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The FDA isn’t tech’s biggest hurdle to the healthcare system

October 31, 2018

From wearables to embeddable health status sensors, the abundance of consumer-friendly health tech is now changing how physicians and patients interact.

The impact of health tech is even shifting health insurer mindsets, from actuaries to patient advocates, as they seek to have products consumers share greater responsibility for their care, incentivizing them with reduced costs.

But as the convergence of medicine and technology transforms the physician-payer-patient relationship, innovators who believe their hardware and software may solve problems are very often unable to find a decision-making champion in the health system. Often consumed with their technology, innovators forget—or don’t know—they must integrate their ideas into a very fragmented US healthcare system go to Many fail to secure buy-in.

Chaotic dynamic

The fragmentation starts on the reimbursement front, where insurance industry players are largely siloed from each other—there are few universal policies. HCPs are much the same, with each hospital and physician group having its own gatekeepers and rightly cautious group of providers to convince. And underlying it all is a patchwork of legacy informatics and EMRs that struggle to talk to each other.

Those conditions lead to an unpredictable, often chaotic, dynamic for health tech, one that impedes progress toward consumerizing the healthcare experience. And this remains the biggest challenge for Big Tech and startups alike as they seek to bring much-needed change to the health ecosystem.

Take Apple’s recent team up with telemedicine vendor American Well and remote cardiac monitoring innovator BioTelemetry to test how the Apple Watch might detect irregular heartbeats. Apple’s collaboration with these health companies helped facilitate FDA clearance of the Apple Watch for personal electrocardiogram screening. Early diagnosis of arrhythmias may prevent stroke, save lives, and reduce costs. So, what’s the hang up?

For one, there’s a lack of evidence to justify mass screening of atrial fibrillation. Doctors poo-poo the new heart monitor offering for other reasonsWho is responsible for accuracy and engaging patients with arrythmias? What happens if a patient has a stroke? Will there be an inordinate amount of false positives?

FDA Commissioner Scott Gottlieb may have championed the agency’s new pre-certification program for digital health, of which Apple is a charter member, but the commissioner doesn’t have direct voice over the payer system or provider behavior. FDA regulates the drug and health technology approval process—not whether physicians and payers will encourage patients to use these advances, however easy they may be to apply. Find more useful source about the health care here.

And, while the fee-for-service coverage model may slowly be giving way to the value-based care structure, we’re not there yet. In other words, Apple may be developing great tech, but we’re still living in a fee-for-service system. And, where doctors face the “seven-minute per patient rule,” questions on syncing the Apple Watch or what to look for become distractions.

Embrace the chaos and the health ecosystem

It’s easy to be intimidated by such inherent complexities, including navigating federal regulations, government and association policies, litigation risk, physician-patient relationships, data privacy, device security, and ownership of patients’ health information.

But to improve people’s’ lives, we need the tech world to learn how to navigate the health ecosystem and for health professionals to transcend anxiety and recognize that change first creates chaos before systems normalize.

As tech streamlines the care process and data link patients to HCPs, innovators need to better understand the varying perspectives and motivations of decision makers within the health ecosystem to improve health, reduce cost and streamline the care-delivery supply chain overall.

Indeed, health tech holds the power to connect our nation’s fragmented health ecosystem and knit patients, providers, and payers more closely together. Suddenly, data, accountability, and cost are coming together.

Engineers and economists recognize the value of this shift. Now, it’s time for marketers and communicators to support the people on the frontlines of care—patients, physicians, and payers. Who is responsible for making that happen? Everyone.

Tech companies—often founded by engineers and software designers—have begun to partner with healthcare experts adept at navigating complexities surrounding health economics—from innovation development to guidelines to reimbursement.

Tech wizards are recognizing that, along with being change agents, they must demonstrate how their “gee-wiz” contributions improve care, reduce cost, advance innovation, and impact quality of life, wellness, and longevity. For that, they need their health counterparts to help them travel through the fragmented system and connect decision-maker dots. Find here best English courses.

While doctors may fret over incorporating digital health into their patient practice, about how data can be interpreted, or even about how they will be reimbursed, there is no turning back.

In fact, the aforementioned challenges are only the beginning. The fusion of medicine and technology will force many more the locksmith boss. Are physicians qualified to “prescribe” technology? How will they learn the difference between what’s right for their patient’s ’ health and what’s just a techie fad? Who is responsible for educating the next generation of health professionals on integrating health and health tech?

These are important questions that must be answered. They are not unscalable walls toward implementing technology’s nascent role in keeping tabs on patients with health urgencies.

Health tech is a form of democratization in patient care—it creates parity among the players. Despite the challenges, healthcare marketers are best suited to pioneer how pharma and digital health are allies to therapeutic innovation.

Michael Heinley is a Partner with Finn Partners.
First published on MM&M on 24 October 2018.


TAGS: Healthcare/HealthTech