The following is a guest blog post by Mark Muddiman, Engagement Manager at The Breakaway Group (A Xerox Company). Check out all of the blog posts in the Breakaway Thinking series.
On March 9, 2016 the Senate Committee on Health Education Labor and Pensions (HELP) approved S.1101, better known as the Medical Electronic Data Technology Enhancement for Consumers’ Health (MEDTECH) Act. As HIMSS reports, the bill aims to limit the regulatory oversight of “low-risk” medical device software, while simultaneously making a clear distinction of the FDA’s reach of authority.
But how do you define “low-risk” when it comes to a person’s health?
The answer might surprise you. These items are deemed low-risk by the MEDTECH act and will no longer require oversight:
- administrative, operational, or financial records software used in healthcare settings
- software for maintaining or encouraging a healthy lifestyle unrelated to medical treatment
- electronic patient records, excluding software for interpreting or analyzing medical image data
- software for clinical laboratory testing, excluding software for interpreting or analyzing test data
- software that provides medical recommendations and the basis for those recommendations to healthcare professionals, excluding software for acquiring, processing, or analyzing medical images or signals
Regulations serve a purpose in ensuring that the devices used do not put patients at risk, and some fear that the loosening of these restrictions could be problematic. But the number of policies vendors were previously required to abide by was staggering. There is little value in subjecting vendors or healthcare leaders to such stringent policies with software and devices that are unlikely to lead to increased risk or an adverse event. Unnecessary regulation ultimately restricts patient access to the most current technology and impedes more successful clinical outcomes.
As HIMSS further clarified, the MEDTECH act still allows the FDA to oversee medical software if it considers the product “reasonably likely to cause serious adverse consequences.” The congressional summary goes on to note that the FDA may assess a software function for safety and effectiveness if the medical device has multiple functions. For example, mobile applications do not need supervision if integrated by a vendor unless they become linked to something of medium or high risk such as medication administration. In short, vendors get the freedom they need to explore new avenues, but the FDA doesn’t cede total control and retains an option that can be interpreted broadly enough to intervene when needed. In this sense, the MEDTECH act finds a middle ground using a risk-based approach to focus oversight where it’s needed most.
Key players in the industry have supported the bill; Health IT Now and the American Medical Informatics Association (AMIA) both praised the passage of the act, while major vendors including Athenahealth, IBM, and McKesson strongly supported the push to pass the bill. Undoubtedly, the passing of the MEDTECH act was great news for vendors.
The benefits to patients and vendors are clear, but what about healthcare providers and administrators?
CIOs and CMIOs already have their hands full in keeping pace with a seemingly endless set of transformations in health IT. Now the senate is aiming to quicken innovation and promote shorter times for technology to reach the market, inevitably resulting in a faster rate at which organizations must adopt that technology. Some providers likely viewed the passage of the act with an exasperated palm to the face. The frustration is real; the move to ICD-10 occurred less than seven months ago, not to mention many organizations have implemented EHRs but are focusing on optimization to improve their ROI.
Simply put, there is no end in sight to new technologies arriving in healthcare, and there will not be a slowdown anytime soon. Healthcare organizations must proactively plan a long-term adoption strategy that accounts for continual enhancements in technology, with a focused ability to quickly bring staff to a high level of proficiency. Those that achieve such agility will be able to leverage the best technology to offer the highest standards of care.
Xerox is a sponsor of the Breakaway Thinking series of blog posts. The Breakaway Group is a leader in EHR and Health IT training.