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STAT+: Truveta enlists health systems, drugmakers to launch ambitious new genomic database

STAT

The genetic data, cross-referenced with the patients’ de-identified medical records, will be available for purchase for researchers and life sciences companies. Pharmaceutical company Regeneron has invested $119.5 Pharmaceutical company Regeneron has invested $119.5 Continue to STAT+ to read the full story…

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Walmart deploys Epic medical records tech across its health centers, virtual care services

Fierce Healthcare

Walmart deploys Epic medical records tech across its health centers, virtual care services. Wed, 09/29/2021 - 12:53.

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Clover Health to integrate Assistant tool into athenahealth electronic medical record

Fierce Healthcare

Clover Health to integrate Assistant tool into athenahealth electronic medical record. Tue, 09/07/2021 - 14:26.

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2021 market access prospects for Germany

pharmaphorum

The market access landscape in Germany is particularly interesting in 2021, as a key component – AMNOG – is ten years old, and that milestone prompts reflections on what has worked well and what needs reform. IQWiG sees far less promise in other RWE sources such as electronic medical records and billing records of insurers.

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Opinion: Medical experts must step up if health justice is to enter the courtroom

STAT

Saadi Ghatan, a professor of neurosurgery and pediatrics at Mount Sinai School of Medicine in New York and director of pediatric neurosurgery at Mount Sinai Hospital, reviewed Chandler’s neuroimaging and medical records in 2021 on behalf of the Southern Center for Human Rights, a legal nonprofit that represents Smith.

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How can real-world evidence support regulatory decision making?

European Pharmaceutical Review

The review summarised what the organisation has learned from conducting real-world data (RWD) regulator-led studies from September 2021 to February 2023. These contained mainly primary care medical records from European countries. Four studies were initiated via DARWIN EU ®.

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Lots of FDA Guidance, But Few Drug Manufacturing “Remote Interactive Evaluations” (We Would Call Them “Virtual Inspections”)

The FDA Law Blog

A phone call to FDA requested information about the number of Remote Interactive Evaluations (RIEs) that FDA has performed at drug manufacturing facilities since it announced in April 2021 that it would start using them as an alternative to on-site inspections. We should explain what RIEs are. Comments on the guidance are invited.

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