Diagnosed by App: Medical Testing in the Palm of Your Hand
Urinary tract infections aren't life-threatening, but they can be excruciatingly painful and debilitating.
"Overnight, I'd be gripped by this searing pain and I can barely walk," says Ling Koh, a Los Angeles-based bioengineer. But short of going to the ER or urgent care, she'd have to suffer for a few days until she could get in to see her family doctor for an antibiotic prescription.
Smartphones are now able to do on-the-spot diagnostic tests that were previously only able to be performed in a lab.
No longer. Koh, who works for Scanwell Health, was instrumental in the development of the company's smartphone app that is FDA-cleared for urinary tract infection screening. It allows someone to test urine at home using a paper test strip — the same one used by doctors in ERs and labs. The phone app reads a scan card from the test kit that can analyze what's on the strip and then connect the patient to a physician who can make a virtual diagnosis.
Test strips cost $15 for a three-pack and consultation with a doc is about the same as an average co-pay -- $25, and the app matches the quality of clinical laboratory tests, according to the company. Right now, you can get a referral to a telehealth visit with a doctor in California and get a prescription. A national rollout is in the works within the next couple of months.
"It's so easy to use them at home and eliminate the inefficiencies in the process," says Koh. "A telemedicine doctor can look at the test results and prescribe directly to the pharmacy instead of women waiting at home, miserable, and crying in the bathtub."
Scanwell is now involved in an ongoing National Institutes of Health- sponsored study of chronic kidney disease to test a version of the app to identify patients who have the disease, which affects more than 30 million Americans. "Because kidney disease has virtually no symptoms, by the time people realize they're sick, their illness is advanced and they're ready for dialysis," says Koh. "If we can catch it sooner, early intervention can help them avoid kidney failure."
Smartphones have changed society — and now they may change medical care, too. Thanks to the incredible processing capabilities of our smartphones, which come equipped with a camera, access to the internet and are thousands of times faster than the 1960s era NASA computers that ran the Apollo Moon Mission, these pocket-sized powerhouses have become an invaluable tool for managing our health and are even able to do on-the-spot diagnostic tests that were previously only able to be performed in a lab.
This shift to in-home testing is the wave of the future, promising to ease some of the medical care bottlenecks in which patients can have two- to three-week waits to see their family doctors and lift some of the burdens on overworked physicians.
"This is really the democratization of medicine because a lot of the things we used to rely on doctors, hospitals, or labs to do we'll be able to do ourselves," says Dr. Eric Topol, an eminent cardiologist and digital health pioneer at the Scripps Clinic and Research Institute in La Jolla.
But troubling questions remain. Aside from the obvious convenience, are these tests truly as accurate as ones in a doctor's office? And with all this medical information stored and collected by smartphones, will privacy be sacrificed? Will friends, family members, and employers suddenly have access to personal medical information we'd rather keep to ourselves?
The range of what these DIY health care apps can do is mind-boggling, and even more complex tests are on the way.
"I'm really worried about that because we've let our guard down," says Topol. "Data stored on servers is a target for cyber thieves — and data is being breached, hacked, brokered, and sold, and we're complacent."
Still, the apps have come a long way since 2011 when Topol whipped out an experimental smartphone electro-cardiogram that he had been testing on his patients when a fellow passenger on a flight from Washington D.C. was seized with severe chest pains. At 35,000 feet in the air, the app, which uses fingertip sensors to detect heart rate, showed the man was having a heart attack. After an emergency landing, the passenger was rushed to the closest hospital and survived. These days, even the Apple Watch has an FDA-approved app that can monitor your electro-cardiogram readings.
The range of what these DIY health care apps can do is mind-boggling, and even more complex tests are on the way. Phone apps can now monitor sleep quality to detect sleep apnea, blood pressure, weight and temperature. In the future, rapid diagnostic tests for infectious diseases, like flu, Dengue or Zika, and urinalysis will become common.
"There is virtually no limit to the kinds of testing that can be done using a smartphone," says Dr. John Halamka, Executive Director of the Health Technology Exploration Center at Beth Israel Lahey Health. "No one wants to drive to a clinician's office or lab if that same quality testing can be achieved at a lower cost without leaving home."
SkinVision's skin cancer screening tool, for instance, can tell if a suspicious mole is cancerous. Users take three photos, which are then run through the app's algorithm that compares their lesions with more than three million pictures, evaluating such elements as asymmetry, color, and shape, and spits out an assessment within thirty seconds. A team of in-house experts provide a review regardless of whether the mole is high or low risk, and the app encourages users to see their doctors. The Dutch-based company's app has been used by more than a million people globally in the EU, and in New Zealand and Australia, where skin cancer is rampant and early detection can save lives. The company has plans to enter the U.S. market, according to a spokesperson.
Apps like Instant Heart Rate analyze blood flow, which can indicate whether your heart is functioning normally, while uChek examines urine samples for up to 10 markers for conditions like diabetes and urinary tract infections. Some behavioral apps even have sensors that can spot suicide risks if users are less active, indicating they may be suffering from a bout of the blues.
Even more complex tests are in the research pipeline. Apps like ResAppDX could eventually replace x-rays, CT scans, and blood tests in diagnosing severe respiratory infections in kids, while an EU-funded project called i-Prognosis can track a variety of clues — voice changes, facial expressions, hand steadiness — that indicate the onset of Parkinson's disease.
These hand-held testing devices can be especially helpful in developing countries, and there are pilot programs to use smartphone technology to diagnose malaria and HIV infections in remote outposts in Africa.
"In a lot of these places, there's no infrastructure but everyone has a smartphone," says Scanwell's Koh. "We need to leverage the smartphone in a clinically relevant way."
However, patient privacy is an ongoing concern. A 2019 review in the Journal of the American Medical Association conducted by Australian and American researchers looked at three dozen behavioral health apps, mainly for depression and smoking cessation. They found that about 70 percent shared data with third parties, like Facebook and Google, but only one third of them disclosed this in a privacy policy.
"Patients just blindly accept the end user agreements without understanding the implications."
Users need to be vigilant, too. "Patients just blindly accept the end user agreements without understanding the implications," says Hamalka, who is also the Chief Information Officer and Dean for Technology at Harvard Medical School.
And quality control is an issue. Right now, the diagnostic tools currently available have been vetted by the FDA, and overseas companies like Skin Vision have been scrutinized by the U.K.'s National Health Service and the EU. But the danger is that a lot of apps are going to be popping up soon that haven't been properly tested, due to loopholes in the regulations.
"All we want," says Topol, "are rigorous studies to make sure what consumers are using is validated."
[Correction, August 19th, 2019: An earlier version of this story misstated the specifics of SkinVision's service. A team of in-house experts reviews users' submissions, not in-house dermatologists, and the service is not free.]
MILESTONE: Doctors have transplanted a pig organ into a human for the first time in history
Surgeons at Massachusetts General Hospital made history last week when they successfully transplanted a pig kidney into a human patient for the first time ever.
The recipient was a 62-year-old man named Richard Slayman who had been living with end-stage kidney disease caused by diabetes. While Slayman had received a kidney transplant in 2018 from a human donor, his diabetes ultimately caused the kidney to fail less than five years after the transplant. Slayman had undergone dialysis ever since—a procedure that uses an artificial kidney to remove waste products from a person’s blood when the kidneys are unable to—but the dialysis frequently caused blood clots and other complications that landed him in the hospital multiple times.
As a last resort, Slayman’s kidney specialist suggested a transplant using a pig kidney provided by eGenesis, a pharmaceutical company based in Cambridge, Mass. The highly experimental surgery was made possible with the Food and Drug Administration’s “compassionate use” initiative, which allows patients with life-threatening medical conditions access to experimental treatments.
The new frontier of organ donation
Like Slayman, more than 100,000 people are currently on the national organ transplant waiting list, and roughly 17 people die every day waiting for an available organ. To make up for the shortage of human organs, scientists have been experimenting for the past several decades with using organs from animals such as pigs—a new field of medicine known as xenotransplantation. But putting an animal organ into a human body is much more complicated than it might appear, experts say.
“The human immune system reacts incredibly violently to a pig organ, much more so than a human organ,” said Dr. Joren Madsen, director of the Mass General Transplant Center. Even with immunosuppressant drugs that suppress the body’s ability to reject the transplant organ, Madsen said, a human body would reject an animal organ “within minutes.”
So scientists have had to use gene-editing technology to change the animal organs so that they would work inside a human body. The pig kidney in Slayman’s surgery, for instance, had been genetically altered using CRISPR-Cas9 technology to remove harmful pig genes and add human ones. The kidney was also edited to remove pig viruses that could potentially infect a human after transplant.
With CRISPR technology, scientists have been able to prove that interspecies organ transplants are not only possible, but may be able to successfully work long term, too. In the past several years, scientists were able to transplant a pig kidney into a monkey and have the monkey survive for more than two years. More recently, doctors have transplanted pig hearts into human beings—though each recipient of a pig heart only managed to live a couple of months after the transplant. In one of the patients, researchers noted evidence of a pig virus in the man’s heart that had not been identified before the surgery and could be a possible explanation for his heart failure.
So far, so good
Slayman and his medical team ultimately decided to pursue the surgery—and the risk paid off. When the pig organ started producing urine at the end of the four-hour surgery, the entire operating room erupted in applause.
Slayman is currently receiving an infusion of immunosuppressant drugs to prevent the kidney from being rejected, while his doctors monitor the kidney’s function with frequent ultrasounds. Slayman is reported to be “recovering well” at Massachusetts General Hospital and is expected to be discharged within the next several days.Niklas Anzinger is the founder of Infinita VC based in the charter city of Prospera in Honduras. Infinita focuses on a new trend of charter cities and other forms of alternative jurisdictions. Healso hosts a podcast about how to accelerate the future by unblocking “stranded technologies”.This spring he was a part of the network city experiment Zuzalu spearheaded by Ethereum founder Vitalik Buterin where a few hundred invited guests from the spheres of longevity, biotechnology, crypto, artificial intelligence and investment came together to form a two-monthlong community. It has been described as the world’s first pop-up city. Every morning Vitalians would descend on a long breakfast—the menu had been carefully designed by famed radical longevity self-experimenter Bryan Johnson—and there is where I first met Anzinger who told me about Prospera. Intrigued to say the least, I caught up with him later the same week and the following is a record of our conversation.
Q. We are sitting here in the so-called pop-up network state Zuzalu temporarily realized in the village of Lusticia Bay by the beautiful Mediterranean Sea. To me this is an entirely new concept: What is a network state?
A. A network state is a highly aligned online community that has a level of in-person civility; it crowd-funds territory, and it eventually seeks diplomatic recognition. In a way it's about starting a new country. The term was coined by the crypto influencer and former CTO of Coinbase Balaji Srinivasan in a book by the same title last year [2022]. What many people don't know is that it is a more recent addition or innovation in a space called competitive governance. The idea is that you have multiple jurisdictions competing to provide you services as a customer. When you have competition among governments or government service providers, these entities are forced to provide you with a better service instead of the often worse service at higher prices or higher taxes that we're currently getting. The idea went from seasteading, which was hardly feasible because of costs, to charter cities getting public/private partnerships with existing governments and a level of legal autonomy, to special economic zones, to now network states.
Q. How do network states compare to charter cities and similar jurisdictions?
A. Charter cities and special economic zones were legal forks from other existing states. Dubai, Shenzhen in China, to some degree Hong Kong, to some degree Singapore are some examples. There's a host of other charter cities, one of which I'm based in myself, which is Prospera located in Honduras on the island Roatán. Charter cities provide the full stack of governance; they provide new laws and regulations, business registration, tax codes and governance services, Estonia style: you log on to the government platform and you get services as a citizen.
When conceptualizing network states, Balagi Srinivasan turns the idea of a charter city a bit on its head: he doesn't want to start with this full stack because it's still very hard to get these kinds of partnerships with government. It's very expensive and requires lots of experience and lots of social capital. He is saying that network states could instead start as an online community. They could have a level of alignment where they trade with each other; they have their own economy; they meet in person in regular gatherings like we're doing here in Zuzulu for two months, and then they negotiate with existing governments or host cities to get a certain degree of legal autonomy that is centered around a moral innovation. So, his idea is: don't focus on building a completely new country or city; focus on a moral innovation.
Q. What would be an example of such a moral innovation?
A. An example would be longevity—life is good; death is bad—let's see what we can do to foster progress around that moral innovation and see how we can get legal forks from the existing system that allow us to accelerate progress in that area. There is an increasing realization in the science that there are hallmarks of aging and that aging is a cause of other diseases like cancer, ALS or Alzheimer's. But aging is not recognized as a disease by the FDA in the United States and in most countries around the world, so it's very hard to get scientific funding for biotechnology that would attack the hallmarks of aging and allow us potentially to reverse aging and extend life. This is a significant shortcoming of existing government systems that groups such as the ones that have come together here in Montenegro are now seeking alternatives too. Charter cities and now network states are such alternatives.
Q. Would it not be better to work within the current systems, and try to improve them, rather than abandon them for new experimental jurisdictions?
A. There are numerous failures of public policies. These failures are hard, if not impossible, to reverse, because as soon as you have these policies, you have entrenched interests who benefit from the regulations. The only way to disrupt incumbent industries is with start-ups, but the way the system is set up makes it excessively hard for such start-ups to become big companies. In fact, larger companies are weaponizing the legal system against small companies, because they can afford the lawyers and the fixed cost of compliance.
I don't believe that our institutions in many developed countries are beyond hope. I just think it's easier to change them if you could point at successful examples. ‘Hey, this country or this zone is already doing it very successfully’; if they can extend people’s lifespan by 10 years, if they can reduce maternal mortality, and if they have a massive medical tourism where people come back healthier, then that is just very embarrassing for the FDA.
Q. Perhaps a comparison here would be the relationship between Hong Kong and China?
A. Correct, so having Hong Kong right in front of your door … ‘Hey, this capitalism thing seems to work, why don't we try it here?’ It was due to the very bold leadership by Deng Xiaoping that they experimented with it in the development zone of Shenzhen. It worked really well and then they expanded with more special economic zones that also worked.
Próspera is a private city and special economic zone on the island of Roatán in the Central American state of Honduras.
Q. Tell us about Prospera, the charter city in Honduras, that you are intimately connected with.
A. Honduras is a very poor country. It has a lot of crime, never had a single VC investment, and has a GDP per capita of 2,000 per year. Honduras has suffered tremendously. The goal of these special economic zones is to bring in economic development. That's their sole purpose. It's a homegrown innovation from Honduras that started in 2009 with a very forward-thinking statesman, Octavio Sanchez, who was the chief of staff to the president of Honduras, and then president. He had his own ideas about making Honduras a more decentralized system, where more of the power lies in the municipalities.
Inspired by the ideas of Nobel laureate economist Paul Romer, who gave a famous Ted Talk in 2009 about charter cities, Sanchez initiated a process that lasted for years and eventually led to the creation of a special economic zone legal regime that’s anchored in the Hunduran constitution that provides the highest legal autonomy in the world to these zones. There are today three special economic zones approved by the Honduran government: Prospera, Ciudad Morazan and Orchidea.
Q. How did you become interested and then involved in Prospera?
A. I read about it first in an article by Scott Alexander, a famous rationalist blogger, who wrote a very long article about Prospera, and I thought, this is amazing! Then I came to Prospera and I found it to be one of the most if not the most exciting project in the world going on right now and that it also opened my heart to the country and its people. Most of my friends there are Honduran, they have been working on this for 10 or more years. They want to remake Honduras and put it on the map as the place in the world where this legal and governance innovation started.
Q. To what extent is Prospera autonomous relative to the Honduran government?
A. What's interesting about the Honduran model is that it's anchored within the Honduran constitution, and it has a very clear framework for what's possible and what's not possible, and what's possible ensures the highest degree of legal autonomy anywhere seen in the world. Prospera has really pushed the model furthest in creating a common law-based polycentric legal system. The idea is that you don't have a legislature, instead you have common law and it's based on the best practice common law principles that a legal scholar named Tom W. Bell created.
One of the core ideas is that as a business you're not obligated to follow one regulatory monopoly like the FDA. You have regulatory flexibility so you can choose what you're regulated under. So, you can say: ‘if I do a medical clinic, I do it under Norwegian law here’. And you even have the possibility to amend it a bit. You're still required to have liability insurance, and have to agree to binding arbitration in case there's a legal dispute. And your insurance has to approve you. So, under that model the insurance becomes the regulator and they regulate through prices. The limiting factor is criminal law; Honduran criminal law fully applies. So does immigration law. And we pay taxes.
Q. Is there also an idea of creating a kind of healthy living there, and encourage medical tourism?
A. Yes, we specifically look for legal advantages in autonomy around creating new drugs, doing clinical trials, doing self-medication and experimentation. There is a stem cell clinic here and they're doing clinical trials. The island of Roatán is very easily accessible for American tourists. It's a beautiful island, and it's for regulatory reasons hard to do stem cell therapies in the United States, so they're flying in patients from the United States. Most of them are very savvy and often have PhDs in biotech and are able to assess the risk for themselves of taking drugs and doing clinical trials. We're also going to get a wellness center, and there have been ideas around establishing a peptide clinic and a compound pharmacy and things like that. We are developing a healthcare ecosystem.
Q. This kind of experimental tourism raises some ethical issues. What happens if patients are harmed? And what are the moral implications for society of these new treatments?
A. As a moral principle we believe in medical freedom: people have rights over their bodies, even at the (informed) risk of harm to themselves if no unconsenting third-parties are harmed; this is a fundamental right currently not protected effectively.
What we do differently is not changing ethical norms around safety and efficacy, we’re just changing the institutional setup. Instead of one centralized bureaucracy, like the FDA, we have regulatory pluralism that allows different providers of safety and efficacy to compete under market rules. Like under any legal system, common law in Prospera punishes malpractice, fraud, murder etc. This system will still produce safe and effective drugs, and it will still work with common sense legal notions like informed consent and liability for harm. There are regulations for medical practice, there is liability insurance and things like that. It will just do so more efficiently than the current way of doing things (unless it won’t, in which case it will change and evolve – or fail).
A direct moral benefit ´to what we do is that we increase accessibility. Typical gene therapies on the market cost $1 million dollars in the US. The gene therapy developed in Prospera costs $25,000. As to concern about whether such treatments are problematic, we do not share this perspective. We are for advancing science responsibly and we believe that both individuals and society stand to gain from improving the resiliency of the human body through advanced biotechnology.
Q. How does Prospera relate to the local Honduran population?
A. I think it's very important that our projects deliver local benefits and that they're well anchored in local communities. Because when you go to a new place, you're seen as a foreigner, and you're seen as potentially a danger or a threat. The most important thing for Prospera and Ciudad Morazan is to show we're creating jobs; we're creating employment; we're improving people's lives on the ground. Prospera is directly and indirectly employing 1,100 people. More than 2/3 of the people who are working for Prospera are Honduran. It has a lot of local service workers from the island, and it has educated Hondurans from the mainland for whom it's an alternative to going to the United States.
Q. What makes a good Prosperian citizen?
A. People in Prospera are very entrepreneurial. They're opening companies on a small scale. For example, Vehinia, who is the cook in the kitchen at Prospera, she's from the neighboring village and she started an NGO that is now funding a school where children from the local village can go to instead of a school that's 45 minutes away. There's very much a spirit of ‘let's exchange and trade with each other’. Some people might see that as a bit too commercial, but that's something about the culture that people accept and that people see as a good thing.
Q. Five years from now, if everything goes well, what do we see in Prospera?
A. I think Prospera will have at least 10,000 residents and I think Honduras hopefully will have more zones. There could be zones with a thriving industrial sector and sort of a labor-intensive economy and some that are very strong in pharmaceuticals, there could also be other zones for synthetic biology, and other zones focused on agriculture. The zones of Prospera, Ciudad Morazan and Orchidea are already showing the results we want to see, the results that we will eventually be measured by, and I'm tremendously excited about Honduras.