<?xml version="1.0" encoding="UTF-8"?>
<rss version="2.0" xmlns:media="http://search.yahoo.com/mrss/">
  <channel>
    <title>Cybersecurity</title>
    <description>
      <![CDATA[]]>
    </description>
    <link>https://www.bioworld.com/rss</link>
    <language>en-us</language>
    <item>
      <title>US cybersecurity rule may increase device reporting requirements</title>
      <description>
        <![CDATA[Makers of medical devices already have a substantial series of requirements related to cybersecurity, but those requirements may increase per a draft rule released by the U.S. Cybersecurity and Infrastructure Security Agency.]]>
      </description>
      <guid>http://www.bioworld.com/articles/706914</guid>
      <pubDate>Wed, 03 Apr 2024 12:00:00 -0400</pubDate>
      <link>https://www.bioworld.com/articles/706914-us-cybersecurity-rule-may-increase-device-reporting-requirements</link>
      <media:content url="https://www.bioworld.com/ext/resources/Stock-images/Misc/Cyber-security-padlock.webp?t=1775847161" type="image/jpeg" medium="image" fileSize="410931">
        <media:title type="plain">Cyber security padlock</media:title>
      </media:content>
    </item>
    <item>
      <title>Henry Schein bones up orthopedic commitment</title>
      <description>
        <![CDATA[Henry Schein Inc., long known primarily as a dental equipment distributor, added two deals to its 2023 roster that will expand its presence in the orthopedics market. The company agreed to acquire a majority interest in Trimed Inc., which focuses on solutions for treatment of the upper and lower extremities and entered into a strategic relationship with Extremity Medical LLC.]]>
      </description>
      <guid>http://www.bioworld.com/articles/703757</guid>
      <pubDate>Wed, 20 Dec 2023 11:00:00 -0500</pubDate>
      <link>https://www.bioworld.com/articles/703757-henry-schein-bones-up-orthopedic-commitment</link>
      <media:content url="https://www.bioworld.com/ext/resources/Stock-images/Deals-and-MAs/Acquisition-puzzle.webp?t=1682968589" type="image/jpeg" medium="image" fileSize="193595">
        <media:title type="plain">Acquisition puzzle</media:title>
      </media:content>
    </item>
    <item>
      <title>US FTC hits gene testing firm for claims related to ancestry testing</title>
      <description>
        <![CDATA[The U.S. Federal Trade Commission announced Nov. 21 that it has obtained a civil monetary penalty in the amount of $700,000 from CRI Genetics LLC, an enforcement action taken under the agency’s policy for biometrics information.]]>
      </description>
      <guid>http://www.bioworld.com/articles/702901</guid>
      <pubDate>Wed, 22 Nov 2023 11:00:00 -0500</pubDate>
      <link>https://www.bioworld.com/articles/702901-us-ftc-hits-gene-testing-firm-for-claims-related-to-ancestry-testing</link>
    </item>
    <item>
      <title>US applying more pressure to med-tech industry around cybersecurity</title>
      <description>
        <![CDATA[The medical device industry might at times believe that it is the sole focus of the U.S. federal government thinking about cybersecurity, but the FDA is hardly alone in leaning hard on industry to stand up a solid cybersecurity regime. The Securities and Exchange Commission (SEC) is also turning the screws on corporate America regarding cybersecurity as seen in enforcement against Solarwinds Corp., an enforcement action that Seth Carmody of Medcrypt Inc., said highlights the breadth of regulatory hazards for the med-tech industry.]]>
      </description>
      <guid>http://www.bioworld.com/articles/702707</guid>
      <pubDate>Fri, 17 Nov 2023 11:00:00 -0500</pubDate>
      <link>https://www.bioworld.com/articles/702707-us-applying-more-pressure-to-med-tech-industry-around-cybersecurity</link>
    </item>
    <item>
      <title>FDA says hospital IT systems may be hostile cybersecurity environments</title>
      <description>
        <![CDATA[As reported ipreviously in coverage by BioWorld, the U.S. FDA’s latest guidance on cybersecurity elevates the agency’s demands for medical device cybersecurity, but the agency advised industry in a recent webinar that hospital IT systems are fraught with cybersecurity hazards of their own, and thus device makers should view these IT systems as potentially hostile environments where cybersecurity is concerned.]]>
      </description>
      <guid>http://www.bioworld.com/articles/702473</guid>
      <pubDate>Wed, 08 Nov 2023 11:00:00 -0500</pubDate>
      <link>https://www.bioworld.com/articles/702473-fda-says-hospital-it-systems-may-be-hostile-cybersecurity-environments</link>
      <media:content url="https://www.bioworld.com/ext/resources/Stock-images/Devices/cybersecurity-data-lock.webp?t=1588286982" type="image/png" medium="image" fileSize="321597">
        <media:title type="plain">Cybersecurity data lock</media:title>
      </media:content>
    </item>
    <item>
      <title>FDA’s premarket cybersecurity guidance encodes legislative imperatives</title>
      <description>
        <![CDATA[The Consolidated Appropriations Act of 2023 covered a lot of budget terrain for the U.S. federal government, but Section 3305 was unusual for this type of bill in that it called on the FDA to require cybersecurity features as a part of the Quality System Regulation (QSR).]]>
      </description>
      <guid>http://www.bioworld.com/articles/701198</guid>
      <pubDate>Tue, 26 Sep 2023 12:00:00 -0400</pubDate>
      <link>https://www.bioworld.com/articles/701198-fdas-premarket-cybersecurity-guidance-encodes-legislative-imperatives</link>
    </item>
    <item>
      <title>US SEC cybersecurity rule narrows range of information disclosed, but holds four-day mandate</title>
      <description>
        <![CDATA[The U.S. Security and Exchange Commission’s final rule for disclosure of cybersecurity incidents would seem to weigh more heavily on device makers and their client hospitals than on other industries, particularly given that the draft rule required a four-day notification of any such events. The final rule retains that requirement to notify investors of any such breach within four days, although the SEC relented on the content of such disclosures to ease concerns about the potential for disclosures to amplify the cybersecurity threat.]]>
      </description>
      <guid>http://www.bioworld.com/articles/699440</guid>
      <pubDate>Mon, 31 Jul 2023 12:00:00 -0400</pubDate>
      <link>https://www.bioworld.com/articles/699440-us-sec-cybersecurity-rule-narrows-range-of-information-disclosed-but-holds-four-day-mandate</link>
    </item>
    <item>
      <title>SEC: Cybersecurity incidents to be disclosed on 8-Ks</title>
      <description>
        <![CDATA[Public companies registered with the U.S. SEC will soon have to disclose material cybersecurity incidents and annually report material information regarding their cybersecurity risk management, strategy and governance.]]>
      </description>
      <guid>http://www.bioworld.com/articles/699435</guid>
      <pubDate>Thu, 27 Jul 2023 12:00:00 -0400</pubDate>
      <link>https://www.bioworld.com/articles/699435-sec-cybersecurity-incidents-to-be-disclosed-on-8-ks</link>
    </item>
    <item>
      <title>SEC: Cybersecurity incidents to be disclosed on 8-Ks</title>
      <description>
        <![CDATA[Public companies registered with the U.S. SEC will soon have to disclose material cybersecurity incidents and annually report material information regarding their cybersecurity risk management, strategy and governance.]]>
      </description>
      <guid>http://www.bioworld.com/articles/699407</guid>
      <pubDate>Wed, 26 Jul 2023 12:00:00 -0400</pubDate>
      <link>https://www.bioworld.com/articles/699407-sec-cybersecurity-incidents-to-be-disclosed-on-8-ks</link>
    </item>
    <item>
      <title>FDA inks refuse-to-accept final guidance for cybersecurity without comment period</title>
      <description>
        <![CDATA[The U.S. FDA has released a final guidance for the agency’s refuse-to-accept (RTA) policy for cybersecurity measures in medical devices, a policy document that was required by Congress via the Consolidated Appropriations Act for the 2023 federal fiscal budget. ]]>
      </description>
      <guid>http://www.bioworld.com/articles/695698</guid>
      <pubDate>Fri, 31 Mar 2023 13:00:00 -0400</pubDate>
      <link>https://www.bioworld.com/articles/695698-fda-inks-refuse-to-accept-final-guidance-for-cybersecurity-without-comment-period</link>
      <media:content url="https://www.bioworld.com/ext/resources/Stock-images/Regulatory/Regulatory-US-FDA-HQ.webp?t=1707859292" type="image/png" medium="image" fileSize="2264756">
        <media:title type="plain">U.S. FDA headquarters</media:title>
      </media:content>
    </item>
    <item>
      <title>MDMA blasts FDA cybersecurity draft for mention of health care facility networks</title>
      <description>
        <![CDATA[The U.S. FDA’s latest draft guidance for premarket cybersecurity considerations expands considerably on the previous edition, and suggests that the manufacturer’s cybersecurity responsibilities include security in a health care facility’s network.]]>
      </description>
      <guid>http://www.bioworld.com/articles/520752</guid>
      <pubDate>Fri, 15 Jul 2022 13:00:00 -0400</pubDate>
      <link>https://www.bioworld.com/articles/520752-mdma-blasts-fda-cybersecurity-draft-for-mention-of-health-care-facility-networks</link>
      <media:content url="https://www.bioworld.com/ext/resources/Stock-images/Devices/cybersecurity-data-lock.webp?t=1588286982" type="image/png" medium="image" fileSize="321597">
        <media:title type="plain">Cybersecurity data lock</media:title>
      </media:content>
    </item>
    <item>
      <title>MDMA blasts FDA cybersecurity draft for mention of health care facility networks</title>
      <description>
        <![CDATA[The U.S. FDA’s latest draft guidance for premarket cybersecurity considerations expands considerably on the previous edition, and suggests that the manufacturer’s cybersecurity responsibilities include security in a health care facility’s network.]]>
      </description>
      <guid>http://www.bioworld.com/articles/520721</guid>
      <pubDate>Thu, 14 Jul 2022 13:00:00 -0400</pubDate>
      <link>https://www.bioworld.com/articles/520721-mdma-blasts-fda-cybersecurity-draft-for-mention-of-health-care-facility-networks</link>
      <media:content url="https://www.bioworld.com/ext/resources/Stock-images/Devices/cybersecurity-data-lock.webp?t=1588286982" type="image/png" medium="image" fileSize="321597">
        <media:title type="plain">Cybersecurity data lock</media:title>
      </media:content>
    </item>
    <item>
      <title>IMDRF posts new draft guidance for cybersecurity</title>
      <description>
        <![CDATA[The International Medical Device Regulators Forum (IMDRF) has posted a draft guidance for cybersecurity practices for legacy devices, a nod to the number of older devices that are difficult to secure. This document is a follow-up to a standing IMDRF guidance that spans the product life cycle, but which apparently left stakeholders with a few questions.]]>
      </description>
      <guid>http://www.bioworld.com/articles/519435</guid>
      <pubDate>Fri, 03 Jun 2022 13:00:00 -0400</pubDate>
      <link>https://www.bioworld.com/articles/519435-imdrf-posts-new-draft-guidance-for-cybersecurity</link>
      <media:content url="https://www.bioworld.com/ext/resources/Stock-images/Geographic-regions/World-trade-illustration.webp?t=1620237523" type="image/png" medium="image" fileSize="263251">
        <media:title type="plain">World trade illustration</media:title>
      </media:content>
    </item>
    <item>
      <title>FDA strikes aggressive tone in new draft guidance for premarket cybersecurity</title>
      <description>
        <![CDATA[For the second time in four years, the FDA has issued a draft guidance for cybersecurity in premarket applications, just one of several actions undertaken recently by the U.S. federal government in connection with cybersecurity.]]>
      </description>
      <guid>http://www.bioworld.com/articles/517863</guid>
      <pubDate>Tue, 12 Apr 2022 13:00:00 -0400</pubDate>
      <link>https://www.bioworld.com/articles/517863-fda-strikes-aggressive-tone-in-new-draft-guidance-for-premarket-cybersecurity</link>
      <media:content url="https://www.bioworld.com/ext/resources/Stock-images/Regulatory/Laptop-displaying-FDA-logo.webp?t=1695241730" type="image/png" medium="image" fileSize="347445">
        <media:title type="plain">Laptop displaying FDA logo</media:title>
      </media:content>
    </item>
    <item>
      <title>Digital innovation highlighted as companies are called to ‘reimagine’ health </title>
      <description>
        <![CDATA[At this year’s Healthcare Information and Management Systems Society (HIMSS) 2022 conference in Orlando, Fla., digital health companies across the sector gathered to showcase new products and services. HIMSS CEO Hal Wolf urged the industry to focus on global health equity and a 2022 survey of health care leaders highlighted the elements of digital transformation that are causing the biggest buzz.]]>
      </description>
      <guid>http://www.bioworld.com/articles/517099</guid>
      <pubDate>Fri, 18 Mar 2022 13:00:00 -0400</pubDate>
      <link>https://www.bioworld.com/articles/517099-digital-innovation-highlighted-as-companies-are-called-to-reimagine-health</link>
      <media:content url="https://www.bioworld.com/ext/resources/Stock-images/AI/AI-technology-data.webp?t=1588275827" type="image/png" medium="image" fileSize="570038">
        <media:title type="plain">Health professional touching screen, digital/medical icons</media:title>
      </media:content>
    </item>
    <item>
      <title>FDA says PTC Axeda software vulnerabilities affect wide range of medical devices</title>
      <description>
        <![CDATA[The U.S. FDA has issued an advisory regarding vulnerabilities identified in the Axeda line of remote access software published by PTC Inc., which may affect more than 100 products made by dozens of manufacturers. The vulnerability could allow a hacker to trigger changes in the operation of the affected devices, a massive risk to patients undergoing medical imaging and radiotherapy procedures. The FDA notice stated that the Axeda Agent and desktop server programs are the subject of a notice by the Cybersecurity & Infrastructure Security Agency (CISA), which characterizes the vulnerability as requiring only a low-complexity attack to exploit.]]>
      </description>
      <guid>http://www.bioworld.com/articles/516845</guid>
      <pubDate>Thu, 10 Mar 2022 13:00:00 -0500</pubDate>
      <link>https://www.bioworld.com/articles/516845-fda-says-ptc-axeda-software-vulnerabilities-affect-wide-range-of-medical-devices</link>
      <media:content url="https://www.bioworld.com/ext/resources/Stock-images/Devices/cloud-cybersecurity.webp?t=1589385360" type="image/png" medium="image" fileSize="600903">
        <media:title type="plain">Cloud/cybersecurity illustration</media:title>
      </media:content>
    </item>
    <item>
      <title>Device makers leaning in to ensure equipment, supplies reach Ukraine </title>
      <description>
        <![CDATA[Though the Ukraine war has had an impact on the availability of medical devices and diagnostics, a number of companies based in the U.S. and Europe have announced measures to ensure their products will reach the war-torn nation. Device companies are donating millions to nongovernmental organizations for humanitarian assistance, while the Advanced Medical Technology Association (Advamed) said its member companies are tracking the situation and are eager to pitch in with desperately needed supplies and medical equipment.]]>
      </description>
      <guid>http://www.bioworld.com/articles/516766</guid>
      <pubDate>Tue, 08 Mar 2022 13:00:00 -0500</pubDate>
      <link>https://www.bioworld.com/articles/516766-device-makers-leaning-in-to-ensure-equipment-supplies-reach-ukraine</link>
      <media:content url="https://www.bioworld.com/ext/resources/Stock-images/Geographic-regions/Europe/Ukraine-aid-supplies.webp?t=1646779660" type="image/png" medium="image" fileSize="503743">
        <media:title type="plain">Pallet of boxes on top of map of Ukraine</media:title>
      </media:content>
    </item>
    <item>
      <title>Japan updates guidelines for cybersecurity, single-use devices and MDSAP</title>
      <description>
        <![CDATA[Japan’s Ministry of Health, Labor and Welfare (MHLW) released a number of new guidelines and clarifications on medical device regulatory issues including cybersecurity, remanufactured single-use devices (SUDs) and the Medical Device Single Audit Program (MDSAP).]]>
      </description>
      <guid>http://www.bioworld.com/articles/516406</guid>
      <pubDate>Thu, 24 Feb 2022 13:00:00 -0500</pubDate>
      <link>https://www.bioworld.com/articles/516406-japan-updates-guidelines-for-cybersecurity-single-use-devices-and-mdsap</link>
      <media:content url="https://www.bioworld.com/ext/resources/Stock-images/Geographic-regions/Asia/Japan-flag-digital-tech.webp?t=1683139530" type="image/jpeg" medium="image" fileSize="229696">
        <media:title type="plain">Digital 3-D illustration of Japan's flag, light effects</media:title>
      </media:content>
    </item>
    <item>
      <title>IV pumps top list of medical devices still vulnerable to cybersecurity threats</title>
      <description>
        <![CDATA[Cybersecurity challenges can represent an existential threat to patients on medical devices, and a new report by New York-based Cynerio Inc. highlights some of those challenges. One of the findings in the report is that nearly three-fourths of intravenous pumps, which make up 38% of a hospital’s internet of things (IoT) footprint, are vulnerable to an attack, a predicament that continues to put desperately ill patients in jeopardy.]]>
      </description>
      <guid>http://www.bioworld.com/articles/515406</guid>
      <pubDate>Mon, 24 Jan 2022 12:00:00 -0500</pubDate>
      <link>https://www.bioworld.com/articles/515406-iv-pumps-top-list-of-medical-devices-still-vulnerable-to-cybersecurity-threats</link>
      <media:content url="https://www.bioworld.com/ext/resources/Stock-images/Devices/cloud-cybersecurity.webp?t=1589385360" type="image/png" medium="image" fileSize="600903">
        <media:title type="plain">Cloud/cybersecurity illustration</media:title>
      </media:content>
    </item>
    <item>
      <title>DoJ creates program to ramp up False Claims Act litigation for cybersecurity lapses</title>
      <description>
        <![CDATA[The FDA has struggled to revise a guidance related to cybersecurity in medical devices, but developers now have more than just lagging FDA guidances to worry about where cybersecurity is concerned. The U.S. Department of Justice (DoJ) has unveiled a program designed to leverage the False Claims Act to pursue entities that come up short of regulatory expectations for cybersecurity, constituting a new vector for liability for makers of devices and medical software.]]>
      </description>
      <guid>http://www.bioworld.com/articles/512811</guid>
      <pubDate>Wed, 27 Oct 2021 13:00:00 -0400</pubDate>
      <link>https://www.bioworld.com/articles/512811-doj-creates-program-to-ramp-up-false-claims-act-litigation-for-cybersecurity-lapses</link>
      <media:content url="https://www.bioworld.com/ext/resources/Stock-images/Geographic-regions/US/US-law-flag-gavel.webp?t=1593467765" type="image/png" medium="image" fileSize="1749746">
        <media:title type="plain">Judge's gavel with US flag</media:title>
      </media:content>
    </item>
    <item>
      <title>U.S. lacks cyber oversight of hospitals’ networked medical devices</title>
      <description>
        <![CDATA[As cyberattacks on U.S. hospitals continue to increase with health care&rsquo;s growing reliance on technology, a new report from the U.S. Office of Inspector General (OIG) has flagged Medicare&rsquo;s requirements for being silent on the cybersecurity of networked medical devices. The OIG&rsquo;s study found hospitals are not required to identify networked device cybersecurity in their emergency preparedness risk assessments, and as a result, they don&rsquo;t include this information &ldquo;very often.&rdquo;]]>
      </description>
      <guid>http://www.bioworld.com/articles/508675</guid>
      <pubDate>Fri, 25 Jun 2021 13:00:00 -0400</pubDate>
      <link>https://www.bioworld.com/articles/508675-us-lacks-cyber-oversight-of-hospitals-networked-medical-devices</link>
      <media:content url="https://www.bioworld.com/ext/resources/Stock-images/Devices/cloud-cybersecurity.webp?t=1589385360" type="image/png" medium="image" fileSize="600903">
        <media:title type="plain">Cloud/cybersecurity illustration</media:title>
      </media:content>
    </item>
    <item>
      <title>FDA seeks input on cybersecurity issues in medical device servicing</title>
      <description>
        <![CDATA[A new FDA discussion paper addresses cybersecurity issues specific to the servicing of medical devices, with the goal of guiding the conversation about potential challenges and opportunities. It coincides with a larger agency initiative to provide more clarity on servicing.]]>
      </description>
      <guid>http://www.bioworld.com/articles/508432</guid>
      <pubDate>Fri, 18 Jun 2021 13:00:00 -0400</pubDate>
      <link>https://www.bioworld.com/articles/508432-fda-seeks-input-on-cybersecurity-issues-in-medical-device-servicing</link>
      <media:content url="https://www.bioworld.com/ext/resources/Stock-images/Devices/cybersecurity-data-lock.webp?t=1588286982" type="image/png" medium="image" fileSize="321597">
        <media:title type="plain">Cybersecurity data lock</media:title>
      </media:content>
    </item>
    <item>
      <title>FDA responds to NIST call on cybersecurity executive order</title>
      <description>
        <![CDATA[The FDA&rsquo;s Center for Devices and Radiological Health (CDRH) issued a new document on June 8 responding to the National Institute of Standards and Technology (NIST) call for position papers to fulfill the President&rsquo;s Executive Order on improving the federal government&rsquo;s cybersecurity. It details how CDRH is planning to do its part to advance the shared goal within medical devices.]]>
      </description>
      <guid>http://www.bioworld.com/articles/508037</guid>
      <pubDate>Wed, 09 Jun 2021 13:00:00 -0400</pubDate>
      <link>https://www.bioworld.com/articles/508037-fda-responds-to-nist-call-on-cybersecurity-executive-order</link>
      <media:content url="https://www.bioworld.com/ext/resources/Stock-images/Devices/digital-privacy-globe.webp?t=1601416325" type="image/png" medium="image" fileSize="866096">
        <media:title type="plain">Lock on digital globe illustration</media:title>
      </media:content>
    </item>
    <item>
      <title>Speaker makes case for bringing clinicians on board the cybersecurity train</title>
      <description>
        <![CDATA[It&rsquo;s no secret that physicians are the interface between device makers and the patient, but their role in cybersecurity has been limited to date. However, Christian Dameff, assistant professor of biomedical informatics and computer science at the University of California San Diego, said its time to engage physicians once they are in practice and to include cybersecurity in medical school education, two efforts he said would go a long way toward improving medical device cybersecurity in the clinical setting.]]>
      </description>
      <guid>http://www.bioworld.com/articles/507026</guid>
      <pubDate>Wed, 12 May 2021 13:00:00 -0400</pubDate>
      <link>https://www.bioworld.com/articles/507026-speaker-makes-case-for-bringing-clinicians-on-board-the-cybersecurity-train</link>
      <media:content url="https://www.bioworld.com/ext/resources/Stock-images/Devices/cybersecurity-data-lock.webp?t=1588286982" type="image/png" medium="image" fileSize="321597">
        <media:title type="plain">Cybersecurity data lock</media:title>
      </media:content>
    </item>
    <item>
      <title>Second California privacy law sets up dual enforcement entities</title>
      <description>
        <![CDATA[In a span of a mere two years, the state of California passed two ballot initiatives dealing with privacy that promise to have an impact on digital health, the second of which created an office specifically for privacy enforcement matters. Eric Goldman, a professor of law at the Santa Clara (California) University School of Law, said on a recent webinar that the state attorney general&rsquo;s office and the new California Privacy Protection Agency (CPPA) have overlapping jurisdiction, and as a consequence, companies doing business in California may find themselves at the mercy of not one, but two enforcement entities.]]>
      </description>
      <guid>http://www.bioworld.com/articles/504562</guid>
      <pubDate>Tue, 09 Mar 2021 13:00:00 -0500</pubDate>
      <link>https://www.bioworld.com/articles/504562-second-california-privacy-law-sets-up-dual-enforcement-entities</link>
      <media:content url="https://www.bioworld.com/ext/resources/Stock-images/Devices/digital-privacy-globe.webp?t=1601416325" type="image/png" medium="image" fileSize="866096">
        <media:title type="plain">Lock on digital globe illustration</media:title>
      </media:content>
    </item>
    <item>
      <title>Vulnerability found in GE Healthcare devices </title>
      <description>
        <![CDATA[The latest global regulatory news, changes and updates affecting medical devices and technologies, including: FDA: Metal-containing masks can cause injuries during MRIs.]]>
      </description>
      <guid>http://www.bioworld.com/articles/501087</guid>
      <pubDate>Tue, 08 Dec 2020 12:00:00 -0500</pubDate>
      <link>https://www.bioworld.com/articles/501087-vulnerability-found-in-ge-healthcare-devices</link>
    </item>
    <item>
      <title>FDA looks to provide additional technical information related to 2016 EMC guidance</title>
      <description>
        <![CDATA[The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Vaccine, diagnostic developers targeted by cyberattacks; Groups make case for extending sequester moratorium; More money needed for global vaccine effort; Russia extends COVID-19 drug, device program.]]>
      </description>
      <guid>http://www.bioworld.com/articles/500252</guid>
      <pubDate>Mon, 16 Nov 2020 12:00:00 -0500</pubDate>
      <link>https://www.bioworld.com/articles/500252-fda-looks-to-provide-additional-technical-information-related-to-2016-emc-guidance</link>
    </item>
    <item>
      <title>FDA adds to roster of regulatory science tools</title>
      <description>
        <![CDATA[The latest global regulatory news, changes and updates affecting medical devices and technologies, including: NIST ramps up Zero Trust cybersecurity program; TGA sets date for mesh up-classification; IMDRF posts post-market study update; ANVISA updates list of non-regulated devices.]]>
      </description>
      <guid>http://www.bioworld.com/articles/499217</guid>
      <pubDate>Tue, 20 Oct 2020 12:00:00 -0400</pubDate>
      <link>https://www.bioworld.com/articles/499217-fda-adds-to-roster-of-reg-science-tools</link>
    </item>
    <item>
      <title>CMS’s new NCD waitlist includes Cardiomems</title>
      <description>
        <![CDATA[The latest global regulatory news, changes and updates affecting medical devices and technologies, including: FDA’s cybersecurity discussion paper emerges; CMS eyes MAC default for Allomap coverage; CMS floats draft coverage for CRC screening test.]]>
      </description>
      <guid>http://www.bioworld.com/articles/499142</guid>
      <pubDate>Mon, 19 Oct 2020 12:00:00 -0400</pubDate>
      <link>https://www.bioworld.com/articles/499142-cmss-new-ncd-waitlist-includes-cardiomems</link>
    </item>
    <item>
      <title>FDA eyes 2021 for reissue of Oct. 2018 premarket cybersecurity draft guidance</title>
      <description>
        <![CDATA[There are some U.S. FDA work items that have been hampered primarily by the COVID-19 pandemic, and some that have just proven difficult to push across the finish line. The FDA&rsquo;s October 2018 draft guidance for premarket considerations for cybersecurity in medical devices might fall into that latter category, but the FDA&rsquo;s Suzanne Schwartz said the agency will reissue another draft version of that guidance, which will be available sometime in early 2021.]]>
      </description>
      <guid>http://www.bioworld.com/articles/498751</guid>
      <pubDate>Thu, 08 Oct 2020 13:00:00 -0400</pubDate>
      <link>https://www.bioworld.com/articles/498751-fda-eyes-2021-for-reissue-of-oct-2018-premarket-cybersecurity-draft-guidance</link>
      <media:content url="https://www.bioworld.com/ext/resources/Stock-images/Devices/cybersecurity-data-lock.webp?t=1588286982" type="image/png" medium="image" fileSize="321597">
        <media:title type="plain">Cybersecurity data lock</media:title>
      </media:content>
    </item>
  </channel>
</rss>
