Status
* Larry: Santosh and I had a few exchanges. Started listing references of microprocessors and compilers. 020_Embedded_Software.htm. Talked with DeeDee about website design. Needs approval from the AMA to use the device in a clinical setting, specifically and CPT at a minimum (procedure code) and possibly and ICD (diagnostic code). Most medical device com0p0anies start with a condition (anymore) (which needs to be done here - either treat something for which other's already treat or treat something which no one treats - an unmet need - clinicians encounter but have no way of dealing with - more research is needed about the biology, or the understand but don't have anyway to treat them - no existing technique. (Bob said Franz said he already had a code for this, possibly for the process for using a blood pressure mon8itor over a long time. So, how long is needed? What is this going to be used for, to determine if we have a device that is good enough? Bob says that measuring over 7 days will not tell us what the variability is, so are we planning this device correctly?
Germaine: There is a whole gamut of disorders of blood pressure variability. Hypertension is part of that. All of what we are picking up is a risk factor. So unless you can determine if you have this pattern, you cannot get an ICD. If you look at the incidence of morbid events, you already have normal tensive range, the higher the average pressure, the more likely the incidence of morbid tension later in life. The reason that people are treating hypertension today, it that it is documented that it leads to disease high risk for brain strokes and heart attacks. It is a condition that poses a risk, but not a disease. There has been a big shift in medicine, we are no longer just treating conditions, but we are also treating risk factors. If you order a 24 hr ABPM, you can get reimbursed. The cost difference isn't significant between a 24 hr or a 7-day ABPM. Currently, the 24 hr ABPM has been found useful for the hypertension. So, physicians can order it for difficult cases. But, we want to use it for preventative medicine, where there isn't a condition.
Bob: What measure do we need to determine if the device is effective. Usually, you compare it to another device, like a mercury sphygmomanometer.
Germaine: Hasn't the case been established by the approval of the class of ABPM?
Chris: If this is all that needs to be done, it must be established. We just need to document that reimbursement standards for ABPM exists. Maybe public health is a third scenario. For clinical (i.e. physicians are using it, what is the context), show that the need is well known and the ability to get reimbursed is documented (24 or 48 hr), so that what we want to achieve with a 7 day monitor slides into that/dovetails to it. Then, show it for education (most non-clinical settings - into the mainstream - non-physicians or researchers are using it, like a thermometer, what is the context?).
El: Our purpose is to make an ABPM for use in preventative healthcare. We need to be careful that by focusing on clinical reimbursement, we don't add requirements to the ABPM so that ultimately we end up with a device that costs so much it cannot be used for preventative healthcare. That path of seeking reimbursement may lead to a different outcome than the path that leads to lowest cost so it is affordable without a clinical condition.
Germaine: The seven-day cycle is important, and one-day cycle isn't adequate. We have data that shows that people with depression show this in a seven-day measurement but not in a one day.
* Chris: I'm doing research on how to do architecture, reading Ian Gordon's Central Software Architecture, discusses non-functional requirements, behavior between the architecturally significant, the abstraction level is relatively stable and consistent with the overall architecture, the interaction, structure and nonperformance such as performance throughput, interoperabilitty, and non-scalability,
* Germaine: I'm using a numerical filter provided by Larry.
Franz Halberg - Halbert Chronobiology Center
There is a meeting on Sept 23-24 in Baku, Russia.
We could serve 72 million with hypertension, if we convey the message of the IEEE as formulated by Larry, and built by Germaine to Azerbaijan and to the Japanese, etc. to implement the study of variability for monitoring solar variability. The Azerbaijani live in a region that shakes with earthquakes. The specific question they have is how the data flow of blood pressure or EEGs can be used with humans to explore whether there are harbingers of earthquakes in the human, telemetry of EEG, ECG and blood pressure, before the event, so that we can have a global monitor.
El: This is an interesting approach for exploring additional uses (applications) of human biological variability monitor data and may generate additional funding for the measurement and analysis.
Chris: Franz' hypothesis is interesting. It suggests that we might be able to ignore the clinical uses of ABPM, and instead focus on preventative healthcare by non-clinicians. If we do that, perhaps many of our requirements and constraints go away.
Germaine: If we do that, we may not be able to process the data in a research way (no IRB approval) or use it in a clinical setting (FDA approval) so we may have a system but it perhaps it may not be used. All of our researchers on the BICOS project are physicians. So, we need IRB approval to use this data.
Bob: Many people use ABPM in exercise.
Germaine: They don't do it around the clock.
Bob: Yes. They use it only when they are exercising.
This page is maintained by Ellis S Nolley. It was last updated on 18 July 2007.
The author(s) provide this information as a public service, and agree to place any novel and useful inventions disclosed herein into the public domain. They are not aware that this material infringes on the patent, copyright, trademark or trade secret rights of others. However, there is a possibility that such infringement may exist without their knowledge. The user assumes all responsibility for determining if this information infringes on the intellectual property rights of others before applying it to products or services.
Copyright (C) 2007 Ellis S. Nolley. Copying and distribution of this page is permitted in any medium, provided this notice is preserved.
Back to the Meeting Archive Page