Government

Please don’t air our dirty laundry!

Before running the summative usability evaluation for §170.314(g)(3) Safety-enhanced design we recommend that EHR vendors begin working with a usability expert to identify possible usability issues before they are exposed as “dirty laundry” in a formal report.

Crash test dummies and The Usability of Electronic Health Records

EHR vendors were quick to say that the 2015 Edition ONC Certification for Safety-enhanced Design are too burdensome, that they are too difficult to complete, and they are not necessary. (see for example http://www.healthcareitnews.com/news/ehr-vendors-uneasy-about-meaningful... ) Many EHR vendors would say let market forces take over and the Health IT industry will heal itself.

Patient Engagement, Usability, and Meaningful Use Stage 3

Patient Engagement

Patient engagement was a very hot topic at the recent HIMSS conference in Chicago. There was no shortage of exhibitors promoting their patient engagement tools and there were also several presentations that contained suggestions for better engaging patients. Some exhibitors that we spoke to were not aware of the proposed patient engagement rules (described below) and were very excited at the prospect of greater use of their tools.

The Promise of Health IT Is Suffering Under the Reality of Washington

by David LeDuc, iHealthBeat, Thursday, October 30, 2014

Health care systems around the world are being challenged by aging populations, chronic illness and revolutionary -- but expensive -- treatments. Addressing these issues is increasingly dependent on information, as health care is a data-rich, knowledge-driven industry. And yet, the regulations governing health data were developed at a time when the telephone and typewriter were among the most advanced technologies being used in most doctor's offices.

First, let's consider what's at stake. Applying health care data analytics, delivered in a digestible manner when and where it is needed, can lead to faster treatments coming to market, enhanced patient engagement and increased adherence to care plans, as well as reduced fraud -- all of which not only promise to improve the health of our nation's population, but also lower costs for patients and providers by eliminating needless procedures.  

Yet, with medical information doubling every five years, doctors are constrained by the volume of information -- more than 80% of which is unstructured -- which they must work to analyze in order to provide individualized, safe and effective treatment options. Unconnected health datasets provide incomplete pictures of the health statuses and health care practices of U.S. residents, often denying optimal solutions being available to patients in need. 

A more effective approach to health care is to use cutting-edge analytics software to turn data into clinical and business insights that are easily put to use by providers. Effective data analytics can make those insights available in real time for point of care decisions and productivity. Hospitals, medical centers and clinicians can be empowered by seamless, patient-centered, holistic and proactive approaches to drive their interactions with a patient and to deliver better care experiences that emphasize prevention and wellness.

The possible applications of data-driven analytics solutions are virtually endless. These tools can analyze diverse data sources to predict and medically investigate patient safety signals, thereby improving patient safety by identifying potential issues before they become a reality. They can analyze huge volumes of structured and unstructured clinical and operational data for medical institutions to uncover hidden insights. They can even help physicians deliver more accurate diagnosis and treatment decisions for illnesses, increasing practical expertise for a myriad of health care professionals that lack access to advanced knowledge resources. 

But while these IT solutions hold great promise for personalizing treatment and revolutionizing health care, current public policy is standing in the way. There is significant confusion in the market about what technologies may be regulated, by which agencies and to what standards.

Simply stated, America's outdated regulatory approach is harming the development and application of a wide range of data analytic software supporting this revolution, threatening to delay -- or even prevent -- the implementation of 21st century health care solutions. Regulatory uncertainty is holding back the full deployment of countless promising technologies that can help clinicians access more evidence-based medicine, provide patient populations with more individualized care and generate better patient/caregiver/provider engagement.

To address this, HHS recently released a report providing a proposed strategy and draft recommendations to address the problems and shortcomings of this outdated regulatory framework. The FDASIA report makes suggestions to enhance a risk-based regulatory and oversight structure to foster innovation and better ensure the safety and efficacy of a tech-enabled healthcare system. The strategy also correctly espouses a technology-neutral approach, identifying the need to ensure risk and corresponding controls are focused on the actual health IT functionality, rather than on the technology or platform (e.g., mobile, cloud-based, installed) on which such functionality resides.

Most importantly, the strategy promotes the need for three distinct categories of health IT, which should be treated differently based on risk. Those that present a high risk to patient safety must be regulated. Those that present no risk should remain unregulated. And the remainder, those that may pose some risk, should be subject to risk-based oversight that uses consensus standards and private certification bodies to efficiently verify that they function safely and effectively.

With this report, we now have virtually unanimous agreement about the opportunities offered by health IT and data analytics, the steep regulatory barrier to deploying these solutions more broadly, and the need for a new public policy framework that breaks down these barriers. 

The next step is for Congress to act: Leaders in Washington, D.C., must modernize current health IT regulations, which are a product of the 1970s. This new framework needs to be sufficiently flexible to be relevant for current technologies, but also able to accommodate the rapid and hugely promising evolution of health IT.

The good news is that legislation has been introduced in both houses of Congress to accomplish this objective. The bad news is that, like so much in Congress, it remains stalled. On Oct. 7, the Software & Information Industry Association joined with dozens of technology providers, health organizations and trade associations urging Congress to pass legislation to provide much-needed statutory clarity.

Congress should act now to comprehensively reform the regulatory structure for health IT. The longer this is delayed, the longer Americans may be denied the most advanced technologies that can save lives, improve overall outcomes and cut costs.

Source: iHealthBeat, Thursday, October 30, 2014