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  • Regulatory NewsRegulatory News

    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...
  • Regulatory NewsRegulatory News

    CDRH Classifies Software App for Contraception into Class II

    Following the 2018 US Food and Drug Administration (FDA) approval of the country’s first mobile medical application indicated for contraceptive use, the agency issued a final order Tuesday to classify the software app for contraception as a class II device. The regulation set forth in the final order comes as a result of the 2017 de novo classification request FDA’s Center for Devices and Radiological Health (CDRH) granted  to Swedish startup company Natural Cycles Nor...
  • Feature ArticlesFeature Articles

    Wearable Technologies and Mobile Health Devices: Changing Medical Research and Delivering Better Patient Outcomes

    This article discusses how wearable technologies and mobile health devices are changing medical practice and improving patient outcomes with the potential to lower research and development costs and impact reimbursement. Introduction Wearable technologies and mobile Health (mHealth) devices are increasingly helping patients report meaningful outcomes and manage their conditions while enhancing their quality of life. Wearable technologies are "smart" electronic devices...
  • Regulatory NewsRegulatory News

    Apple Continues Push Into Device Industry With New Patent Filing

    Last week, tech behemoth Apple signaled its interest in further pursuing the development of new medical devices with a new patent granted for an electronic device that "computes health data." According to the patent , the device computes health data based on sensors and electrical contacts with one or more body parts of the user. The device, comprised of a camera, an ambient light sensor, a proximity sensor and a processing unit communicably coupled to the camera...
  • Regulatory NewsRegulatory News

    FDA Declares ‘General Wellness’ Devices Exempt From Regulations

    The US Food and Drug Administration (FDA) on Thursday finalized guidance saying that it does not plan to review low-risk "general wellness products", such as wearable fitness monitors or sleep trackers and will not require them to comply with premarket and postmarket regulatory requirements. Under the guidance, such products are exempt as long as they "are intended for only general wellness use…and present a low risk to the safety of users and other persons." As in the...
  • Regulatory NewsRegulatory News

    Industry Calls for More Guidance From FDA on New Clinical Trials Technology

    The initiation of a new era of mobile health technology has erupted into industry calling on the US Food and Drug Administration (FDA) to offer more guidance on how best to use new technology, like Fitbits and mobile apps, in clinical trials, and to find ways that don’t restrict the development of novel tech products. In October 2015, FDA put out a request for more information on the types of technologies and innovations companies are employing to conduct clinical rese...
  • Regulatory NewsRegulatory News

    FDA Collaborates With FTC on Mobile Health App Regulatory Tool

    The US Food and Drug Administration (FDA), the Federal Trade Commission (FTC) and other regulators are looking to help health-related mobile application developers comply with the Federal Food, Drug and Cosmetics Act (FD&C Act) and other applicable laws. As part of that compliance push, FTC on Tuesday released  a new web-based tool for developers of health-related mobile apps .  The tool asks developers a series of high-level questions about the app’s function, the da...
  • Regulatory NewsRegulatory News

    EU Looks to Improve Data Quality of mHealth Apps

    The European Commission is bringing together a working group to develop guidelines by the end of 2016 for assessing the validity and reliability of the data that mobile health (mHealth) applications collect and process in order to make these ubiquitous apps more useful for public health. The working group comes as such lifestyle and well-being mHealth (everything from step trackers to heart rate analyzers to weight-loss helpers) has skyrocketed to more than 100,000 apps...