President Trump’s promises to reform and deregulate the FDA seem doomed to do the opposite of what they were intended to do.
His track record on other issues notwithstanding, Trump might be excused for not knowing that American medicine is a bizarro-world where the good intentions of outsiders and insiders alike transmogrify into destruction, disruption, and bureaucratic chaos.
Big Business That Depends on Regulation
In a world where insurance wasn’t a prerequisite for accessing almost any care, and the free market actually was the primary force in driving patient and provider behaviors, broad strokes deregulation might work.
But in America’s healthcare system, “access” isn’t access. Rather, having a payer on board who will cover drugs, treatment, and providers is “access.” Simply knowing that a new wonder-drug exists doesn’t help people who need it. Steamrolling the FDA so that drugmakers can offer the drug on the open market, it should come as no surprise, also helps no one in particular. Because payers–insurers–look to the FDA for evidence of a drug’s value and clinical efficacy (rather than, say, patients desperate for a cure or drugmakers looking to cash in), disrupting the approval process serves also to disrupt payer confidence.
In other words, without the FDA’s lengthy, cumbersome, and expensive approval process, payers will be shy to cover new drugs–and thereby enable patients to access them. Drugmakers, by extension, would rather not face the uncertainty of what payers, providers, and patients might decide to do with new drugs absent the structured system of insurers taking their cues from the FDA, and thereby driving the behavior of the rest of the system.
To be fair, the FDA and its system for testing and approving new medications and devices has flaws. An overreliance on drugmakers’ own data, rather than independent research, sometimes leads to a lack of rigor and poor follow-up allowing unsafe drugs and devices to slip through to market only to be proven faulty by consumers, rather than regulators. A lack of clarity in its labeling requirements creates onerous demands on manufacturers and retailers, yet provides little to no benefit to the very consumers it is supposed to help protect and inform. There is no shortage of ways in which the FDA and its operations could be improved.
But Trump’s approach to the FDA treats the organization like a Gordian knot — something more easily cut through than carefully managed — with predictably mixed and messy results. He isn’t entirely wrong that there are problems to be solved, but his approach also isn’t graceful or nuanced. More than that, though, it makes the mistake so ubiquitous in business and leadership today, of relying too much on generously vague terms like “innovation” and the amorphous power of “science” at large to provide cures not just for injury and illness, but all of society’s woes.
When Will Science Save Us
In a tech-obsessed period of American life, the instinct–apparently shared from the Trump White House on down through to developers and plenty of consumers and patients–is to rely more on automation and digital systems like EHRs to facilitate the spread of knowledge, best practices, and to capture performance and quality metrics. But overcoming both the imperfections of the FDA as well as the habits of practicing clinicians may still fall to the humans of the medical profession, rather than to their tools and tech.
Mobile technology is impacting every element of American healthcare–from insurance and billing to documentation and caregiving, the impacts are being felt. The truly transformative element of the mobile revolution is not the technology itself, or the way it changes the look and feel of the tasks it affects. Despite complaints of the depersonalizing effect of technology, the ultimate value of mobile in the sector will be how it enhances and encourages communication.
Providers are Going Mobile
Already, flexibility and functionality have already drawn providers to mobile devices and solutions. Voice-to-text technology and similar automated solutions are in the offing to relieve the documentation burden that has dampered some amount of enthusiasm toward digitization. Bolstered by these advancements, caregivers will go from subjects of their EHRs to masters of patient encounters.
One of the huge benefits of mobility — as opposed to simply being networked on desktop computers or having a digital health records solution — is the capacity for greater native customization and app development. Native apps are like the currency of the mobile, smart device world providers are entering. Developers can deliver personal, branded interfaces that allow doctors to choose precisely how they want their dashboards to look, giving their EHRs a custom touch that has been sorely lacking throughout their implementation.
App-centric development will further reduce the friction of adoption and utilization, giving doctors a sense of empowerment and investment, rather than the bland inertia that has carried digitization thus far.
The personalization of the technology through app development will help boost adoption, and return the focus to what the technology enables, rather than how it looks or what it has replaced. Mobile technology’s strength will be in reconnecting doctors and patients, and creating bridges of data and communication across the continuum of care.
Patients are Going Mobile
Patient-facing health apps and mobile point of access to care combine convenience and cost-saving with a learning curve. Increasing the visibility of EHRs through mobile portals gives patients greater reason to develop some basic health literacy, and levels the playing field during doctor encounters. The more providers use mobile solutions, the more incentive patients will have to do the same.
When apps are connected to prescription management and can monitor adherence to treatment plans, mobile devices provide a two-way mirror enabling doctor and patient to remain connected long after the encounter is over. This can allow providers to better anticipate and intervene where drug abuse is at risk, as well as to prevent ED admissions and re-admissions beyond what telehealth has been able to achieve.
Even without connecting providers, mobile health apps will also support personal health management, with an eye to prevention as well as education. From diet-planning to workout tracking and even disease management, patients have more ways than ever to study their bodies and better understand their unique wellness needs. As providers and their EHRs evolve to integrate mobile patient-generated data, the potential for customization will make each encounter more conversation-driven, using data as a platform to educate, engage, and advance communication.
All these personal, data-rich conversations will help push prevention and population health into front of mind for a generation.
When we talk about technology disrupting healthcare, we aren’t just referring to changes in the accuracy of health records or the convenience of mobile care; the real disruption comes in the form of fundamental challenges to traditional scopes of practice.
What Should We Do?
Scope of practice, broadly, is determined by a combination of liability and capability. Lead physicians carry greater liability than the bedside nurses assisting in patient care, because the care plan is directed by the lead physician. Likewise, the extra years of education and practice are assumed to increase the capacity of physicians to lead their care teams, make decisions about how the team will go about its work, and parse all of the information provided by the patient, nurses, and other specialists involved with each case.
In every other industry, productivity increases come from technology enhancing the ability of individuals and teams to perform work. Email saves time and money by improving communication; industrial robotics standardize manufacturing and raise the scale and quality of output. Every device, app, and system allows individuals to scale their contribution, to do more and add more value. Word processing and voice-to-text enable executives to do work that might otherwise have been performed by a secretary or typist. Travel websites allow consumers to find cheap tickets and travel packages that would previously have required a travel agent to acquire.
In healthcare, technology is changing the capacity of the individual caregiver, expanding what can be done, and often how well it can be done. These improvements, along with a growing need for healthcare professionals and services, are challenging traditional notions of scope of practice–for good and bad.
New Beginnings
Some of the changes to scope of practice are positive, necessary, and constructive. For example, technological literacy is necessary at every point in the care continuum, because interoperable EHRs and the vulnerability of digital information means that everyone must contribute to cyber security. In a sense, caregivers at every level must expand their scope of practice to incorporate an awareness of privacy, security, and data management considerations.
By extension, all caregivers are participating as never before in the advancement of clinical research, population health monitoring, and patient empowerment simply by working more closely with digital data and computers. As EHR technology iterates its way toward fulfilling its potential, caregivers and administrators are being forced to have difficult conversations about priorities, values, goals, and the nature of the relationship between patient, provider, system, and technology. It is overdue, and foundational to the future of healthcare.
Is There A Nurse in the House?
The trend in healthcare toward prevention and balancing patient-centered care with awareness of population health issues puts primary care in a place of greater importance than ever. This, in turn, is driving a shift in the education of nurses to promote more training, higher levels of certification, and greater specialization to justify relying on nurses to fulfill more primary care roles. They are becoming better generalists and specialists, capable of bolstering teams as well as leading them.
The advancement of diagnostic technologies and understanding of the nature of disease, illness, and genetics has also thrust the clinical laboratory into the center of healthcare. It doesn’t necessarily change the scope of practice for the laboratory scientist, but does elevate the demand and scale of operations for these professionals must fulfill. Once again, the broadening demand has dovetailed with an effort to broaden the scope of practice for other clinical roles, particularly nurses.
Whether it is appropriate or practical for nurses–already understaffed and overextended–into all these critical blended roles is open for debate.
Man, Machine and Medicine
While cross-training is valuable for improving collaboration and breaking down siloes–both critically important to the future of healthcare–it blurring the scope of practice or between roles that comprise very different skills and responsibilities. Technology is expanding the capability of every clinical and non-clinical role, but is it not entirely clear whether it is keeping up with our expectations and demand for the people in these roles.
In addition to answering these questions about scope of practice, we need to look carefully at how technology can change the scope of accountability for patients. Technology may be a platform for engagement, but getting real patient participation requires a better foundation of health literacy–just as caregivers must develop a more robust technological literacy to take advantage of EHRs.
In the age of the digital hospital and the connected patient, security will likely improve the less it depends on providers.
Everything from HIPAA to patient engagement treats physicians as the white hot sun of the healthcare universe, holding everything together and keeping it all in stable orbit. They are accountable for health outcomes, for patient satisfaction, for guiding patients to online portals, and for coordinating with care teams to keep data secure — even as mobility and EHR dominance complicates every node in the connectivity chain. All this digital chaos brings more diminished security.
Only as Strong as the Weakest Link
Every business out there has learned — usually the hard way, or by watching someone else learn the hard way — that whatever the security infrastructure, users are the weakest link. More devices means more users, and more connectivity and data-sharing means more weak spots all along the chain. By design, the EHR system adds vulnerability to healthcare data security through a long chain of users.
Patients don’t have a systemic, accountable role in all of this. Our whole approach fosters passivity on the part of the patient and paternalistic assumptions on the parts of caregivers and policymakers. We give tacit acknowledgement of this imbalance whenever malpractice law or tort reform is mentioned — and promptly left behind in the face of other, patient-exculpatory programs and initiatives.
Patients are a part of this. Clearly they are invested in their own security — the costs of health data breaches contribute to the rising costs of care, besides exposing personal financial and medical information that can carry its own universe of costs.
Patients are implicated, but they must also be accountable for security in the new high tech healthcare system.
An Old Problem with New Importance
Getting patients included in the evolution and delivery of healthcare requires engagement. The same goes for digital security. The ethical and financial dilemmas of the security situation is an expensive distraction for administrators and caregivers, but it is a learning opportunity that could empower patients. A new emphasis on digital security and privacy could be the start of a cascade of engagement with further questions of use and responsibility for outcomes.
Already, patients are key players in making telemedicine effective. Access is on the shoulders of the patients, and utilization depends on their technical literacy. The incentives–time and money savings, improved access to care–are powerful, but come with the obligation to learn the platform through which remote care is delivered. Utilizing any telehealth solutions requires patients to think about what information they want to share, whether they trust the new platform, communicating effectively with their provider, and gaining confidence for the new medium.
This same model can be applied more broadly to EHRs, and the patient role in the digital healthcare system.
Is there an unspoken fear among caregivers that the subtext of all this digital disruption is a devaluation of the human element?
In countless industries, workers and analysts alike watch the slow march of technology and innovation and see as inevitable the takeover of human tasks by robots, AI, or other smart systems. We watched as the threat of outsourcing transformed into a reality of automation in industrial sectors, saw drones take on countless new roles in the military and in commerce, and now we hear about how driverless cars, self-checkout kiosks, and even robotic cashiers in restaurants are all waiting in the wings to dive in and displace even more formerly human occupations.
And looking at how EHRs — by virtue of their cumbersome workflows alone, not to mention all the documentation and growing emphasis on analytics and records-sharing–are taking flack for burnout and frustration in hospitals across the country, it hardly seems a reach to suggest that maybe America’s caregivers are feeling not just burdened by technology, but threatened.
Digital records are already changing what doctors and nurses do, how they work, and what is expected of them — it must surely be only a matter of time before their roles start getting handed over to the robots and supercomputers … right?
Wrong.
Change, Not Replacement
While some jobs or roles may face elimination through automation, the more common effect is transformation. In healthcare, that may mean that for many their title is the same — perhaps even the education and certification standards that go along with it–but their actual functions and roles in context will be different.
We see this already with respect to EHRs. The early, primitive documentation workflows and reporting obligations have drawn ire from clinicians who see their autonomy under attack by digital bureaucracy. But this is naturally destined for correction; medicine has advanced through trial and error for centuries, and the 21st century is no different.
The transition and disruption doesn’t manifest exclusively as growing pains. Consider the role of medical laboratory scientists and technologists: the Obama administration is pushing for a cure for cancer based on the advancement of personalized medicine; patient-centered care is becoming a priority among all caregivers as well as a quality metric in health centers across the country; genomic testing is seeing growing demand on the consumer side, as well as applications in a growing array of clinical settings.
All of these trends point to the medical lab as a newly central component of the modern care center, treatment plan, and information hub. The demands all these new technologies and applications put on laboratory professionals requires them to do more learning, adapting, and leading than ever before, especially to integrate the latest and greatest devices and tests available.
Simply put, machines are still fallible, and require assistance in providing critical context, to supplement their ability to accurately read, diagnose, and self-regulate to ensure accuracy and consistency, not to mention proper application in the clinical setting.
The current plight of America’s healthcare industry is not wholly unprecedented. In fact, it isn’t even unique.
Edgar T. Wilson
American education — higher education in particular — is going through a parallel period of turmoil and scrutiny. It is really uncanny how closely the two industries actually reflect one another. Consider:
Both are critical industries whose public/private status is up for constant debate
Both serve an essentially captive market: everyone needs education to succeed in the economy, and everyone, sooner or later, will require some form of healthcare
There has been a historical tendency for both to treat the people they serve as customers, rather than as students or patients. It is more than semantics: it is a reflection of an underlying philosophy that can potentially compromise the mission of each type of institution
Both are going through a crisis of accountability, in terms of what standards are used to measure their performance, and to whom they must answer for that performance
Both have been very slow to adopt modern technology, and as a result are going through a rapid, disruptive catch-up period
In the race to modernize and reconcile many of these conflicts of purpose and identity, it appears that higher education as a whole may be slightly ahead. Because of this relative lead on the healthcare industry, behavior within the American college and university system can act as a rough preview for the health sector. So, what do we see upon gazing into this crystal ball?
All for One?
A helpful place to direct this gaze is the recent ASU GSV Summit. The name alone reveals much about what is happening in higher education, and needs to happen in healthcare: Arizona State University, in the interest of promoting innovation, collaboration, and evolution in the higher education sector, joined forces with Global Silicon Valley’s family of companies to create their joint summit.
The summit began in 2009, seven years into the tenure of ASU president Michael Crow, who has become one of the leading voices and actors in higher education’s 21st century evolution. The summit is just one of the many strategic partnerships Crow has helped organize through ASU. Aligning the school with everything from technology startups supporting the development of ASU’s online degree programs, to the Mayo Clinic Medical School to offer future doctors transdisciplinary education in fields like business or engineering, Crow is expanding the reach of America’s largest public university by strategically sharing its resources.
In American medicine, there is a clear need for a similar attitude toward strategic partnerships and mission alignment, especially with technology companies and developers. This need is most acute in terms of EHR interoperability. Despite all the rhetoric, the old mentality of siloes, competition, and proprietary ownership prevail, and information remains immobile.
This symptom has implications that extend into every other facet of healthcare.
Patrick Soon-Shiong, billionaire, surgeon and incorrigible optimist, has set his sights on curing cancer. Much like the Precision Medicine Initiative, Soon-Shiong’s approach to this challenge is a matter of getting more, better data from as many partner institutions as possible.
“Cancer is really a rare disease,” he explains. “Because of the molecular signature, because of the heterogeneity, no single institution will have enough data about any [single] cancer. So you actually need to create a collaborative overarching global connected system.”
The end result — better medicine, better outcomes — is something common to the mission of every clinical organization, and ever caregiver practicing medicine. But the means — large scale collaboration, facilitated by transparency and a suspension of select elements of competition — are seldom realized in the current environment. Reconciling the ends and the means requires organizations to think bigger than themselves, and prioritize the sort of partnerships that bring new perspectives, larger pools of data, and creative solutions where they are desperately needed.
