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How a Biden Administration Will Affect FDA s Regulation of Medical Devices | Morgan Lewis

To embed, copy and paste the code into your website or blog: Medical device companies should be prepared for an increase in FDA enforcement activity with the incoming Biden administration, in addition to changes in agency leadership and repeals of regulatory reform. As President-elect Joseph Biden gears up to take office on January 20, the upcoming change in administration will impact the US Food and Drug Administration’s (FDA’s) oversight and regulation of medical devices and digital health. The most immediate and significant changes impacting FDA’s medical device oversight are likely to include a repeal of certain Trump administration orders on regulatory reform and changes in leadership at both FDA and the US Department of Health and Human Services (HHS). Certain FDA priorities, however, including efforts to prioritize COVID-19-related medical devices and digital health technologies, are expected to continue under the new administration. Device companies should be prepared

Gov t Takes Steps Toward Better EHR Interoperability

This story was originally published on March 9, 2020. As part of MedPage Today s review of the past year s top stories, we are republishing it, along with an update examining subsequent developments related to policies on electronic health records in 2020. WASHINGTON The Trump administration today issued two final rules related to interoperability of healthcare records, with administration officials noting that making patient health records portable and accessible is especially critical during incidents such as the COVID-19 outbreak. At a time when the healthcare system could be under stress with the handling of the COVID virus, the urgent need for coordinated, integrated care could not be clearer, Seema Verma, administrator of the Centers for Medicare & Medicaid Services (CMS) said on a phone call with reporters. In a healthcare system characterized by the easy and seamless flow of information, one in which a patient s own data follows them to the provider they choose, ca

Some Healthcare Interoperability Rules Delayed Due to COVID

In March, MedPage Today published a story outlining two new interoperability rules issued by the Office of the National Coordinator (ONC) for Health Information Technology and the Centers for Medicare & Medicaid Services. Below we report on what has happened since. In March, the Trump administration issued two final rules related to interoperability of healthcare records, with administration officials noting that making patient health records portable and accessible is especially critical during incidents such as the COVID-19 outbreak. And yet, the outbreak itself has delayed implementation of some of those same rules. ONC issued a rule implementing the clinical interoperability provisions of the 21st Century Cures Act dealing with electronic health records (EHR), ONC head Don Rucker explained on a March 9 phone call with reporters. Our rule requires hospitals and doctors to provide software access points endpoints, if you will to their [EHR] databases so that patients ca

Health plans embrace technology during the pandemic: a roundup of payer news 2020

Share Through all of this year’s tumultuous ups and downs, one trend that has remained unstoppable – and has even accelerated – is the healthcare sector’s adoption of technology. MobiHealthNews has covered the payer space as it continually pushes further into the world of digital health, and 2020 proved no different. From traditional insurers embracing technology to massive expansions of telehealth, to innovative insurtech companies hitting the public market, this roundup goes deep into how payers are turning towards tech amid a changing world. Read on for a recap of payer digital health news from 2020. Insurers upping their technology game As much of this year was spent navigating different stay-at-home and social distancing mandates, many turned towards technology as a way to receive healthcare. As a result, even the most traditional healthcare insurers upped their tech-game this year.

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