EHRs and the role of the FDA

By Wm. T. Oravecz
WTO-Associates LLC

What’s the fuss?

iHealthBeat has posted a Special Report this month headlined “Health IT Policy Committee Debates Role of FDA in Overseeing Safety of E-Health Record Systems”. Having worked in the high-tech medical device industry for many years earlier in both clinical applications science and marketing management I could not understand. Why the debate over the role the FDA has in safety in e-health record systems?

Let’s understand the charge of the FDA (Food and Drug Administration), an agency of the US Department of Health & Human Services, and how it came into existence. The FDA is responsible for protecting the public health in the United States by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products, medical devices, our nation’s food supply, cosmetics, dietary supplements, and products that give off radiation.

The FDA came into existence as the 1st comprehensive federal consumer protection law under the 1906 Food and Drugs Act, which prohibited misbranded and adulterated food and drugs in interstate commerce. However, stronger political will to effect a more significant change came in the early 1930s, spurred on by growing national outrage over some egregious examples of consumer products that poisoned, maimed, and killed many people. The tipping point came in 1937, when an untested pharmaceutical killed scores of patients, including many children, as soon as it went on the market. The enactment of the 1938 Food, Drug, and Cosmetic Act tightened controls over drugs and food, included new consumer protection against unlawful cosmetics and medical devices, and enhanced the government’s ability to enforce the law. This law, as amended, is still in force today.

I’ll never forget my first meeting and lesson about medical devices and the activities of the FDA and CDRH (Center for Devices and Radiological Health) with the Director of Regulatory Affairs for a global medical device firm. It’s not about the device or tool itself, but what the intended use (labeling) of the device or tool that determines whether we had a medical device on our hands. In one instance, we have a wooden stick. Simple enough. Now, we want to sell these “wooden sticks” as “tongue depressors” to examine the throats of patients, voilà, we have a medical device. Now, we have an obligation to demonstrate it’s safety and effectiveness before we are authorized to put this device into commerce in the United States.

What is the intended use of an EHR? Fundamentally it’s a relational database that clinicians will use to facilitate a more rapid and accurate assessment of their patients’ medical history. Saving time, money and providing a higher level of service/safety to patient care. However, if that EHR, due to some software glitch, changes the patients prescription entry by a decimal place, something very serious could be precipitated. Who do want watching your back? Your vendor alone?

Some have suggested that this sort of regulation will simply stifle innovation. As a direct witness to some of the greatest high-tech medical devices of the past 30 years such as medical linear accelerators, computerized tomography (CT), positron-emission tomography (PET) and magnetic resonance imaging (MRI), never was innovation stifled one bit by the need to demonstrate to the FDA the safety and effectiveness of those inventions. What’s the fuss?!