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Study finds Germany trails Spain and the US in digital health

pharmaphorum

All three nations said the introduction of digital medical records, the expansion of telemedicine services and the use of patient data for diagnosis are desirable outcomes of a digital health revolution, while around a third of people in each country are also in favour of greater use of wearable devices to harvest health data.

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Can Hepatitis C drugs reduce symptoms of PTSD?

European Pharmaceutical Review

A study led by Boston University School of Public Health (BUSPH) and the White River Junction Veterans Affairs Medical Center in Vermont has completed a rigorous analysis to compare the effectiveness of direct acting antivirals on improving symptoms of posttraumatic stress disorder (PTSD). .

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2021 market access prospects for Germany

pharmaphorum

IQWiG sees far less promise in other RWE sources such as electronic medical records and billing records of insurers. Figure 1: AMNOG procedures and findings, 2011-2019. Leela worked as an advisor to the Department of Health and Social Care on the 2019 Voluntary Scheme for Branded Medicines Pricing and Access (VPAS).

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When Worlds Collide: The Theory of Real-World Evidence Meets Reality

The FDA Law Blog

Based on a review of premarket submissions made in 2012 through 2019, FDA identified 90 examples of 510(k)s, De Novos, HDEs, and PMAs approved/cleared which utilized RWE in support of regulatory decision-making. Every use of ESD is recorded, as is every behavior that falls within the intended use.

FDA 111
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How to get insurance to cover Ozempic for weight loss

The Checkup by Singlecare

If your insurance provider requires prior authorization for Ozempic, make sure your healthcare provider has all your relevant medical history to request authorization. This might include medical records for past treatments, lifestyle changes, and comorbid conditions related to your medical condition.

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Long-Awaited Guidance on FDAMA 115: Confirmatory Evidence Finally Has Its Moment (to be Crossed Off the FDA’s Guidance To-Do List)

The FDA Law Blog

However, the two previous FDA guidance documents, released in May 1998 ( Providing Clinical Evidence of Effectiveness for Human Drug and Biological Products , available here ) and December 2019 ( Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products , available here ), differ from the new guidance.

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Deep 6 AI: the smart software breathing new life into clinical trials

pharmaphorum

As a result, trawling through a physician’s notes in electronic medical records (EMRs), pathology reports, and other medical data to determine the most important insights could take human beings months. In 2019, the company received $17 million in fresh funding in the company’s Series A.