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As originally asked by Kelly O’Rear. How will they affect patient care? How will they affect security and privacy in the healthcare setting? Mike Plishka In my opinion, the ultimate platforms of the future, when they solicit patient interaction, will be less healthcare oriented and more ‘gamish’ in their feel-the person won’t use it as a healthcare app at all, but to do something else. Regarding healthcare apps, for better or worse, the FDA is hard at work trying to figure out how to deal with these little monsters 😉 Emad Baba John Strupat You ask about improving healthcare. One answer will come from looking closely at who would benefit from success of this technique and who would be threatened. John Strupat As an example on the fringe of healthcare, who pays out when your elderly parent’s wireless call button doesn’t “work” so help does not arrive in time? Extend that scenario to the many proposed apps that would stream biophysical data for monitoring, diagnosis, etc. The FDA may decide that the benefits outweigh the risks and allow you to market the device, but that will not protect you in a product liability case. Zeljko Roncevic Kelly O’Rear John Strupat However, must agree with Bruce that the payment side of this kind of technology is a real problem. Many entrenched medical groups are against any reduction of their control and power. Some may call that politics but it is where the dinos roam free. However, the power of the physician and the hospital to control this may be changing with the HMOs. insurance companies and even Governments who are looking for ways to keep people healthy and out of hospital care. Note that I did not say “patients”! Earlier responses highlight a huge potential market to wirelessly monitor data from people, ideally using expert systems that need no human intervention to analyze it. What it is going to take to make this happen is a fundamental shift in the expectations for health care that is not hospital centered or physician centered. I expect to see these technologies used in Asia first and spread from there but may never make it to the US. Zeljko Roncevic Bruce Grayson Zeljko Roncevic Kelly O’Rear Zeljko Roncevic John Strupat I see a clash of the cowboy culture of software developers from the consumer world (think cell phone apps) vs. the anal, fussy types who write tedious software development protocols where life is on the line (think nuclear power plants, aircraft, military systems). 1. Requirement for a formal software development procedure that demands treating medical software as either a stand-alone medical product or as an integral part of a medical device. Endless V&V and stress testing. Obvious legal implications for any software involved in the diagnosis or treatment of a patient, including drug delivery, as in product recalls and other expensive fun. FDA is involved in this, of course. 2. The need to use an operating system qualified to an international standard for appropriate use in a medical device. 3. Formal risk analysis and hazard analysis of the implications for all imaginable software/hardware combo defects, especially with wireless communication, of signal loss, dropout, hardware reset, etc. What does 30 seconds of signal loss mean to a wireless system transferring ECG signals to a monitoring station? I’m thinking it depends on exactly what is supposed to happen when the ECG signal stops, but that point of view may be different with the patient, the health care provider, the company involved in the system, and the legal folks who await the appearance of new technologies and new problems to resolve in court. Likely some other medical sector issues involve turf wars between various health providers, concerns about confidentiality of data, ownership of a patient’s data and storage retrieval of same, plus who is going to pay, etc.. Issues with biophysical sensors are an order of magnitude more complex than software and wireless communication. I would appreciate seeing a clinical use contactless ECG sensor that can match a 25 cent paste electrode on a wire, after more than 30 years in development? Perhaps other issues can be seen by looking at an ongoing post in this group where physicians and medical device folks are debating the replacement of the basic stethoscope with an electronic version. Strong support is there to keep the 1920’s design as it is since that darn electronic stuff is just too complicated, and probably doesn’t work either! Shannon Prather Bruce Grayson Mervi Hamalainen Kelly O’Rear Shannon Prather I’d like to see some of these mobile devices have improvements in durability. Glass fronts are just too fragile for some workplaces (e.g., working around autistic or severely OCD patients). Bruce Grayson Alfredo Carrero, PMP, SSGB Marked as spam
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