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What we know about taking patient consent in India: Notes from SFLC round-table on IT in Healthcare

MediaNama attended a round-table discussion on April 27th by SFLC.in on policy enabling Information Technology in healthcare. The round-table aimed to discuss questions around current and future regulation, the effect of government policy and technical aspects of providing healthcare using IT. Below are the main points made during the discussion. Quotes are paraphrased and not verbatim, they are unattributed since the discussion was held under Chatham House Rules. Taking consent from patients: who takes consent, and dealing with emergent conditions Taking consent from clinical trial participants: In the context of conducting clinical trials, an implied consent form is in place, wherein you obtain the consent of the patient, and it needs to be specified if the data is going to processed not locally, but in a second geography/country different from where its being collected. You have to explain to the patient what exactly happens with their data. We call the patients subjects and obtain their consent, and major hospitals are our sites. The ICF has to be obtained and explained by a doctor, so he will explain the drug that is being tested, and only then the trial will proceed. How taking consent changes in trauma and emergent medical situations: During a medical trauma, a hospital or doctor will administer acute medical care and take care of what the person is suffering at that moment. Subsequent data brought in by his friends and family can be used to give him further treatment. Emergent conditions like brain strokes require acute treatment,…

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