Patients as Co-Creators
Patients as Co-Creators
H/T Gideon Rosenblatt
Real world usage furthering medical trials making patients co-creators.
#medicalresearch #clinicaltrials
Originally shared by Gideon Rosenblatt
21st Century Cures Act
New legislation is moving through Congress that will further define recently issued guidance from the Food and Drug Administration, regarding the agency's regulation over innovations in healthcare.
There are a number of interesting dimensions to the changes, but what most caught my eye are the rules around "Real World Evidence":
...The second guidance addresses the use of “Real World Evidence” in research. “RWE” derives from data collected outside clinical trials. Although not usually used to win approval of a new device, RWE can be used to gain the FDA’s permission for a device to be used for more indications that the one for which it was originally approved. What is the source of data to build the evidence? “The data is typically derived from electronic systems used in health care delivery, data contained within medical devices, and/or in tracking patient experience during care, including in home-use settings.”
In other words, we, the patients, will increasingly play a vital role in validating the efficacy of future healthcare innovations. The FDA is essentially acknowledging what the tech industry has long known: customers aren't just consumers -- they are co-creators.
http://www.forbes.com/sites/theapothecary/2016/08/19/artificial-intelligence-machine-learning-and-the-fda/#4bd1282a91ca
H/T Gideon Rosenblatt
Real world usage furthering medical trials making patients co-creators.
#medicalresearch #clinicaltrials
Originally shared by Gideon Rosenblatt
21st Century Cures Act
New legislation is moving through Congress that will further define recently issued guidance from the Food and Drug Administration, regarding the agency's regulation over innovations in healthcare.
There are a number of interesting dimensions to the changes, but what most caught my eye are the rules around "Real World Evidence":
...The second guidance addresses the use of “Real World Evidence” in research. “RWE” derives from data collected outside clinical trials. Although not usually used to win approval of a new device, RWE can be used to gain the FDA’s permission for a device to be used for more indications that the one for which it was originally approved. What is the source of data to build the evidence? “The data is typically derived from electronic systems used in health care delivery, data contained within medical devices, and/or in tracking patient experience during care, including in home-use settings.”
In other words, we, the patients, will increasingly play a vital role in validating the efficacy of future healthcare innovations. The FDA is essentially acknowledging what the tech industry has long known: customers aren't just consumers -- they are co-creators.
http://www.forbes.com/sites/theapothecary/2016/08/19/artificial-intelligence-machine-learning-and-the-fda/#4bd1282a91ca
Thanks Zara Altair
ReplyDeleteGreat find Gideon Rosenblatt
ping : Summit Medical Group HealthQuotes.ca Truehope Nutritional Support Ltd. Sherldine Tomlinson David Amerland Oleg Moskalensky
Thanks Zara Altair (and Coach G Moore).
ReplyDeleteWhat I can't figure out is how much of this is being pushed by industry lobbying.
Gideon Rosenblatt It seems to me that industry lobbying would have an interest because it's another way to get FDA verification. But, the industry lobby could shift like a spring breeze if snags appear. The lobby is about generating #profits .
ReplyDeleteZara Altair Agree !!!
ReplyDeleteGenerating Profits is the Only reason ... Nothing for the Wellness of fellow Beings (Humans and Animal Kingdom)
WOW am I talking about the Facebook mentality ... Sorry
Enjoy Your Weekend Zara