We’re standing in the doorway of a healthcare revolution. Innovation policy could be the key that unlocks the future of healthcare, but sometimes it feels like a deadbolt.
It’s no secret that regulation is stifling innovation in healthcare. Innovators spend a lot of time waiting in that doorway. Especially those without the right resources and tools to move forward.
“Policy has three focal points, especially with new and emerging technologies,” said David Gray, senior manager, government relations with HIMSS. “The first is to create a regulatory environment that’s predictable to the people that are innovating, but also encourages and fosters innovation and growth with guardrails in place that protect safety.”
To do that, Gray explained, policies must be forward-looking. But there’s no foolproof way to design innovation policy for an industry that is completely unpredictable and changing at a rapid pace.
The stark reality of healthcare in the U.S. is that policy moves slowly and innovation moves rapidly. “On Capitol Hill right now, we’ve been talking a lot about telehealth as sort of a new and emerging technology. NASA has been using telehealth in some form to treat astronauts in space since the ‘60s and ‘70s. Whereas Medicare first established telehealth as a reimbursable service in 2000 and it hasn’t changed much,” Gray explained.
For those in rural or underserved communities, telehealth has been life-changing—and potentially even could be lifesaving, but traditional Medicare has invested less than 1% of its budget in it. Both innovators and policymakers understand that innovation isn’t free.
“Given the increased development cycle and need for significant initial capital, newcomers in this sector have difficulty getting enough project funding,” said Gideon Kimbrell, software engineer, entrepreneur and a member of the Forbes Technology Council. “The money must last more than two years for approval and then more time to market the project as companies try to recoup investments. By forcing entrepreneurs to invest both significant capital and years of commitment only to arrive at a pre-launch stage, this system attracts entrepreneurs who are innovating primarily for financial gain.”
There are many opposing forces and perspectives when it comes to these innovation challenges, and to design a meaningful solution, we need to understand and address all of them.
“I think it’s important to try to understand where a government agency is coming from and the policies they’re developing,” said Jeff Coughlin, senior director of government affairs at HIMSS. “Understand who the actors are within that government agency that are taking the lead on developing a particular policy. With these insights, you can determine if there is information from their background that can be helpful in shaping your approach and presentation.
"For example, are they looking at a policy through a particular lens that may or may not be most beneficial for the furtherance of your positions and ultimate goals? Trying to meet with and explain to government officials, not just high-level government officials, but the government civil servants that are implementing innovation policy is critically important,” Coughlin added.
It’s true that meaningful change cannot occur if no one has a conversation about it in the first place. Policymakers and innovators need to educate one another about their areas of expertise.
“As we’re seeing technologies come to market and be adopted at a much more rapid pace, we’re seeing a lot more outreach from the federal government trying to get that base knowledge they can use,” Gray explained. “The last thing that any federal agency wants to do is stifle innovation through bad policy or potentially kill off the next life-saving technology. But they have to do their due diligence and make sure that the technology is safe, that it’s practical; we are seeing a lot more of this outreach and this collaborative relationship.”
Watch Stephen Konya, senior innovation strategist at the Office of the National Coordinator for Health IT, talk with HIMSS TV about how the government can help startups navigate federal policies while also helping officials better understand barriers to innovation.
A common pain point for startups is that they don’t know where to start when meeting with government agencies. Besides having so many questions, they’re not always sure which agency can answer their questions.
“ONC has a lot of testing tools that developers don’t know about that they can take advantage of. We have free resources… testing tools. We just released another one called Inferno, a FHIR tool,” Stephen Konya, senior innovation strategist at the Office of the National Coordinator for Health IT (ONC), told HIMSS TV. He explained that often these new resources are announced at conferences that early-stage companies just don’t have the funding for—so they don’t always find out about them.
“[When they know] there is a set of free resources that can help them build their products and solutions, help them figure out how to get to market, help them come up with an idea of a better business plan because they understand the payment structures better or they know where the industry’s going—that’s hard to measure, but it’s certainly a big impact.”
This speaks to the need for platforms that are more accessible to both policymakers and innovators to get the information and resources they need to stay informed and connected with one another.
The challenges associated with innovation policy and regulation can have a downstream impact on both healthcare organizational strategies and consequently, the patients and communities they serve, said Rasu Shrestha, MD, MBA, executive vice president and chief strategy and transformation officer at Atrium Health and a HIMSS board member.
“The policy priorities and the monetary incentives in U.S. healthcare—as well as penalties—played a key role in the uptick of EHRs in an attempt to improve quality, safety and efficiency while bettering care coordination and exchange of information. While there is no doubt that the Health Information Technology for Economic and Clinical Health (HITECH) Act initiated a significant bump up in the adoption of EHRs, some argue that real innovation slowed down, while health systems and vendors prioritized focusing on the regulatory elements of meeting the bare requirements of meaningful use.”
Generally, health systems are more reactive than proactive when it comes to managing regulation, Dr. Shrestha noted. Closely observing both the success and struggles of health systems worldwide can help expand our understanding of innovation policy on a wider scope.
“There’s a lot happening with innovation in other healthcare systems, and even though our health system may be structured differently from other countries, there are opportunities to learn what works and what doesn’t from each other,” said Coughlin. “Other populations and other care delivery models that can be used to inform our innovation policy development and our approaches here in the U.S... I think it’s kind of a feedback loop in terms of things we do well here in the U.S., taking those innovations and figuring out what’s applicable to other approaches in global markets.”
An example of this Dr. Shrestha cites is the National Health Service (NHS) in England’s recent launch of NHSX in order to drive the digitization of healthcare across the country.
“It will leverage mutually agreed upon standards within the NHS and ensure NHS systems are interoperable with the ability to incorporate new innovation without issues. One of NHSX’s strategies is to develop an internet-like model of mutually agreed upon technology standards and local delivery.”
The Netherlands are also taking a forward-facing approach to driving global innovation, said Dr. Shrestha. By 2030, it is estimated that approximately 40% of their population will be living with chronic disease—so much of their recent work has been focused on advancing connected health and interoperability to alleviate the challenges. This led to the Netherlands earning a top spot in the Euro Health Consumer Index.
“There is clearly a groundswell of activities around innovation in healthcare, with a steady stream of support from the Ministry of Health, who have primarily been responsible for the preconditions pertaining to access, quality and cost in the health system,” explained Shrestha. “The ministry also had overall responsibility for setting priorities, and may, when necessary, introduce legislation to set strategic priorities.”
Will we continue to see ongoing efforts that will impact the pace of innovation in healthcare in the U.S.? Shrestha believes so.
“Whether in hot button issues such as ending surprise medical bills, or in longstanding issues such as interoperability, information blocking or payment reform—policy implications will continue to affect multiple elements of healthcare transformation.”
Modeling the success of others across the global health ecosystem will be key to unlocking the future of healthcare. Through learning from other countries, we can find new ways of working together, continue progressing and provide care that works for everyone, everywhere.
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Updated March 3, 2020