Slow and steady wins the race. But does this translate to medical innovation? Should it be a sprint or more of a marathon? While medical innovation does require speed, regulators are becoming more cautious about approving truly innovative medicines and devices.
Some feel this approach leaves patients without solutions longer than necessary. Conversely, many argue that tighter control and guidelines equate to more safety and quality than ever before.
In this post, we’ll look at both sides of the argument surrounding medical innovation.
Dozens of federal and state agencies manage and regulate the health care system. Each serves a specific purpose with a unique focus. This group includes the U.S. Department of Health and Human Services, the Centers for Disease Control and Prevention, and the U.S. Food and Drug Administration — just to name a few.
As new legislation passes to protect patients’ rights and insurance, new organizations can be added to the mix. For example, the Affordable Care Act (2010) led to the creation of agencies like the Center for Medicare and Medicaid Innovation.
Adding more organizations is like adding more people in a group text. Sometimes it streamlines things, but a lot of the time it increases the complexity. Decisions involving multiple organizations can be delayed as organizations overlap on different projects. And usually, more rules are also added.
These delays in medical innovation trickle down to hospitals and health care workers, who are afraid to rock the boat with new technologies. For one, changes can be nerve-racking. Complicated systems can cause fatal human errors, resulting in patients receiving the wrong medications or wrong dosages.
Once a new system is found though, it can be an ordeal to get it vetted and approved. HIPPA, for example, demands top confidentiality around patient data. Their privacy and security standards are designed to protect patients, but they create a complicated process for adopting new systems. And even after jumping through all the hoops, it’s likely a newer, better system would already be available. Then the process would start from the top again.
What about going rogue? Well, in addition to incurring additional risk for data breaches, vigilante health care officials determined to embrace medical innovations are threatened with heavy fines.
According to Med-Tech Innovation, the fines for HIPPA violations have dramatically increased in recent years. Multi-million-dollar fines are now commonplace, coupled with legal battles that take additional time and resources.
So why would anyone want all of these regulations and government agencies involved with medical innovation? Don’t they just slow things down? In more positive news, the increased regulations lead to increased patient safety: both in terms of care and data.
FDA standards require new drugs and devices to undergo extensive testing to ensure their safety and efficacy. To be approved, they must perform at or above the performance level of existing alternatives. Logically, this makes sense — you want to be confident in a device before releasing it for public use.
And with technology advancing at rapid speed, data security has never been more important. The same Med-Tech article notes that the HIPAA Journal’s health care data breach statistics show clear trends of data breaches becoming more common. In fact, 2019 reported more breaches than any other year in recorded history. Increased compliance rules create additional safeguards, keeping sensitive patient data away from predators.
Additionally, the increase of regulators in medical innovation actually strengthens the medicines, systems, and devices being offered. New opportunities arise for cross-functional collaboration.
The medtech industry becomes more intertwined with the work of pharmaceutical companies, as they help to clarify and execute complex requirements. The end result is a better product for patient health and safety.
Despite the challenges of 2020, medical progress and developments continue.