Developing innovative health technologies is very important because they can extend human life by broadening the scope of medicine, improve the quality of life for patients, and provide an opportunity to foster new industries.

New health technologies can help Korea advance in healthcare services and ICT utilization, develop precision medicine, and pioneer a new medical field.

Innovative health technologies have a significant industrial impact because they can help Korea avoid competition with medically advanced countries and find a niche market.

However, for innovative medical technologies to be used in clinical settings, they need to obtain the regulatory nod and health insurance benefits. Reimbursement is allowed only for those that prove both safety and effectiveness.

However, it isn't easy to prove the cost-effectiveness of innovative health technology in a short time.

The bigger problem is that Korea’s single national health insurance program makes it more difficult for developers to present evidence using innovative health technology. As a result, the developer has to overcome many obstacles.

In this sense, the recently introduced New Health Technology Assessment (nHTA) system is a step forward for Korean healthcare. The system allows innovative health technology to be used early for patient care if it meets certain requirements in innovativeness and potential.

How to apply innovative health technology to clinical care is an issue for Korea and many other countries. The U.S. gives conditional insurance benefits such as “coverage with evidence development” (CED) for research that creates evidence for determining whether public insurance rates are covered, as well as coverage through private insurance. The Center for Medicare and Medicaid Services (CMS), which determines the reimbursement rates in the U.S., helps people check related items and circumstances on its website transparently.

Similar to Korea, Japan supports investigational new medical technologies that are not covered by public health insurance through a system called “Advanced Medicine.” This system is conditionally implemented, as each medical technology has certain standards, and only medical institutions meeting the requirement can use it. As Japan recognizes its use in combination with public health insurance, the patient pays only the cost of the advanced medicine. Other medical expenses are paid by public insurance.

Also, the U.K. has operated the Accelerated Access Review (AAR) to help patients get easy access to innovative medicine since 2014. If innovative medical technology has a low level of clinical evidence, the Clinical Commissioning Groups determines whether it should be covered by public insurance.

France ran a pilot project for percutaneous aortic valve insertion, innovative medical technology with a low level of clinical evidence in 2007, and introduced a conditional reimbursement system in 2009. Through a revision of the system in 2015, France allowed innovative health technology for patients if its clinical effect is intermediate or higher, compared to the existing technology.

These examples show that many countries are searching for ways to apply innovative health technologies to patient care quickly and safely. The key is how to present evidence for cost-effectiveness.

However, Korea’s health insurance program is conservative in granting reimbursement. So, the government finds it difficult to give even limited reimbursement to new health technology that passed the regulatory review. So, in most cases, the technology is not covered by insurance, and the patient pays the cost. In this case, the patient has to spend the money to become a trial subject with medical technology vaguely proven in effectiveness.

The doctor also faces a dilemma, finding it hard to recommend innovative medical technology aggressively to the patient. To overcome this problem, the government should support authorized innovative health technology to be used in clinical trials to provide clinical evidence.

Operating stable health insurance finance and developing innovative medical technologies using AI or 3D printing may not be compatible. In particular, using new health technology without proof of efficacy with the patient’s money could cause ethical problems and justice issues and hamper the development of innovative medical technology.

However, the government can achieve stability in health insurance spending only when it pursues many goals simultaneously as well as cost-effectiveness -- developing alternative technology, eliminating the monopoly of medical technology and inducing healthy competition, providing convenience for patients or doctors, ensuring the quality of life for patients, and establishing innovative medical technology ecosystems.

Thus, the cost for applying authorized innovative health technology to clinical care should be covered by a separate government subsidy, not by the health insurance.

One possible option is to create a special subsidy, just like the government’s subsidy for purchasing a low-emission vehicle to increase the use of electric cars. Or, the support could come as a government R&D project.

Korea introduced the nHTA system the hard way, and more technologies are passing the nHTA review. To revitalize this system and new technology, developing the technology and applying it in clinical settings should be ethical and sustainable.