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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

Peter Marks at James Valentine ’s FDA Rare Disease Town Hall session at the DIA Annual Meeting last month (see Pink Sheet coverage here ), this Hub is intended to serve as the Center of Excellence that we in the rare disease community have been calling for its establishment over the last several years.

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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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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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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. The answer to that question can often be found in an assessment of where those big numbers originate.

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Wearables, Sensors, and Apps Part 1 – Updates on FDA’s PDUFA VII Goals for the Use of Digital Health Technologies in Drug and Biological Product Development

FDA Law Blog

DHTs have been used in clinical trials for decades in the context of measurements made when participants visit clinical trial sites. In March of this year, FDA convened the first public meeting, Understanding Priorities for the Use of Digital Health Technologies to Support Clinical Trials for Drug Development and Review.