Looking At The Barriers To Healthcare Innovation

Timon LeDain | June 2, 2021 | 3 Min Read

Innovation in healthcare has been slow going. That's until the pandemic hit. VP of Customer Solutions at Macadamian, Timon LeDain, looks at how the pandemic has ushered in an era of transformation in this space, but LeDain also addresses the traditional barriers to healthcare innovation.

Macadamian: What are some of the biggest barriers to innovation in healthcare?

LeDain: To start, it’s a highly regulated environment. The number one barrier to innovation is regulations, which are necessary—for reasons like patient safety and privacy—but these regulations can slow down the pace of innovation. And of course, the regulatory requirements are different across different regions. We also have different types of regulations, depending on the products you’re bringing out to market.

 

Macadamian: How do rules around compliance actually help with innovation?

LeDain: There are good reasons why these regulations have come into place. We’ve seen some horrific cases of patient harm that occurred because the proper checks and balances weren’t put in place in specific healthcare systems. The thalidomide situation was a good example of that—a situation where the medication was improperly tested. And there were cases of a radiation therapy machine that was not properly configured so patients were overdosed with radiation. It was situations like this that drove the regulatory requirements. But on the flip side, if you achieve the compliance hurdles faster, then you can actually speed up adoption of innovative technologies. It’s a form of third party endorsement. So, for example, if you develop an algorithm that has passed FDA approval, the adoption rate will be accelerated. Why? Because there’s that level of confidence in the maturity of that algorithm and its proven efficacy. Same goes for being certified for compliance to one of the data privacy or data security standards.

Macadamian: Talking about standards for compliance, what is HIPAA? And why does it matter?

LeDain: HIPAA stands for the Health Insurance Portability and Accountability Act, and it applies to covered entities in the United States. Traditionally, these entities are hospitals and health insurance companies. HIPAA exists to ensure that as a patient, your healthcare records can move with you, for example, if you relocate from Florida to California. HIPAA exists to ensure your health records are kept safe while being accessible to a new healthcare service provider. It sets a level of due diligence and compliance over data across all parties—both the covered entities and the third parties that support them.

 

Macadamian: What is GDPR?

LeDain: This stands for the General Data Protection Regulation, and it’s usually associated with European Union (EU) residents. Some companies might think—erroneously—that if they’re not a European company, you don’t have to worry about GDPR. But GDPR covers data for EU residents. And if you’re a company in Canada or the U.S., you still fall under those regulations if an EU resident has any personal data on one of your systems. Also, there are some measures that are similar to HIPAA, specifically relating to disclosure of patient data. But GDPR also includes some unique elements such as the right to be forgotten, where an EU resident can inquire about what data an organization has about them on file and request access to that data to correct any errors or have their data be completely wiped from the organization’s systems.

Macadamian: In the healthcare industry, patient privacy is important. How can the industry continue to innovate while also keeping patient privacy secure?

LeDain: The risk-reward measure—if it was a line in the sand—is movable, depending on the greater good of patients. But some things are immovable. Patient privacy is one of those things. Even with the modern cloud platforms that we’re now using—from Microsoft and Amazon and others—we see checks and balances in place. Even with Macadamian’s platform, HealthConnect, we’ve implemented those checks and balances from day one. We have the tools available so we can innovate quickly while still meeting the highest standards of data privacy and security. We’ve solved some of those challenges of how to innovate in the healthcare space while keeping patient privacy top of mind. There’s no cutting corners there.

 

Macadamian: How has COVID-19 sped up innovation in healthcare?

LeDain: It’s forced organizations across the world to remove barriers that are an impediment to innovation, which is necessary to get us past the pandemic. One barrier to telehealth adoption, for example, was the reimbursement model. Initially, if a clinician provided clinical advice over a phone or video conference, they couldn’t get paid for it. That’s not the case anymore. Also, COVID-19 forced us to share information on the different virus variants. That data was collected at all of the research centers around the world, including John Hopkins. Providing open access to that data to everyone working on a vaccine meant a barrier was dropped. The risk-reward equation became very clear through the pandemic. It sets us up well post-pandemic to realize that there is flexibility in terms of revisiting some of these barriers in ways that can actually accelerate advances in the healthcare space. This will benefit clinicians, patients, and the general good of society.

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