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The ICH E6(R3) Guideline: A Major Update to Good Clinical Practice

FDA Law Blog

E6(R3) specifically acknowledges the rise of innovative trial designs such as adaptive and decentralized methods, while also encouraging the use of electronic informed consent and remote monitoring.

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MyChart Messages the Wild West of Patient Communication

33 Charts

A few ideas: Stronger technology governance of MyChart messages We want to call the MyChart mushroom an Epic problem. then educate patients and doctors Once we agree on how a tool will be used, patients need guidance. It’s everything written here about electronic health records. How do we fix this? Happy reading.

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Podcast: AI, innovation, and value-based care in medicine

Permanente Medicine

Nguyen shared the multiple benefits of an AI ambient listening tool — recently rolled out nationally to more than 25,000 Permanente physicians — that transcribes office visits (with patient consent) that can be edited and added to electronic health records. I know for a fact that the government or legislators looked to us in Permanente.

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AAP Updates Recommendations for Adolescent Contraceptive Counseling

Physician's Weekly

Counseling should account for and educate about reduced access to abortion services based on state law. Policies and products that support pediatricians in providing confidential and timely contraceptive care to adolescents should be designed by governments, insurers, electronic health care vendors, and health care systems.

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Stop the Presses! DEA and DOJ Fine eBay for not Reporting Sales of Tableting and Pill Press Machines

FDA Law Blog

Also, a DEA Form 452 report must be electronically filed within 15 days after the order is shipped. According to the eBay settlement agreement, the government contends that from October 2015 to the present, eBay did not comply with any of “the CSA’s reporting and recordkeeping obligations” involving thousands of transactions.

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Transgender Health, Aging, and Advocacy: A Podcast with Noelle Marie Javier and Jace Flatt

GeriPal

Just today (June 17th) as we record this podcast: Ezra Klein released a wonderful interview with Sarah McBride , the first openly transgender member of congress A judge ruled that cuts to NIH grants focused on minority groups, including transgender people, were illegal and ordered the government to restore funding.

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Improving Nursing Home Quality: Jasmine Travers, Alice Bonner, Isaac Longobardi, and Mike Wasserman

GeriPal

There have been multiple subsequent government reports on nursing home care, most recently was about eight, nine years ago from the OIG. Part of it’s what Mike was saying, it’s accountability as a country, as a nation and as the government. This is a problem that’s existed for decades. What are they accountable for?

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