readout that shows whether a patient's genetic markers are in a healthy range. If providers can evaluate genetic markers the same way they evaluate a patient's cholesterol level, friction in provider adoption is less likely as genetic testing pigmentación capilar en Marbella expands further into clinical settings. The growing precision medicine market is set to reach pigmentación dermopigmentación capilar en Marbella Marbella $88.6 billion, up from $39 billion in 2015, according
 to Market Research Future. Health systems will need clinical decision support tools that enable their team to unpack the full treatment potential of genomics.

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 pigmentación capilar en Marbella tools that have multiple functions, and describe how and when the FDA intends to look at non-regulated functions and services.

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