HITECH and the FDA’s Overhaul of Medical Device Approvals

By Kayla Matthews, HealthIT writer and technology enthusiast, Tech Blog
Twitter: @ProductiBytes

Since 1976, the U.S. Food and Drug Administration (FDA) has offered a fast-track approval process for medical device manufacturers that could prove their products were substantially similar to approved items that were already in the marketplace.

Known as 510(k), it applies to similar devices even if the technology behind them has significant differences.

When ruling about products associated with 510(k), FDA officials typically compare the physical characteristics and functionality of a new device to an existing one.

But, the FDA wants to modernize the approach basing new devices on ones no older than a decade. Additionally, the agency may publish the names of the makers and their products that are more outdated.

However, critics of the plan assert that having that 10-year cutoff limits the data produced that could be useful in proving the worthiness and safety of older medical equipment.

The FDA will establish criteria for an alternative accelerated pathway next year, and in the meantime, people wonder how the new approach could have far-reaching impacts, particularly on data and privacy as they relate to medical devices.

HITECH in a Nutshell
Barack Obama signed the HITECH (Health Information Technology for Economic and Clinical Health) Act of 2009 into law, and it spurred the adoption of electronic health records (EHR) by health professionals. A part of the Act even incentivized providers for demonstrating “meaningful use” of EHRs through 2015.

Waiting too long to adopt EHRs put organizations at risk of penalties. There are several phases of HITECH, and participating health care organizations must remain in one stage for at least two years before progressing to the next one. Also, besides affecting how patient records get captured and stored, HITECH endeavors to facilitate better sharing between relevant organizations.

Data Collection During the Device Manufacturing Process
Data from the FDA indicates that about 80 percent of medical devices that get the go-ahead each year were part of the 501(k) process and, according to Modern Medicine, almost 20 percent of those got compared to devices older than a decade.

The process for developing any new medical device — whether similar to something already on the market or not — requires collecting internal manufacturer data about the respective versions of a product. For example, companies may hire calibration specialists to tweak specific mechanical or electronic parts of their products, either on-site or by sending the devices to dedicated facilities.

Then, if there is patient data associated with the devices, manufacturers must make sure they handle it in accordance with HITECH, as well as the Health Insurance Portability and Accountability Act (HIPAA).

For starters, many innovative medical devices continually gather patient data and send it to physicians. If those products collect identifying information about users, HITECH and HIPAA likely apply to them.

Data Is Essential for Medical Device Development
Researchers argue that large bodies of post-market research are essential for assessing the safety and effectiveness of devices.

But, such information is often not gathered promptly enough now, they say. A 2015 Yale University study found only 13 percent of initiated post-market studies involving high-risk devices happened within three to five years of FDA approval.

As such, recommendations have been proposed by medical organizations that the FDA enforce the completion of post-market studies and take previously approved devices off the market if such research finds them deficient. Those suggestions came about before the FDA’s latest decision, so it’s not clear if such mandates might factor into a new fast-track approval plan.

People involved in testing medical devices bring up the need to rely on real-world evidence (RWE) when assessing patient outcomes, such as while collecting post-market data. They point out that EHRs collectively make up one of the greatest potential sources of RWE data used to evaluate medical products. As such, HITECH applies to that aspect of medical device testing.

However, EHRs are most effective for medical device testing when applicable patients stay within the same health systems. Otherwise, there’s a chance that the EHR systems may not show interoperability with each other, leaving incomplete records.

Properly Submitted Data Leads to Accurate Adverse Events Records
The FDA announced changes to its adverse events reporting system after internal research revealed facilities often didn’t follow procedures that required them to notify the organization — and device manufacturers in some cases — of problems patients experienced while using medical devices.

FDA officials haven’t mentioned if their device approval overhaul will also affect data about adverse events. But, if it does, reporting bodies will need to do while keeping HITECH in mind.

Changes on the Horizon
The news of the FDA’s intention to update its device approvals framework means relevant parties must prepare to adapt. As they do, they cannot overlook how any differences might affect how they store and share data.