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    WHO Releases First Guideline on Digital Health Interventions

    The World Health Organization (WHO) on Wednesday released a first-of-its-kind guideline on 10 ways for countries to apply digital health interventions across the health system while avoiding potential detrimental effects. The 10 recommendations are detailed in the UN agency’s 124-page guideline for strengthening health systems through the appropriate implementation of digital health. The focus of the guideline is currently limited to digital health technologies that can...
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    Health Canada Opens Generic Drug Guidances for Consultation

    Health Canada last week released two draft guidances for public consultation as part of the agency’s effort to clarify the criteria for its abbreviated new drug submission (ANDS) pathway for generic drugs.   Specifically, the draft guidances detail how the agency intends to implement a recently proposed regulatory amendment aimed at boosting access to generic drugs and making labeling more consistent and transparent.   “The draft guidance documents have been releas...
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    WHO Drafts Global Strategy on Digital Health

    The World Health Organization (WHO) released a newly drafted four-year global strategy on digital health, with an aim to “improve health for everyone, everywhere by accelerating the adoption of appropriate digital health.” As more health care delivery systems look to digital health to address emerging challenges, such as the rise of noncommunicable diseases, clinician workforce shortages and the aging population, barriers to the adoption and application of such tools pe...
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    FDA Proposes Regulatory Framework for AI- and Machine Learning-Driven SaMD

    The US Food and Drug Administration (FDA) requested feedback Tuesday on a new discussion paper that proposes applying a “focused review” approach to premarket assessments of software as a medical device (SaMD) technologies that are powered by artificial intelligence (AI) and machine learning (ML). The agency said it may conduct a “focused review” in cases where proposed SaMD pre-specifications (SPS) and algorithm change protocols (ACP) “can be refined based on the real-...
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    Industry Seeks Cross-Center Alignment in FDA Proposal on Prescription Drug Software

    The US Food and Drug Administration’s (FDA) regulation of prescription drug-use-related software (PDURS) behooves alignment across relevant centers, industry comments on FDA’s proposed framework argued. From pharmaceutical companies and trade associations to digital health companies and coalitions, the agency’s November 2018 proposed framework for the future regulation of PDURS drew comments from a range of stakeholders. The proposed framework  on PDURS is largely seen...
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    AdvaMed Responds to Senator’s Call to Advance Cybersecurity

    Responding to a letter from Sen. Mark Warner (D-VA) that called for a collaborative effort to advance cybersecurity in health care, medical device industry group AdvaMed sought to ease concerns about the impact of cyber attacks with updates on industry and regulators’ moves in line with its five principles. The industry trade association’s board of directors adopted the set of five medical device cybersecurity principles in 2017 to drive best practices across its member...
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    WHO Panel Calls for Global Gene Editing Registry

    The World Health Organization’s (WHO) newly-formed advisory panel on human genome editing is calling for the creation of a central registry for all human genome editing studies following a two-day meeting that concluded in Geneva on Tuesday.   WHO established the panel in December following reports that Chinese scientist He Jiankui had modified the genomes of a pair of twin girls to make them resistant to HIV infection. Jiankui’s claims prompted swift international b...
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    HHS Floats Digital Health PreCert Approach as CDRH Limits Pilot Participation

    In a proposed rule from the US Department of Health and Human Services (HHS), the agency is seeking input on whether to expand on the US Food and Drug Administration’s (FDA) digital health pre-certification (PreCert) program for purposes of health IT certification. Yet FDA has said it will limit PreCert participation, for now. The 724-page proposed rule was unveiled on Monday by HHS’s Office of the National Coordinator for Health Information Technology (ONC). The move h...
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    Health Canada Seeks to Better Define Regulatory Requirements for SaMD

    Health Canada released a draft guidance document on Tuesday to aid industry in determining whether the agency intends to regulate a software product as software as a medical device (SaMD). Health Canada notified industry last year of its intent to release draft guidance on SaMD as part of a larger initiative to improve regulatory reviews. The timeline, however, was delayed after a Health Canada scientific advisory panel raised concerns over the previous approach, whic...
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    Cybersecurity: FDA, Industry Groups Welcome Joint Plan

    The Healthcare and Public Health Sector Coordinating Council (HSCC) released a new medical device and health IT joint security plan (JSP) Monday to serve as a reference guide for strengthened cybersecurity. Industry-driven public-private partnership HSCC developed the new JSP in response to 2017 recommendations from the Health Care Industry Cybersecurity Task Force. It specifically addresses the second imperative identified by the task force—increase the security and re...
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    EMA, Health Canada to Tighten Alliance Around Mutual GMP Inspections

    Though the European Medicines Agency (EMA) and Canada have had a mutual recognition agreement (MRA) in operation since February 2003, both sides announced Monday that they may further strengthen their ties. On Friday, the European Commission’s DG Sante, EMA and Health Canada held the first Joint Sectoral Group (JSG) on Pharmaceuticals, which is a specialized committee established under the Committee on Trade in Goods of the Comprehensive Economic and Trade Agreement (CE...
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    Half of Clinical Trials Fail to Publish Results, UK Report Finds

    Despite UK and EU rules aimed at boosting clinical trials reporting and transparency, a new report by the UK House of Commons’ Science and Technology Committee finds that nearly half of clinical trials fail to publish results.   “Around half of clinical trials are currently left unreported, clinical trial registration is not yet universal in the UK and reported outcomes do not always align with the original study proposal,” the report finds.   Based on these findin...