Relay-Version: version B 2.10 5/3/83; site utzoo.UUCP Path: utzoo!watmath!clyde!burl!ulysses!unc!mcnc!ecsvax!jwb From: jwb@ecsvax.UUCP Newsgroups: net.ai Subject: Re: computer ECG, FDA testing of AI programs Message-ID: <2140@ecsvax.UUCP> Date: Fri, 9-Mar-84 10:47:10 EST Article-I.D.: ecsvax.2140 Posted: Fri Mar 9 10:47:10 1984 Date-Received: Sat, 10-Mar-84 12:38:30 EST References: sri-arpa.17229 Lines: 27 An extract of a previous submission by me mentioned the overreading of an ECG interpretation by a cardiologist. What I meant (and what was not clear) is that the cardiologist is looking at the raw ECG, not the output of the computer (although a lot of preprocessing is often done which is hidden from the cardiologist--this is another different problem--at least it looks like what you would get from a standard ECG machine). On a related issue, medical decisions regarding the treatment of an individual patient *have* to be made by the local physician treating the patient (at least that is long standing medical practice and opinion). The overreading offered by the remote services is a look at the reconstructed input ECG by a Board Certified Cardiologist and is intended to be analagous to a "consultation" by a more experienced and/or specialized physician. The name of the service is Telemed, not Telenet as I incorrectly typed. Committees of the American Heart Association and the American College of Cardiology are attempting to set standards for computer (and human) interpretation of ECG's. A snag is that different preprocessing of the ECG's by different manufacturers makes it rather uneconomical to acquire a large number os "standard" ECG's in machine readable form. I think the FDA is looking at all this and I think under current law they can step in at their whim. So far they seem to be waiting for the above groups to present standards (since they don't seem to have the resources to even start to develop them within the FDA). Jack Buchanan Cardiology and Biomedical Engineering UNC-Chapel Hill Chapel Hill NC decvax!mcnc!ecsvax!jwb