article thumbnail

Vendor breach affects sleep study patients at Northern Light facilities

Beckers Hospital Review

The breach affected patients who received or were scheduled for sleep studies at three Northern Light facilities: Eastern Maine Medical Center, AR Gould Hospital, and Sebasticook Valley Hospital, the health system said in a June 27 statement. Compumedics began mailing individual notices to affected patients on June 27.

article thumbnail

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.

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

Trending Sources

article thumbnail

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). .

article thumbnail

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).

article thumbnail

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

FDA Law Blog: Biosimilars

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.

article thumbnail

Antimicrobial Choice

RX Note

Often, to find a quick answer for the antibiotic for a certain infectious disease, I will look up National Antimicrobial Guideline, 2019 or Sanford Guide to Antimicrobial Therapy. Example of patients with altered pharmacokinetics (e.g. before the availability of culture or susceptibility testing result).

article thumbnail

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

FDA Law Blog: Biosimilars

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.