Article: Year of Telehealth

Here's an article telling us what lots of us already have learned, that telehealth is an up a coming method of providing effective and cost-effective as well as continuous medical care where ever a patient may be. Here's the link to the article: https://www.beckershospitalreview.com/telehealth/dr-toby-cosgrove-2019-will-be-the-year-of-telehealth.html

Here's a quote from the article that I think is of interest:

"[Oakland, Calif.-based Kaiser Permanente] is seeing over 50 percent of their patients distantly," Dr. Cosgrove told CNBC.

What Cosgrove isn't telling us is how telehealth is being provided. Telehealth is pretty loosely defined. It can mean that patients have access to a health care provider through chat or the telephone. Or it can mean something more sophisticated such as continuous medical-device communication and automated monitoring. One way or another telehealth is clearly on the rise and will likely become the standard for providing care.

Careband: Keeping track of those with dementia

I was at an evening venture capitalist meeting on 13 November 2018. I'm not a venture capitalist but I have a few connections to this community and I periodically receive invitations to their meetings. Most of the time I pass on attending. I'm interested in science, mathematics and technology. VCs are interested in ways to make money. Nothing against them. We just live on different planes of existence.

However, I attended this meeting because I read the description of one of the companies doing a presentation, careband (http:www.careband.co).

careband

Careband provides a capability to track the location of people with dementia. This is a more difficult problem than you might imagine. In institutions, patients with dementia are known to wander away: from the institution, from their homes, from family members. The patients do not know where they are or how to return. Institutions who care for dementia patients frequently need to find their patients who have wandered away from the institution's grounds or to areas of the institution that caregivers do not expect that they would be able to wander. 

Thus there's a clear need to be able to keep contact track of dementia patients. To know where their location at all times and be notified when they've wandered off the grounds of the institution.  Here's a page from the careband.co website that summarizes the capabilities of their system.

The diagram above shows the elements of system for patients and customers/caregivers -- those responsible for caring for the dementia patient(s). Caregivers can see at a glance the current location of each patient. Each dementia patient wears a band about the size of a large wristwatch on the wrist that periodically sends a location related message to the network. All data is sent to careband's cloud server system. Patient location data is made accessible to the caregiver systems that are connected to the cloud server system.

The wrist bands connect to the Internet to the low-power communications system: LoraWAN. More information about this wireless data communications network is available here: https://lora-alliance.org/about-lorawan The LoraWAN network is a low-power, low-speed (0.3 kbps to 50 kbps) but long distance (up to 3 miles from an access point outside) and robust wireless communications system. 

The wristband also includes Bluetooth that is used to provide indoor location data. And an accelerometer has been included to provide information regarding whether the patient has moved his or her body during the reporting period. 

I am not familiar with all of the current capabilities of the careband.co system. However, I know that the wristband continually transmits to the cloud the following data:

• Patient ID data
• Transmission time 
• Location data
• Movement (whether or not the person has moved from the time of the last data transmission and the time of the current data transmission)
• Battery charge level

How careband.co is currently analyzing is something of which I am presently unsure, but there are a number of pieces of information that can be derived from this relatively small amount of data. Here's what's possible:

1. Current patient location
2. Map of patient's activity and the distance covered over time
3. Amount of time that the patient was moving
4. Alarm initiation: should the patient stray away from the institution, the system can automatically notify the caregivers. (Boundaries should be able to be drawn on the display.)
5. Trend and trend line analysis for patient activity time and distance covered. These could be indicators of the patient's cognitive health. Significant deviations from calculated trend lines could be indicators of a slip or improvement in a patient's cognitive and/or physical health.
6. Suggest that the patient has removed the band from his or her wrist (when the patient appears not to have moved during normal activity time) or that the patient maybe in distress or died.

There could be more information that can derived from the wristband data that I have yet to think of. As I come up with additional thoughts regarding this, I shall post them.

Upgrades to the wristband could include pulse oximetry and pulse rate data. Again, there are other capabilities that could be added that I have yet to think of.

Since the transmission speed is so low, careband.co will likely need to develop a data compression system to effectively communicate this data back to the cloud server system. 

Careband.co is one more interesting product for remote medical monitoring. It's not designed for remote patient management largely because most patients will normally be closely supervised. However, it could be an aid to enable people with dementia to live for a longer time in their own homes. The benefits to both the patient and to society are massive. Six months to a few years of being able to live in one's own home would improve both the quality of life for people with dementia and significantly, dramatically reduce the cost of care.

I shall continue to monitor careband.co's progress. Stay tuned.

Careband.co plans on making their products available through medical device distributors. Their products are not yet commercially available. They are about to manufacture the wristband. Their wristband has been approved by the FCC. FDA approval is not required.  If you are interested in purchasing their product, please contact them at care band.co.

I should mention that careband.co is looking for investors. If you're interested in what careband.co is selling, please contact them directly using the URL listed above.

Apple Watch 4: New York Times Review

Here's an article reviewing the Apple Watch 4 that was published in the New York Times on 19 September 2018.

Here's the link: https://www.nytimes.com/2018/09/19/technology/personaltech/apple-watch-series-4-review-health.html?em_pos=large&emc=edit_ct_20180920&nl=technology&nlid=67594383edit_ct_20180920&ref=headline&te=1

As of the posting of this article, Apple has yet to release their ECG app -- the thing I guess that most of us have interest with regards to the Apple Watch 4. It's the one thing that moves the Apple Watch 4 from a consumer to a medical device and a hardware platform on which to base medical applications and services. So, until the ECG application is available, I'm holding off on reviewing the Apple Watch 4.

Apple Watch 4 -- FDA Announcement: Statement from FDA Commissioner Scott Gottlieb, M.D., and Center for Devices and Radiological Health Director Jeff Shuren, M.D., J.D., on agency efforts to work with tech industry to spur innovation in digital health

The FDA just provided what amounts to a "shout-out" to companies that design and manufacture intelligent, wearable devices that include medically-related monitoring devices and specifically, the Apple Watch 4.

Here's the link to the FDA statement: https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm620246.htm

And here's an interesting quote from the announcement:

... [There have come] a new swath of companies that are investing in these new opportunities [e.g., wearable, intelligent monitoring devices measuring medically-related, physiological characteristics with analysis capabilities.] These firms may be new to health care products and may not be accustomed to navigating the regulatory landscape that has traditionally surrounded these areas. A great example is the announcement of two mobile medical apps designed by Apple to work on the Apple Watch. One app creates an electrocardiogram, similar to traditional electrocardiograms, to detect the presence of atrial fibrillation and regular heart rhythm, while the other app analyzes pulse rate data to identify irregular heart rhythms suggestive of atrial fibrillation and notify the user. The FDA worked closely with the company as they developed and tested these software products, which may help millions of users identify health concerns more quickly. Health care products on ubiquitous devices, like smart watches, may help users seek treatment earlier and will truly empower them with more information about their health.

---------------
I find it interesting that Dr. Gottlieb states that the Apple Watch analyzes pulse rate data, not the ECG, to detect "rhythms suggestive of atrial fibrillation." Yeah, that's a way to do it, but analysis of the ECG is a much better way. When I do a deep dive on the Apple Watch 4, I'll look into this and questions like it.

Apple Watch 4, Preview of Medical-Monitoring Features

Here's an article regarding the Apple Watch 4 and what are suppose to be built in medical monitoring features.

Here's the link: https://www.mobihealthnews.com/content/apple-watch-series-4-will-have-fda-cleared-ecg-fall-detection?mkt_tok=eyJpIjoiTkRVMk0yVmxNamsyWkRneiIsInQiOiJjWXRoaVpENmhJYlBRNFlzVVBYZ3hrc0VEVFdsYmNLUG1FQUIrQmcyMnVHMTRwSnBORDh6cW1Da1kzbjJqS2JxbHcydjRuTk0zaG5qRzBvMFR1MmdiMmZyNGhyXC9SZmYyYkduaSs5R0tyRG85TXkrMHVxTnFFYXFrVE5jWHpIRWwifQ%3D%3D

Here's the list of new medically-related features:

1. ECG (30 second rhythm "strip")
2. A-Fib detection (of course, if you're paying attention and you know the symptoms, you'll probably know sooner than the watch.)
3. Fall detection (as in when the person falls, the watch detects that it has occurred)

All information is sent back to Apple Health Records where all this information be accessible to a physician/cardiologist.

Apple has received FDA approval, according to the article. 

I'm not going to comment until I've had a little more time to study the Apple Watch 4 except to say, if you can detect A-Fib, then why not V-Fib? V-Fib is much more life threatening. Also too, if you've got a 30 second rhythm snap shot, you can do a lot with that. 

I'll touch on these and other questions regarding the Apple Watch 4 and Apple's effort to product a remote medical monitoring device and medical monitoring system later. 

Measuring cortisol — the stress hormone, remotely

Having the ability to remotely and continuously measure the level of a stress-related hormone would seem to be something of real value.

A new wearable biosensor, developed by the Salleo lab at Stanford, measures the amount of cortisol in a person’s sweat. 

Here is the link to the announcement/article: https://www.medicaldesignbriefs.com/component/content/article/mdb/insider/32762?utm_source=TBnewsletter&utm_medium=Email&utm_campaign=20180808_Medical_Newsletter&eid=376600177&bid=2199287

FCC approves telemedicine pilot for veterans, low-income, rural Americans

I'm actually surprised that this trial had not been approved earlier. Here is the announcement from the FCC.

 This is a link to an article that provide more detail on this program.

https://www.mobihealthnews.com/content/fcc-approves-telemedicine-pilot-veterans-low-income-
rural-americans?mkt_tok=eyJpIjoiT1dJNVl6UmxaVFExT1RkaCIsInQiOiJrb1B5Y0drbTRBMzRoMHFcLzBpUlpCTVljT1lBUGhhcUNCazA2RndKOW8zXC94dTFVSU5ua1VYY1NzeHBQazRsYW5hMkdsaTRETndXb01CTDZjN1Zva2VRYmRIUElic0FCc21BYVowSWdFTGVtTSt1Y2kxTXFGSHRuYlNCcitSRU5TIn0%3D

Since this is a pilot program, data should be collected about it's effectiveness. This is something that those who are interested in medical remote monitoring and remote patient management should be interested in following. I know I will.

Apple Watch 4: Will it be suitable as a remote medical monitoring device? Part 1

When I first commented about the Apple Watch as being a possible platform for a remote medical monitoring system in 2015, I was initially excited about the possibilities. Sadly, the technology in 2015 was not quite ready as a platform for remote medical monitoring systems. However, Apple may be turning a corner with the Apple Watch 4 due to be released in Fall 2018. 

To be an effective remote medical monitoring and remote patient management device, the Apple Watch will need to reach acceptable levels of performance in the following seven areas of concern:

1. Bio-sensors
• Built in: are there enough bio sensors with enough resolution?
• Extended: the capability to have additional bio sensors that communicate wirelessly with the watch?
2. Communications over the Internet: Is there a reliable and secure means of communication back to the patient's monitoring system? And the means to communicate with the patient over that same communications channel(s)? 
3. Processing capability, hardware and software: Does the watch have the processing capability to host medical applications?
4. User interface: Visual, touch screen - will patients be able to interact with medical application using the touch screen? Will the watch have an effective audio user interface in order to hear instructions and make requests of the application running on the watch?
5. Reliability: Will the hardware and software reliable enough for a remote medical monitoring and patient management application to run on it?
6. Battery life: When running a remote medical monitoring and patient management application(s) on the watch, will the battery life before needing to recharge be acceptable?
7. Rugged: Is the Apple Watch 4 rugged enough to be a remote medical monitoring and patient management device?

I'm going to touch on each of the areas of concern regarding the performance of the Apple Watch 4.

1. Bio-sensors: I'm not going to address this issue until the Apple Watch 4 has been released. Once it has been released, I'll write an article specifically discussing this topic.
2. Communications over the Internet: A model of the Apple Watch 3 does have the capability of communicating over 4G so reliable communication over the commercial wireless provider networks is possible. We can assume that this capability will continue to the next release. So communications capabilities are likely to be adequate. 
3. Processing capability, hardware and software: Improvements in both are promised over the Apple Watch 3. We can probably assume that hardware and software capabilities will be adequate.
4. User interface:
• Visual, touch screen: The Apple Watch screen has been targeted to those with good visual acuity (with or without glasses) and fine finger control to be able to use the touch screen effectively. Current reports say that the screen will be larger than the Apple Watch 3. Nevertheless it's still a small screen. 
• Auditory: The Apple Watch 3 has Siri, meaning it does have an auditory user interface. More on this after the release of Watch 4.
5. Reliability: Apple has made positive strides in reliability with each release of the Apple Watch. We can assume that this will continue and that the Apple Watch 4 will be reliable enough to serve as a platform for remote medical monitoring and remote patient management applications.
6. Battery life: The Apple Watch 3 has a reported battery life of up to 18 hours. Again Apple has continued its improvements in this area. Patient medical monitoring should be continuous and without long breaks. Even with one or more days of battery life, the watch will still need to be changed and that could take hours. However, having said that, the price of an Apple Watch (because of the ruggedness requirement) that would serve as a remote medical monitoring and patient management device would be around $600. As medical devices go, that's inexpensive and inexpensive enough so that the patient could or should have at least two Apple Watches that would enable the patient to switch watches when necessary. That would place a burden on application software developers to manage when patients change watches, however, this should be manageable.
7. Rugged: The Apple Watch 3 has a version in a stainless steel case. This should be adequate for most situations. Also the issue of reasonably low price and the ability to have redundant watches should effectively address this issue.

15 Game-Changing Wireless Devices to Improve Patient Care

I happened across this slide show today and decided to share it.

https://www.medscape.com/features/slideshow/wireless-devices#17

Remote monitoring has by implication another side to it: remote patient management. The remote monitoring side of these devices seem to be on a strong, positive path of development, but I'm not seeing the same level of development on the remote patient management side. That piece of seems to be lagging and probably for good reason: it's the more difficult. And I can say that from experience working in the area. In addition, it will likely require further development of supporting automation, that is, artificial intelligence or expert systems.

Article: Remote Monitoring of Heart Failure Patients

Although this article was published in 2013, it's findings are still applicable today. Moreover, there is applicability of this system remote monitoring and remote patient management to patients with other chronic conditions other than heart failure. 

I have experience with engineering methods to support remote monitoring and treatment of heart failure patients and this article is an extensive review many of the systems that were and would be coming available in 2013 and later.

Here is the link: Remote Monitoring of Heart Failure Patients by Arvind Bhimaraj, M.D., M.P.H. I recommend this article if you have an interest in many of the details of remote monitoring and remote patient management.

Heart Failure

Heart failure is a chronic disorder and requires continual monitoring and management. The management of heart failure patients remotely can serve as a model for managing patients with other chronic disorders such as diabetes or COPD.

Article Abstract (from the article)

Heart failure continues to be a major burden on our health care system. As the number of patients with heart failure increases, the cost of hospitalization alone is contributing significantly to the overall cost of this disease. Readmission rate and hospital length of stay are emerging as quality markers of heart failure care along with reimbursement policies that force hospitals to optimize these outcomes. Apart from maintaining quality assurance, the disease process of heart failure per-se requires demanding and close attention to vitals, diet, and medication compliance to prevent acute decompensation episodes. Remote patient monitoring is morphing into a key disease management strategy to optimize care for heart failure. Innovative implantable technologies to monitor intracardiac hemodynamics also are evolving, which potentially could offer better and substantial parameters to monitor.

My Analysis

With the advent of smartphones and increasingly sophisticated, smaller and lower power bio-sensors, remote monitoring and remote patient management of all types of chronic conditions should be on the rise. Furthermore, the rise and acceptance of computerize expert medical systems (artificial intelligence), should make remote monitoring and remote patient management a first choice. Not only will this lower costs, but as we have seen it: increases patient satisfaction and mobility, enabling a patient to spend time traveling and enjoying the life that remains.

One more thing ... and I have to add this as a point of pride, a quote from the article:

Also, advancements in implantable wireless technology seen with the pulmonary capillary pressure monitoring device CardioMEMS® (CardioMEMS, Inc., Atlanta, GA) and the left atrial pressure monitor HeartPOD™ System (St. Jude Medical, Inc., St. Paul, MN) or Promote® LAP System (St. Jude Medical, Inc., St. Paul, MN) bring us closer to finding the holy grail of home monitoring systems. (my emphasis)

I had a part in SJM's LAP project. I was working at SJM when this project was in the state of early patient trial. The project manager needed assistance with issues related to and testing of operation of the user interface including the how the computerize system would interact with patients to collect necessary data and provide the patient with directions on what to do to manage their current condition -- mostly, taking medication and performing certain activities. I provided that assistance, design direction and usability testing for this early stage product. Although I haven't seen this system in it's commercial form, I suspect that a lot of what I did was included in the commercial product. The "holy grail" comment is personally gratifying. And I should mention that my experience with the LAP system was one of this things that lead me to starting and continuing with this blog.