Healthcare Innovation is Evolutionary

What we presume to be continuous is often discrete.

Something Paleontologist Stephen J. Gould came to find in his studies of evolutionary biology. He noted that most evolution is characterized by long periods of stability and only infrequently punctuated by swift periods of rapid evolutionary change and new species formation. This idea contrasted the then widely held notion that evolutionary change is characterized by a pattern of continuous, ongoing change, which is what many presumed based upon the fossil records available at that time.

Subsequent fossil records discovered afterwards have proven Gould right – that evolution, once thought to be continuous, is fundamentally discrete, with well defined periods of stasis and periods of rapid change.

This particular pattern of evolution not only defines how life changes on earth, but also how healthcare advances into the future – through rapid periods of change punctuated by periods of stasis – though you may not think that, given the seemingly incessant, rapid influx of venture capital into healthcare start-ups.

When you follow the funding trends in early stage healthcare startups, you would inevitably assume that the pandemic merely accelerated an ongoing, upward trend of investments in healthcare digital startups. After all, most of the data presumes as much. If anything, it seems that the pandemic was merely building upon a preexisting trend.

But many of the patterns that appeared over the course of the pandemic may prove short term aberrations rather than meaningful changes in healthcare. Yet differentiating between pandemic driven trends and short term aberrations can be quite confusing.

In a peer reviewed article published in late 2020, Dr. Sadiq Patel found that during the pandemic, 30.1% of all visits were provided by telemedicine, which substantiated a well-documented, exponential increase from pre-pandemic levels. Though the percentages varied across the country and by specialty, the growth was undeniable.

But within recent weeks, many large insurance plans have found mixed benefits with telemedicine. In a recent Healthcare Investing Trends Report by HIMSS (Healthcare Information and Management Systems Society), prominent healthcare private equity investors – those who invest in more mature healthcare companies – envision a different future for telemedicine, one that blends telemedicine with traditional in-person visits, and integrates seamless triaging and referrals between remote and in-person care.

This means the change many investors believe will come to pass is not necessarily in the technology, but in the interaction between the patient and the technology. And in a heavily regulated industry like healthcare, the regulations often define the interactions that take place with the patient. Which means the future of telemedicine is less dependent upon technology, and more upon the regulatory changes that would foster more digital interactions with patients.

A sentiment echoed by Dr. Katherine Dallow, Vice President of Clinical Programs and Strategy at Blue Cross Blue Shield of Massachusetts, who in a recent interview with USA Today said:

“A lot of people had wanted to bridge the gap between technology and provision of health care long before the pandemic. What happened with COVID, for better or worse, was the entire industry was freed up from all the regulatory issues that had been a barrier to people accessing virtual care.”

Implying that changes in regulatory policy define the discrete events between periods of change and periods of stasis in healthcare innovation – which, when applied to the pandemic, can differentiate between pandemic drive trends and short term aberrations.

As evolution is not just change, but change that successfully adapts. Healthcare innovations that either began or accelerated during the pandemic must now prove they can successfully adapt to the post-pandemic world of healthcare – not only changing with the pandemic, but successfully adapting post-pandemic.

Something that is not immediately discernible through the trends in healthcare investments. The pandemic has increased demand for digital health solutions, especially for access to care technology like telemedicine. According to Rock Health, a digital health incubator based out of San Francisco, funding for digital health startups nearly doubled from $7.5 billion in 2019 to $14.1 billion in 2020. Moreover, StartUp Health, a prominent healthcare crowd-funding platform, reported that health innovation funding increased 55% from 2019 to 2020.

But funding does not characterize a successful startup, which can be defined broadly as the ability to grow sustainability, impact patient care meaningfully, and above all, create an exit – a sale to a larger company or initiate a public offering on financial markets – which are the two main mechanisms through which startup investors make their money.

But in healthcare, most exits come from acquisitions, or sales transactions in which the startup is sold to a large corporation. In a 2020 report by Angel Capital Association, only 4% of all medical and healthcare technologies were likely to exit via a public offering and become a standalone company, whereas 18% were likely to be sold to a larger, more established company – with the remaining companies failing – indicating that most innovations in healthcare eventually merge into larger companies, becoming one of many offerings by companies well versed with the current healthcare market.

Large companies have resources and capabilities well beyond any startup, and the most likely situation in which a large company would acquire a startup is when a new market opportunity emerges – which usually only emerges when regulatory changes appear.

So while the increase in funding is undoubtedly captivating, and the pandemic driven influx of venture capital funding seems to portend many positive changes in healthcare, only those startups that can successfully navigate changes in the regulatory landscape can become successful – truly able to adapt to a post-pandemic world of healthcare.

Which makes healthcare innovation evolutionary – though not the continuous, ongoing evolutionary trend we normally presume evolution to be, but rather the rapid, discrete evolutionary trend that truly defines healthcare innovation.

In which innovation is measured not by the amount of venture capital injected into startups, but by the rate of regulatory changes that redefine basic patient interactions.

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Vaccine Passports: what we need to know

The COVID-19 pandemic has killed more than half a million people in the US and has seriously impacted our daily lives. The granting of Emergency Use Authorizations for COVID-19 vaccines has been a game changer in helping to reverse the pandemic onslaught. Demand for the vaccines currently far exceeds supply nationwide. They have become the golden ticket that can transport us back to a time when routine activities, such as attending school or taking vacations, didn’t seem fraught with danger. What’s the best way to go about re-establishing these activities? One idea that’s getting discussed seriously is giving those who have been immunized a vaccination passport (VP).

What is a vaccination passport?

Let’s start by clarifying some terminology. VPs are documents that show that someone has been given a vaccine(s) and is therefore presumed to be immune from getting and sharing that disease. These are distinct from diagnostic tests to determine if a person is or is not infected with a particular virus (PCR and viral antigen tests) or has been exposed to a virus (antibody tests). VPs are the modern day equivalents of the “letters of transit” that played a key role in the film Casablanca. They’ll enable you to travel freely.

Why give vaccine passports?

Vaccinated people are unlikely to transmit the virus that causes COVID-19 with others, though this has yet to be definitely proven. So, what’s the primary rationale for giving vaccination passports? It seems the goal is to incentivize people to get vaccinated. Folks might be more likely to seek out the vaccine if it bestows upon them certain privileges, such as being able to travel freely. While the idea might sound appealing at one level, the road to vaccine passports is pockmarked with political potholes and littered with logistical land mines.

Administrative issues

There are a lot of important questions that need to be answered before VPs can become widespread; it’s unlikely there will be a “one size fits all” solution. What might VPs look like? Pieces of paper (that could easily be lost or counterfeited), or a digital key or document you store on your smartphone (that many older folks still don’t have)? If you lost one, how would you get it replaced? Would your vaccination records be tied to your other medical records, and if so, what kind of privacy and security protections would be needed to safeguard your data? How would the passport administrator verify that you got vaccinated in the first place? Who is responsible for correcting any errors that crop up? Given how much we’ve struggled as a nation to simply solve the scheduling of vaccinations, VPs might be significantly more difficult to manage.

Who’s going to run the program?

A coalition of health tech leaders (including Epic, the Mayo Clinic, Microsoft and Salesforce) has started the Vaccination Credential Initiative to create an internationally accepted digital health card. Its vision – as stated on its website – is “to empower individuals to obtain an encrypted digital copy of their immunization credentials to store in a digital wallet of their choice. Those without smartphones could receive paper printed with QR codes containing World Wide Web Consortium (W3C) verifiable credentials.” Some European countries (e.g. Denmark) are working on developing their own immunization passports, and the President of the European Union Commission has voiced support for them.

We already have a hodgepodge system designed to keep folks with COVID-19 from traveling. Many airlines are requiring proof of non-infectivity to board a plane – these are distinct from VPs. The methods adopted vary from airline to airline: United uses Travel Ready Center, American uses VeriFly while others use Common Pass. Saga cruises are the first in the UK to demand proof of vaccination, but not everyone is on board with the concept. The World Travel and Tourism Council stated its opposition to allowing travel only by those who have been vaccinated, on the grounds that it is discriminatory.

Discrimination concerns

The concept of gaining advantage from one’s immunological status is not a new one. In New Orleans in the mid 19th century, great economic value was attached to those who survived the onslaught of epidemic waves of yellow fever. A mix of structural racism and a system valuing “immunocapital” ranked men and women highly if they were yellow fever survivors. Those that had not had the disease yet found it difficult to obtain work or obtain credit and women could not marry. Slaves were similarly revalued, with larger assessments attached to survivors. This legacy of viral discrimination casts a long shadow over current discussions surrounding vaccination passports.

Also problematic is the fact that not everyone will be eligible for VPs. Some people can’t be vaccinated for medical reasons but would still like to participate in whatever activities the passports enable (such as travel opportunities). These individuals will likely file complaints if they are denied VPs, arguing that they’re discriminatory in nature. Vaccine opponents will no doubt also file lawsuits seeking to block the use of VPs, claiming they represent an attack on their freedoms and personal choice.

Others may be shut out of VP programs because they don’t have the computer skills to register online, a problem that’s turned out to be widespread with the vaccinations. Don’t have any ID? In some places this prevents the most vulnerable from getting the COVID-19 vaccine, and therefore VPs as well. Many Black and marginalized communities are already deeply suspicious of the medical establishment, and wary of receiving a COVID-19 vaccine. Restrictions that prevent these groups from participating in various societal activities because they don’t have VPs will echo the Jim Crow days of poll taxes and literacy tests that were required to vote.

Enforcement issues

VPs bring up a similar issue as mask mandates: who is going to enforce them? It is one thing for a cruise line to do so, since reservations are required and extensive paperwork needs to be filled out in advance. Who is going to keep non-vaccinated people out of restaurants or concerts that require proof of vaccination? We’ve already seen anti-maskers storm department stores, ignore requirements to wear masks on planes and even kill a security guard who confronted them.

Black market for vaccine passports

Many airlines are now requiring proof of a negative COVID-19 test before they will let their customers fly. This has led to a black market for fake negative COVID-19 test results for those who are looking to game the system. Similarly, bogus cards claiming that the cardholder was exempt– for medical reasons – from having to wear a mask, have been manufactured and distributed. It’s not hard to imagine that a similar market will emerge for VPs.

Overcoming vaccine hesitancy

Given the multitude of issues and concerns listed above, moving forward with issuing vaccination passports seems highly problematic. If the primary purpose of having VPs is to drive up immunization rates, that can be better accomplished by running public service announcements and ads illustrating how liberating it is to start doing normal activities once vaccinated. A nationwide campaign to do just that is already in the works. I personally can think of a better use for the time and money that will be spent on establishing VPs: use them to focus efforts on overcoming vaccine hesitancy in concert with combatting the high tide of online vaccine misinformation and disinformation.

Source: Technology Networks

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