iPhone EKG Case - Another piece in the Tricorder XPrize?

I thought the iStethoscope was a pretty good missing piece for the Qualcomm TriCorder XPrize.   I blogged about this before < here >. Here is another component which fits nicely.  It won't be long before a powerful point of care diagnostic smart phone finds it way to FDA approval - and an XPrize winner.

This $200 iPhone Case Is An FDA-Approved EKG Machine

HEALTH CARE IS HURTING, AND THE WORLD IS CHANGING. MORE AND MORE, HOSPITALS WILL FIT IN OUR POCKETS.

1 Comments

inShare

Most iPhone cases just protect your phone from drops. If you’re getting fancy, it may have a fisheye camera lens or a screen-printed back. But what about diagnosing coronary heart disease, arrhythmia, or congenital heart defects? The AliveCor Heart Monitor is an FDA-approved iPhone case that can be held in your hands (or dramatically pressed against your chest) to produce an EKG/ECG--the infamous green blips pulsing patient-side in hospitals everywhere.

“We think that EKG screening can be as approachable as taking blood pressure,” AliveCor President and CEO Judy Wade tells Co.Design.

There are already apps that take your heartbeat, of course. But there’s a big difference between the fast-paced standards of casual electronics and the strict sanctions of government-approved medical devices. “The heartbeat camera apps are good at wellness,” Wade admits, “but we see ourselves for use by people who want clinical-quality equipment.”

IMAGINE THE POTENTIAL: IN-APP PURCHASE FOR A FOLLOW-UP APPOINTMENT.

So unlike most iPhone cases that are squirted by Chinese factories at extremely high margins, AliveCor’s case has been in serious development since 2010. Aside from building the gadget itself, to become approved for medical use by the FDA, AliveCor had to participate in two clinical trials to field test both the hardware and the accompanying app. One study investigated how its single-lead EKG compared to a traditional 12-lead device, the other examined if 54 participants could figure out how to use the case properly, with no previous medical training. The latter study was not only successful but led to the diagnosis of two serious heart problems.

THE COMPLICATIONS OF INNOVATING UNDER THE FDA

AliveCor was lucky. Though it took about six months to get the application ready, the approval arrived well within the 90-day approval window, allowing the company to come to market sooner. It was a necessary hassle; FDA approval opens a lot of doors. Instantly, what could be considered some scam iPhone case was marketable to health care professionals--doctors--who’d most likely pay out of pocket for a $200 stethoscope replacement without blinking. FDA approval also allows doctors to prescribe, and potentially have insurance cover, AliveCor’s device for their patients to take home.

But even with an approval in-hand, AliveCor will continue to juggle complicated regulations to stay competitive in the market. For one, the approved monitor was designed for the iPhone 4 and 4S. Before AliveCor can release an iPhone 5 version with the exact same hardware internals, they will need to seek out additional FDA approval. (With previous approval and clinical trials to cite, the process is mostly a formality, but it’s still paperwork that takes more time and resources.)

THE REAL QUESTION IS, WILL FDA REGULATIONS LEAVE SPACE FOR THE LITTLE GUYS TO INNOVATE RESPONSIBLY.

The company also intends to release an over-the-counter version of the case. The good news is, this device will be eligible for coverage in most employee spending programs. But because of FDA regulations, this OTC version cannot provide the raw EKG data to a consumer who might not know how to interpret the esoteric waveforms. Instead, AliveCor will redesign the app to provide an infographic-esque interpretation of the EKG. “An EKG means something to a trained physician, but we can provide a lot of insights to an untrained consumer that might help explain what triggered a cardiac event,” Wade explains. “Like caffeine is a trigger. With an app, we see being able to offer more insight to an individual about their heart health.”

From a product design standpoint, this second-level data analysis sounds like an ideal, consumer-oriented decision. But from a consumer rights standpoint, why is any government agency standing in the way of consumer access to our own raw data? I can see how strongly my iPhone’s antenna is reaching the nearest cell tower, but I can’t see how well my own heart is ticking inside my body? How absurd is that? Interestingly enough, AliveCor is using this regulation to their advantage, banking on the health care model as it stands now. Its OTC device will offer services to refer you to a physician for deeper result analysis (and access to your actual waveforms, if you’re so concerned), which will provide a backend revenue stream beyond typical hardware sales. Imagine the potential: In-app purchase for a follow-up appointment.

An eagle at the Edinburgh Zoo that had been shot, but AliveCor’s case measured a heartbeat through its feathers. The eagle was deemed fit enough for surgery, underwent the procedure and lived. Needless to say, the device has veterinary applications as well.

THE FUTURE OF MEDICINE

For the time being, AliveCor is continuing to develop their EKG cases into a full line, including that OTC device, which will also be a universal version working for both iOS and Android. (Since the case actually communicates with the phone wirelessly, once the software programming is done, these product differentiations are largely cosmetic in nature.) No doubt, AliveCor sees the case as a stepping stone to the company’s overall vision, that “everyone should have their health at their fingertips,” Wade says. But the company will have to solve a lot of larger problems that the industry is struggling with to make that future a reality.

SHOULD MEDICAL DEVICES BE REGULATED TO AUTOMATICALLY DIAL 911 IN CASES OF EMERGENCY? 

While diagnostic devices may be coming to the phone, we still have no standards to get such diagnostic information back to our doctors. AliveCor explained to me that it can send a push notification to my cardiologist every time I check my heart, but does my cardiologist really want push notifications all day from their client list? Or worse, would any doctor want a devastating cardiac episode just sitting under 30 other messages in the iOS Notification Center? Should my phone text or not text emergency information? Should doctors be held accountable for app-based information? Should medical devices be regulated to automatically dial 911 in cases of emergency?

No doubt, AliveCor’s Heart Monitor is another case of affordable consumer technology outpacing our brick-and-mortar hospitals, but to the credit of our hospitals, affordable consumer technology is outpacing most of the world. Still, just as Domino’s has figured out to deliver me a pizza through an app (no doubt, saving a few cents in the process), so, too, will the medical community come around to juggling big data at the individual patient level. The real question is, will FDA regulations leave space for the little guys--the weekend app warriors and the Kickstarters--to innovate responsibly, at a price cheaper than clinical trials and a timeframe faster than paperwork?

Pre-order the Heart Monitor here.

[Hat tip: Co.Exist]

MARK WILSON

Mark Wilson is a writer who started Philanthroper.com, a simple way to give back every day. His work has also appeared at Gizmodo, Kotaku, PopMech, PopSci, ... CONTINUED

Father of medical informatics, Utah’s Homer Warner dies

In my eHealth studies I had not heard of Homer Warner, but I did hear about Intermountain Healthcare in Utah, where Warner was working, because they did a lot of advanced EHR informatics using HL7.  This story about how he came to use computers in the study of cardiology was fascinating.  

http://www.sltrib.com/sltrib/news/55391911-78/warner-medical-utah-homer.html.csp?page=1

Father of medical informatics, Utah’s Homer Warner dies

Groundbreaking work of cardiologist is still redefining medicine.

By Kirsten Stewart

| The Salt Lake Tribune

First Published Dec 03 2012 04:49 pm • Last Updated Dec 04 2012 08:09 am

Homer Warner, a Utah cardiologist widely recognized as the father of medical informatics, died last week from complications of pancreatitis. He was 90.

Warner’s research is still redefining medicine, colleagues say. Modern intensive care units can be traced back to the electronic systems he built to monitor heart patients in the mid-1950s. And his creation of one of the first electronic medical records in the ‘70s set the stage for a new academic field and multi-billion dollar health IT industry.

     

Photos

• 
• 
• 
• 
• 

At a glance

—

Funeral services

A public service will be held at noon on Thursday, Dec. 6, at the Foothill Stake Center, 1933 S. 2100 East in Salt Lake City.

In lieu of flowers, the family suggests donations to the Homer R. Warner Scholarship Fund in Medical Informatics at the University of Utah.

Online condolences may be left atwww.larkincares.com.

He had the mind of an intellectual and the soul of an adventurer, captivating University of Utah medical students in a speech just weeks before he died, said his son Homer Warner Jr. "He just had a quiet magnetism about him."

Warner checked into a hospital complaining of stomach pain before Thanksgiving, said his son. He died Nov. 30, about a week later, surrounded by friends and family.

A graduate of East High School, Warner earned his medical degree at the University of Utah in 1949 and then earned a doctorate in physiology from the University of Minnesota. While training in Minnesota, he worked at the Mayo Clinic with cardiologist Earl Wood, who spurred his interest in medical research.

He returned to Utah, where he opened a Cardiovascular Laboratory at LDS Hospital and studied waveforms as a potential path to diagnosing heart patients.

"His real genius was probably in that early work," said Homer Warner Jr. While taking an engineering math course to further his work in 1956, he once stayed up all night to analyze one heart beat using a 3-foot slide ruler.

"I got so excited because it was such an interesting way to look at things," Warner told Peta Owens-Liston, a freelance writer for the U.’s alumni magazine, in 2010. "This was a turning point for me, since it led me to the whole concept of using computers in medicine."

After the U. bought its first digital computer in 1960, Warner worked with graduate students to develop a tool to effectively diagnose congenital heart disease – but doctors were skeptical, he told Owens-Liston.

Two years later he became the chairman of what is now considered the first program to grant degrees in medical informatics. Then called the Department of Biophysics and Bioengineering, it was located in the U.’s engineering school.

In 1968, Warner wrote his first version of a software program to evaluate patient data to guide physicians. He had been inspired by seeing an Intensive Care Unit nurse overwhelmed by information from sensors.

"The venous pressure was rising, the arterial pressure was going down, and the cardiac output was dropping, and she didn’t know what to do," Warner told Owens-Liston.

As the HELP program, for "Health Evaluation through Logical Processing," was further developed, it expanded to include information about drugs, lab tests, pulmonary function testing, patients’ medical history and more. It is now considered one of the nation’s first electronic medical records – and is still operational 40 years later at Intermountain Healthcare hospitals.

"We clearly had a jewel. He gave us a huge advantage," said Intermountain’s Chief Information Officer Marc Probst.

Getting doctors to use computers is still challenging, but Warner chipped away at their resistance by providing them with not just data, but information with the power to improve care, he said.

In a 2011 announcement of the opening of the Homer Warner Center for Informatics Research at Intermountain Medical Center, the hospital chain’s chief quality officer, Brent James said, "Dr. Warner identified the field and then defined that field...It’s hard to describe that contribution, not just to Intermountain, not just to the medical profession, but to the patients that we serve."

Warner’s lab was moved to the U. in 1980 where he continued his research until retiring in 1996. He outlived two of his wives, Katherine Ann Romney and Jeanne Okland, marrying a third, June Okland Cockrell, who survives him.

Next Page >

Abundance - Peter Diamandis (and what's in it for eHealth)

This book by Peter Diamandis and Steven Kotler professes the exponential timelines of Ray Kurzweil and the remarkable inventions, technologies, philanthropists, and the BoP (bottom of pyramid) rising billions of people.

Looking for eHealth content is not that hard. Diamandis started the X Prize foundation and there is a competition for a mobile medical device that will diagnose a patient faster and with more accuracy than a human, based on the inspiration of the Star Trek Tricorder, which I blogged about before. We almost have IBM's Dr. Watson doing  alot of that (on the cloud for everybody), but not with the X-rays, ultrasound, blood pressure, blood sugar, etc.

I have heard a lot of these stories before in the news - the internet pommels us everyday with these stories, but still some of them remain most startling and inspirational. Take for example "Lab on a Chip":

"Harvard professor George M. Whitesides, a leader in this emerging field explains: 'We now have drugs to treat many diseases, from AIDS and malaria to tuberculosis. What we desperately need is accurate, low-cost, easy-to-use, point-of-care diagnostics designed specifically for the sixty percent of the developing world that lives beyond the reach of urban hospitals and medical infrastructures. This is what Lab-on-a-Chip technology can deliver.'

Because LOC technology will likely be part of a wireless device, the data it collects for diagnostic purposes can be uploaded to a cloud and anlayzed for deeper patterns. 'For the first time,' says Dr. Anita Goel, a professor at MIT who company Nanobiosym is working hard to commercialize LOC technology, 'we'll have the ability to provide real-time, worldwide disease information that can be uploaded to the cloud and used for detecting and combating the early phase of pandemics'.

There is a whole chapter on Healthcare.  I didn't know Diamandis also had an MD. Another great story is zero-cost diagnostics, and the discovery by Carlos Camara that Scotch tape can be used for X-Rays - the Tribogenics X-Ray Pixel.  There was a great story about in Nature.


There are other stories/inventions/visions in the book that caught my attention:

"The impacts of mobile telephony on health stretch from being able to quickly locate the nearest doctor to a smart phone app invented by Peter Bentley, a researcher from University College London, that turns an iPhone into a stethoscope, and has since been downloaded by over 3 million doctors. And it is only one of 6,000 health care apps now available through Apple."

CMA - Docs for Patients & EMRs

I have been seeing this and other spots on TV. Further info leads to the docsforpatients.ca  site and more information on the outspoken advocate for EMRs, Dr. Ewan Affleck. It is great to see more doctors advocate for Electronic Medical Records. Sponsored by the Canadian Medical Association.  This is why I still keep a cable TV subscription!

I’m Ewan Affleck, I’m a GP, and I live and work in Yellowknife, N.W.T.

The North is a remarkable place for those of us who have come to call it home. I’ve been here 20 years and it’s a privilege as a Canadian to get to know the North. It’s a big part of our identity but many of us never get here.

The health care system globally is under stress. In The North we’re in a bit of a fish bowl, which presents us with an opportunity to be creative and try to find solutions. We have this huge place – this vast territory with 42,000 people and 33 remote communities – and we have to provide some measure of equitable, efficient and safe care. That’s a difficulty, a challenge and a gift, all at the same time.

Last year, over a quarter of the population of the Northwest Territories was physically moved for health care purposes. That drives massive cost. We’re moving people over long distances when what we really need to do is share information over long distances.

Last year, over a quarter of the population of the Northwest Territories was physically moved for health care purposes

My work with health informatics systems started with an outreach clinic that I run at a women’s shelter. Obviously you can’t leave charts in an environment like that given security and privacy concerns. I had to transport charts in and out, and so I went and got an old airline trolley and I would take it down the road with this box of charts, and I thought to myself, there has to be a better way to do this.

I went and got an old airline trolley and I would take it down the road with this box of charts, and I thought to myself, there has to be a better way to do this.

I was very committed to making this outreach clinic work, so I thought whatever it takes I’ll do it. That’s how I started with digital charts and the territorial Electronic Medical Record. Now we have over half of the patients in the territory on that system, and the plan is to have the entire territory on this single charting system, and to have as many of the divisions within the health service on the system so we can provide quality care.  We can provide networked care in the patient’s chart.

As told to the CMA, abridged from a longer interview.

It’s Your Health! Learn more about reaching your fitness goals.
No-excuses ExercisesExercise in PregnancyClassical StretchKick it up a notch and take a hike!

Ethical hacking to prevent health records held for ransom

A story about hacking that had a different angle was of interest to our privacy and security group. In this scenario, the hackers did not maliciously penetrate a system to cause chaos and destruction, but to virtually hold for a ransom a huge store of health records and personal health information.

Hacker holds patient health information for ransom

A Virginia hacker is asking for $10 million in exchange for the safe return of the personal health and prescription drug information of 8.3 million patients, HealthLeaders Media reported on May 5.

The hacker allegedly stole the information from the Virginia Prescription Monitoring Program’s (VPMP) Web site, which tracks prescription drug abuse and contains 35.5 million prescriptions in addition to enrollees’ personal information, including names, social security numbers, and addresses.

The hacker, who replaced the VPMP site with a ransom note, claims to have deleted the original back-up file for the information and created a new password-protected back-up file.

The VPMP site and the Virginia Department of Health Professions site are both temporarily disabled and the incident is under federal investigation.

This is when I realized that healthcare institutions need certified ethical hackers. These are the "white hat" hackers, who have a code of ethics, who know how to find the flaws in system security and work to prevent the "black hat" hackers from gaining admission.  In fact one in our group who works in healthcare said "oh, we do that." It is good to know there are ethical hackers in healthcare.  One of my earlier posts on this blog was about a computer security expert who hacked his way into an insulin pump, which fortunately was his own.

The White Hat Ethical Hacker Code of Ethics:

This CODE OF ETHICS expresses the consensus of the profession on ethical issues and is a means to educate both the public and those who are entering the field about the ethical obligations of all e-commerce consultants. By joining EC-Council each member agrees to:

Privacy: Keep private any confidential information gained in her/his professional work, (in particular as it pertains to client lists and client personal information). Not collect, give, sell, or transfer any personal information (such as name, e-mail address, Social Security number, or other unique identifier) to a third party without client prior consent.

Intellectual Property: Protect the intellectual property of others by relying on her/his own innovation and efforts, thus ensuring that all benefits vest with its originator.

Disclosure: Disclose to appropriate persons or authorities potential dangers to any e-commerce clients, the Internet community, or the public, that she/he reasonably believes to be associated with a particular set or type of electronic transactions or related software or hardware.

Areas of Expertise: Provide service in their areas of competence, being honest and forthright about any limitations of her/his experience and education. Ensure that she/he is qualified for any project on which he/she works or proposes to work by an appropriate combination of education, training, and experience.

Unauthorized Usage: Never knowingly use software or process that is obtained or retained either illegally or unethically.

Illegal Activities: Not engage in deceptive financial practices such as bribery, double billing, or other improper financial practices.

Authorization: Use the property of a client or employer only in ways properly authorized, and with the owner’s knowledge and consent.

Disclosure: Disclose to all concerned parties those conflicts of interest that cannot reasonably be avoided or escaped.

Management: Ensure good management for any project he/she leads, including effective procedures for promotion of quality and full disclosure of risk.

Knowledge Sharing: Add to the knowledge of the e-commerce profession by constant study, share the lessons of her/his experience with fellow EC-Council members, and promote public awareness of benefits of electronic commerce.

Confidence: Conduct herself/himself in the most ethical and competent manner when soliciting professional service or seeking employment, thus meriting confidence in her/his knowledge and integrity. Extreme Care: Ensure ethical conduct and professional care at all times on all professional assignments without prejudice.

Malicious Activities: Not associate with malicious hackers nor engage in any malicious activities. No Compromise: Not purposefully compromise or cause to be compromised the client organization’s systems in the course of your professional dealings.

Legal Limits: Ensure all penetration testing activities are authorized and within legal limits. Involvement: Not partake in any black hat activity or be associated with any black hat community that serves to endanger networks. Underground Communities: Not be part of any underground hacking community for purposes of preaching and expanding black hat activities.

Now that's getting personal: how small data is the new oil

I am not sure what to make of the personal.com company and application. There is a health information component, making it relevant to this blog. I am not sure I am so hyper concerned about personal information that I would use the personal login to access my facebook account. I suppose I am more of an exponent of open data, and even big data for that matter. Don't get me wrong. I understand the need for privacy and security of data. But "small data is the new oil"? They really might have something here:

Small data puts the power and tools of big data into the hands of people. It is based on the assumption that people have a significant long-term competitive advantage over companies and governments at aggregating and curating the best and most complete set of structured, machine-readable data about themselves and their lives – the “golden copy”. With proper tools, protections and incentives, small data allows each person to become the ultimate gatekeeper and beneficiary of their own data.

Built on privacy by design and security by design principles, small data can help people become smarter, healthier, and make better, faster decisions. It can help people discover new experiences more easily, reclaim time in their busy lives, and enjoy deeper, more positive relationships with others.

Should diabetics eat grapes?

I was listening to an acquaintance of mine talk about her mother who was recently diagnosed with diabetes. She was debating with her whether or not grapes could be part of the diabetic diet. Where to get an answer on that one? Yes, make an appointment with a professional dietician, which is what she recommended to her mother.

But what do most people do? Right, they google. And, what do they find? Research has shown that most people will click on the first five search return links that come up (thus the lucrative power of Search Engine Optimization or SEO). But when searching for health information, which is one, if not the highest usage for internet searching, do most people know if they are getting reliable or trustworthy information? Anyone even heard of Health on the Net?

I just searched on "should diabetics eat grapes?" and I did not see some of the more trustworthy internet health sites out there, like mayoclinic.com or medline. I don't know if Canadians automatically go to their provincial health authority website to seek this information. There is a lot of research on health information seeking behavior, and what patients print off before they visit their family physician.

What I am getting at, is that the trend towards personalized medicine should be able to answer this question in the context of their personal health record system (which ideally has been prescribed or recommended to them by their personal family physician).  You could have a Dr. Watson type search engine answer the question. You could have data crunchers analyzing health information in the health record, comparing to the ocean of health data that could be analyzed. Genetic information could be a factor for grapes, blood type, and insulin levels. Socio-economic factors loom large, for example, what is a grape in a food desert?

But what I think the reality is, most people don't have personal health records or know how to set them up, and the personal health records that do exist, won't be able to automatically answer this type of question, though we all speculate that it should. The family physician should be answering this question, either through a referral to a nutritionist, or a diabetes guidance counsellor. 

And this has made me think that what we need are more self-tracking stations. These would be counselling services where people can go to learn and maybe even procure self-tracking technologies, like fitbit, personal health records, mobile smartphones with blood pressure cuffs, etc.  What if there could even be fMRI, ultrasound, and Transcranial Magnetic Stimulation machines in these stations. This would be one way to deconstruct medicine, and I would like to venture on this idea in a future post on practising medicine without a license. There are so many medical and other devices which can be used to support healthy living. Maybe the model of the York University "Health Coach" would fit this idea, or the Self-Tracking Station counsellor.