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.

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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.

Seniors: Stop Playing Bingo and Get into the Gym!

I've included an article from the New York Times that's not only worth reading, but passing around no matter what their age, but especially to those who are 50 years old and older. Here's the bottomline: resistance/strength training using weights and/or bands may be the key to staying out of (or at least postponing as long as possible a stay in) a nursing home when you grow older.

A relative of mine told me that once he reached 80 years old that was when he felt himself truly growing old: loosing his strength and stamina. I had always assume that 80 was a point in life when the body reached a point where no matter what you did, everything would decline ending in death. 

Well ... that may not necessarily be the case. My relative never engaged in any resistance training ... at all, ever. Certainly not when I knew him. He was active, but never when into a gym to lift weights or engage in any resistance training. Turned out that was a significant mistake. 

Here's the link to the article: https://www.nytimes.com/2018/09/03/well/live/preventing-muscle-loss-among-the-elderly.html

Here's an interesting quotes from the article:

...  many people past 50, have a condition called sarcopenia (my emphasis) — a decline in skeletal muscle with age. It begins as early as age 40 and, without intervention, gets increasingly worse, with as much as half of muscle mass lost by age 70. (If you’re wondering, it’s replaced by fat and fibrous tissue, making muscles resemble a well-marbled steak.)

“Sarcopenia can be considered for muscle what osteoporosis is to bone,” Dr. John E. Morley, geriatrician at Saint Louis University School of Medicine ... he pointed out that up to 13 percent of people in their 60s and as many as half of those in their 80s have sarcopenia.

But — and this is a critically important “but” — no matter how old or out of shape you are, you can restore much of the strength you already lost. 

So, what are you waiting for? If you’re currently sedentary or have a serious chronic illness, check first with your doctor. But as soon as you get the go-ahead, start a strength-training program using free weights, resistance bands or machines, preferably after taking a few lessons from a physical therapist or certified trainer.

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And by the way, you'll need to increase your protein intake as well. Read the article. I think you'll find it to be of value and something to place in your personal archive.

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. 

Public Health Crisis: Suicides

This is a public health related piece. I produced a video about suicides. The data that I analyzed was from the Centers for Disease Control.

Suicide has been on the public radar recently because of the scrutiny it has received in the press. And the concerns expressed in the press about the rising numbers and rate of suicide.

When I was in college, I was taught that suicide was a largely based on the victim's emotional state. That the answers of how to address it were to be found in psychology and psychiatry. That may have been true then, but the data that I analyzed, that you will see in this movie, says that suicide may now be more of a socio-economic problem.

Here is the link to the video:

Let us know what you think.

Public Health Alert: Centers for Disease Control records 72,300 Drug Related Deaths in 2017

Here is the article from the New York Times reporting the number of drug related deaths from the Centers for Disease Control (CDC) for 2017.

https://www.nytimes.com/2018/08/15/upshot/opioids-overdose-deaths-rising-fentanyl.html?em_pos=small&emc=edit_up_20180815&nl=upshot&nl_art=0&nlid=67594383emc%3Dedit_up_20180815&ref=headline&te=1

In my own analysis https://professionalpredictivemodels.blogspot.com/2018/07/drugs-deaths-1999-to-2016-and.html my worst case prediction was for approximately 69,000 in 2017. To have a worst case exceeded by over 3000 deaths is a stunning development. My worst case prediction for 2018 is for the number of deaths to be between 76,000 and 77,000. And by 2025 my worst case prediction is for the number of drug related deaths to be between 150,000 and 160,000. I have had a difficult time believing the trends that the numbers appear to show. They seem unbelievable, but given that my own worst case, my own worst fears have been outstripped by the actual numbers ... well it now it appears that my own worst case fears may exceeded by reality.

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.

New York Times Magazine Article: Losing Earth - CO2 concentration in the atmosphere and it's relationship to global average temperature

This is related to public health not just for now but in the future as well. Here's the link to the article: https://www.nytimes.com/interactive/2018/08/01/magazine/climate-change-losing-earth.html This article is definitely worth your time.

I use this as a lead in to something that I posted on my other blog, Professional Predictive Models. I did this analysis on the connection between CO2 concentration in the atmosphere and it's relationship to the global average temperature. The strength of the relationship of these two measurement actually startled me. Here's the link to the blog post: https://professionalpredictivemodels.blogspot.com/2018/08/relationship-between-carbon-dioxide.html

Article: Wearable Technology Is the Future of Healthcare

A bit of light reading about wearable fitness and medical devices.

Here's the link to the article: https://www.hcanews.com/news/wearable-technology-is-the-future-of-healthcare

An interesting quote from the article ...

There is no doubt that the adoption and retention of medical wearable devices will, at least for now and the foreseeable future, outrun that of general fitness wearable devices. This is understandable, as they fulfill a direct and current need for the consumer. However, my belief is, and I assume yours too, if you believe in prevention over treatment, that the more general one of these two has the feared but powerful potential to truly change the status quo. Where now, overall health goes down just before the age of 50, general fitness wearable devices could move up that number.  ...

Drugs Deaths: 1999 to 2016 and Predicting Outcomes in Future Years

I write another (new) blog that dedicated to statistical analysis of a variety of sources of data and to predictive models. I recently wrote an article that is public health related. Although it has nothing to do with medical devices, it nevertheless is related to public health, treatment and sorry to say, death rates.

Here's the link to the article.

https://professionalpredictivemodels.blogspot.com/2018/07/drugs-deaths-1999-to-2016-and.html

Here is a preview:

The Centers for Disease Control (CDC) has a comprehensive online database known as Wonder (https://wonder.cdc.gov) that is accessible to all. So if you have public health related questions, the data to answer them can be found in Wonder.

Unless you've been living under a rock, you know that deaths from drug overdoses particularly opioid related deaths have been steady increasing. I am interested in not only in the number of deaths, but the rate of increase and what that suggests for the future. I believe you will find the results of my analysis both interesting and troubling, particularly for the future.

Here's a chart showing the number deaths from 1999 to 2016:

...

Using the equation derived from the 2008 to 2016 data, the picture that arises is much more concerning. In fact the crude rate in 2025 is twice the rate predicted by the trend line equation derived from the 1999 to 2016 data. This suggests that the number of drug related deaths would be near 500,000 by the mid 2020s and that the number of drug related deaths during the 2020s would be closer to 1 million to 1,500,000 where the number of deaths per year would be no less than 100,000 and possibly up to 150,000 each year. Most of these deaths would come about as a result of opioid overdoses.