The year to come in life sciences safety and regulatory practices

How 2020 has shaped the future of healthcare

The fruitful endeavors of the life sciences industry are impossible to miss. The year 2021 begins with two Covid-19 vaccines developed, tested and approved for use in just under a year along with multiple treatments, diagnostics and other medical technology.

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HHS issues HIPAA, CMS regulatory waivers to Texas hospitals

HHS issues HIPAA, CMS regulatory waivers to Texas hospitals

The Department of Health and Human Services has issued several waivers for Texas hospitals reeling from the devastating winter storm that has gripped the state. These waivers provide flexibility in complying with HIPAA rules and other federal regulations. Texans are

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HHS finalizes regulatory review rule, though more lenient than proposed

CMS expands Medicare emergency telehealth coverage with 11 new services

Dive Brief: The Trump administration on Friday finalized a rule requiring HHS to review existing regulations, with some exceptions, every 10 years based on their real-world impact. If not reviewed and approved in time, old rules would automatically expire. When

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AstraZeneca and Sinopharm clear regulatory hurdles in a week of vaccine milestones.

AstraZeneca and Sinopharm clear regulatory hurdles in a week of vaccine milestones.

The world hit a few more pandemic milestones this week with the distribution of the coronavirus vaccines developed by Moderna and by Pfizer and BioNTech; the advancement of trials studying other experimental shots; and the approval or authorization of coronavirus

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RANK links thymic regulatory T cells to fetal loss and gestational diabetes in pregnancy

RANK links thymic regulatory T cells to fetal loss and gestational diabetes in pregnancy

1.Soma-Pillay, P., Nelson-Piercy, C., Tolppanen, H. & Mebazaa, A. Physiological changes in pregnancy. Cardiovasc. J. Afr. 27, 89–94 (2016).PubMed  PubMed Central  Article  Google Scholar  2.Arck, P. C. & Hecher, K. Fetomaternal immune cross-talk and its consequences for maternal and offspring’s

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Medtronic, GE, Philips embrace AI amid regulatory limbo around algorithms

Medtronic, GE, Philips embrace AI amid regulatory limbo around algorithms

GE Healthcare, Medtronic and Philips are among the big medtechs investing in artificial intelligence and machine learning, technologies they contend hold potential for better diagnosing, managing and treating a wide variety of diseases and health conditions. While medtechs are only

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DTx regulatory teams talk the power of research beyond ticking FDA’s boxes

DTx regulatory teams talk the power of research beyond ticking FDA's boxes

For digital therapeutics companies, the FDA has often been viewed as the gatekeeper to getting products to the patients. However, today the conversation around efficacy and research is branching beyond just what ticks the FDA boxes, into what kinds of

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Fitbit’s ECG app gets regulatory clearance in U.S. and European Union

Fitbit’s ECG app gets regulatory clearance in U.S. and European Union

Fitbit’s new electrocardiogram app has officially received regulatory clearance in the U.S. and European Union for its latest smartwatch, the Fitbit Sense, to monitor heart rhythm and detect atrial fibrillation. Now that the app has 510(k) clearance from the U.S.

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Building an interstate regulatory framework for telemedicine

Building an interstate regulatory framework for telemedicine

About the authors: Andrew Dudum is the CEO and founder of Hims & Hers, a consumer-facing digital health company offering telehealth services. Joel White is executive director of the Health Innovation Alliance, a coalition of health and technology leaders who support

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With many regulatory barriers clear, remaining roadblocks for digital therapeutics are cultural, logistical

With many regulatory barriers clear, remaining roadblocks for digital therapeutics are cultural, logistical

While some of the more obvious barriers to digital therapeutics adoption in Europe have come crashing down recently, adoption is still hampered by cultural momentum. That was the conclusion of a group of digital therapeutics stakeholders who presented at HIMSS

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