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Community Integration: Pushing the Boundaries for a Better World

Integrated Care News by CFHA

On October 6, 2017, a van loaded with medical supplies departed from the Health Center, bound for the local airport. The Holyoke Health Center, in collaboration with the Family Resource Center at Enlace de Familias , played a pivotal role in this local relief effort.

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Increasing Primary Care Research Workforce and Output through T32 Primary Care Fellowship Training [Education and training]

Annals of Family Medicine

CONTEXT Primary care (PC) is well-positioned to address rapidly evolving public health priorities and research meaningful to patients and other stakeholders. The 60+ Clinical and Translational Science Award (CTSAs)-supported institutional programs also offer robust training (e.g., SETTING: Academic medical center.

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At Long Last, FDA Unveils Plan for Rare Disease Innovation Hub

FDA Law Blog

Importantly, the Hub is intended to establish a new model within FDA, which leverages cross-Agency expertise in providing guidance and conducting reviews for products for rare disease populations. Early Direction for the Rare Disease Innovation Hub The Hub, which will be co-chaired by Drs.

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Insights into the design, development and implementation of a novel digital health tool for skilled birth attendants to support quality maternity care in Kenya

BMJ

doi: 10.1136/fmch-2020-000845 The appetite for and ability to collect accurate digital patient-level data in low-resource settings has fueled numerous massive global health initiatives. As impressive as these large numbers may be, the question that is less often asked is “How much of that big data is actually helping us do better?”

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Power to the Patient with Patient Generated Health Data

FDA Law Blog

Lenz, Principal Medical Device Regulation Expert — FDA’s Center for Devices and Radiological Health (CDRH) recently partnered with the Digital Medicine Society (DiMe) to host a two-day workshop to help advance the use of patient-generated health data (PGHD) to support improved clinical trials, medical device development, and regulatory science.

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Let’s Listen to Patients: FDA Releases Final Guidance on Patient Engagement in the Design and Conduct of Medical Device Clinical Studies

FDA Law Blog

Bauer, Senior Regulatory Drug Expert — Our readers probably know that we value and advocate for patient engagement as an essential component in the development of medical products (see our firm’s commitment here ).

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The FDA PDUFA VII Goals Letter (FY 2023-2027): A Review of Our Top 10 Commitments

FDA Law Blog

From new initiatives to facilitate faster reviews for new indications under the Split Real Time Application Review (STAR) pilot program, to bringing new meetings under PDUFA goals, to continued support for rare diseases and incorporation of the patient voice, the goals letter revealed a good number of welcome announcements.