Thank you for the update and insight. Your posts make me feel like I have my own personal consultant in Asia!
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Andrea Chamblee Esq., RAC, FRAPS
Senior Counsel, Wilson Sonsini
This information and views expressed are provided in my capacity as an FDA and compliance professor at Johns Hopkins and George Washington universities, and as a RAPS Fellow.
This is not intended as legal advice. Consult a lawyer for your specific matter.
Maryland
United States
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Original Message:
Sent: 24-Jan-2022 16:37
From: Ames Gross
Subject: Korean Institute Calls For Regulation Of Wearable Health Care Apps
With the popularity of health care apps linked to wearable devices exploding in Korea, a government-affiliated medical research institute in the country is recommending authorities establish guidelines to ensure the apps are accurate, reliable, and effective.
The Korea Health Industry Development Institute (KHIDI) announced this fall it had drafted suggested guidelines on the more than 300,000 such apps it estimates are in circulation in the country. The guidelines include recommendations that the development of such apps be based on clinical evidence and systematic trials, and that their accuracy be verified by independent arbiters.
The draft guidelines are modeled in part on similar verification systems already in use in the United States and many European countries.
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Ames Gross
President
Pacific Bridge Medical
Bethesda, MD
www.pacificbridgemedical.com
contact@pacificbridgemedical.com
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