Wednesday, June 22, 2016

New Draft Guidance for Medical Device Clinical Studies

Office of Women's Health, FDA

New Draft Guidance for Medical Device Clinical Studies

FDA’s draft guidance “Evaluation and Reporting of Age, Race, and Ethnicity Data in Medical Device Clinical Studies”  is now available on display in the Federal Register. 
This draft guidance contains specific recommendations to improve the design, conduct, and reporting of clinical trials to achieve better quality, consistency and transparency of data regarding the performance of medical devices within specific age, race, and ethnic groups. 
The specific objectives of this guidance are to:
  • Encourage the collection and consideration of age, race, ethnicity and associated predictive variables (e.g., body size, biomarkers, bone density, etc.) during the study design stage
  • Outline recommended analyses of study subgroup data, with a framework for considering demographic data when interpreting overall study outcomes
  • Specify the FDA’s expectations for reporting age, race, and ethnicity-specific information in summaries and labeling for approved or cleared medical devices
FDA has opened a docket for comment for 90 days from the date of publication. The docket number is FDA-2016-D-0734.
View Federal Register Notice

Upcoming Webinar: Workplace Policies to Support New and Soon-to-Be Mothers

The workplace can be a stressor for pregnant women and new mothers if they don’t have adequate support. They need a place to breastfeed or pump, pregnancy and parental leave, and resources to achieve a healthy work-life balance, or work-family fit.

Join us for a webinar on July 14 from 11:00 a.m. to noon, to learn about workplace policies that support pregnant women and new mothers. The webinar will introduce research linking workplace policies to women’s health and highlight strategies for making workplaces more supportive and equitable. The presenters are nationally recognized experts on workplace policy and public health, and they will discuss national trends as well as initiatives and campaigns that put women’s health front and center.

Register today!

Monday, June 20, 2016

New funding opportunity from RWJF

A doctor asks a patient how he is feeling in a cartoon illustration.Patients are shouldering more out-of-pocket health care costs, and they increasingly need and seek guidance from clinicians about the costs of care.

Resources to support clinicians in having cost-of-care conversations exist—but they need to be embedded into the clinical workflow in order to be implemented broadly; and they must be optimized for improving conversations with vulnerable populations in particular.

RWJF is releasing two calls for proposals to support cost-of-care conversations across different vulnerable patient populations, care settings, and geographic areas.

Up to $900,000 will be awarded for integrating cost-of-care conversation resources into the clinical workflow, with individual grants up to $250,000 for studies of up to 12 months.

Up to $1 million will be awarded for testing messages, best practices, and other principles for cost-of-care conversations with vulnerable populations, with individual grants up to $250,000 for studies of up to 12 months.

Submission deadline: July 27, 2016

Thursday, June 16, 2016

Webinar: Tools for Identifying Vulnerable Populations and Health Disparities

Tools for Identifying Vulnerable Populations and Health Disparities
Thursday, June 23, 2016
3:00 PM - 4:00 PM EDT

Register here now!
Description:This month’s webinar will feature John Moenster from the Institute for People, Place & Possibility (IP3). We will also have NACDD consultant Jeanne Alongi and Branalyn Williams from CDC discuss results from a Learning Needs Assessment administered to Chronic Disease Directors and their staff. 
John Moenster is Manager of User Engagement and Analytics at the Institute for People, Place & Possibility (IP3) and a member of the Community Commons team. He regularly produces webinars, trainings, and content for the Commons. Additionally, John works to understand how Community Commons can better serve its members through site metrics and analytics. John has a Bachelor of Arts in Communication from Truman State University and has been with IP3 since November 2012.
Learning Objectives:
1. Explain the purpose and theory of the indicators used to determine Vulnerable Populations.
2. Demonstrate how to access and use the Vulnerable Populations Footprint tool.
3. Demonstrate how to incorporate a saved footprint into a Community Health Needs Assessment.
4. Disseminate information from Learning Needs Assessment to Chronic Disease Directors and their Staff.

Intended Audience:
Chronic Disease and Health Promotion Directors
Chronic Disease Practitioner Network

Join us for this exciting webinar on June 23, 2016 from 3:00-4:00 PM EST.

Wednesday, June 15, 2016

Job opportunity at the UDOH Family Dental Plan

Utah Department Health, Family Dental Plan, Information Specialist 
(bilingual English/Spanish preferred)
Full time with benefits
Salary: $14.42 - $21.64 Hourly (based on experience and qualifications)
To apply go to http://statejobs.utah.gov/jobseeker/   Job# 08802
Closing Date 6/19/16

New Webinar Series: Fighting Hepatitis and HIV Co-infection in Minority Communities

OMH Resource Center logo. blue green and grey lines.
Hepatitis and HIV co-infection is a major concern among many racial and ethnic minority groups in the U.S. Prevention and education efforts are hindered by many challenges, including stigma, language barriers, cultural competency and knowledge among providers, and access to services in hard-to-reach communities.

The five-part webinar series examines the current state of hepatitis and HIV among minority groups, as well as best practices for culturally and linguistically appropriate testing and outreach efforts. 


The Office of Minority Health Resource Center kicks off a new webinar series designed to help health professionals, agencies and clinics get past these challenges and address the rising rates of hepatitis and HIV co-infection in their communities.

First webinar:
June 24 at 2 pm EDTTitle: Innovative Strategies for Addressing Hep C in Indian CountryRegister Now