healthcare

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.

The Office of the National Coordinator for Health IT shared "early strategic elements" of a draft 10-year roadmap for achieving an interoperable health IT infrastructure, Health Data Management reports (Slabodkin, Health Data Management, 10/16).

In June, ONC released a paper outlining health IT interoperability goals the agency hopes to achieve over a three-, six- and 10-year time period (iHealthBeat, 6/5).

The agency plans to release a final version of its 10-year national interoperability plan by the spring (Conn, Modern Healthcare, 10/15).

The updated draft roadmap was presented at a joint meeting of the Health IT Policy and Standards committees by ONC's Interoperability and Exchange Portfolio Manager Erica Galvez.

During the meeting, Galvez said ONC has adopted the Institute for Electrical and Electronic Engineers definition of interoperability, which calls for a system or product to work with other systems or products without special effort on the consumer's end.

She said that the draft report, which will be available for public comment in January 2015, takes an incremental approach to achieving interoperability (Health Data Management, 10/16). The draft report states:

• By 2017, providers and patients should be able to send, receive, find and use basic electronic health information;
• By 2020, providers and patients should be able to contribute to and access their health information at a granular level and seamlessly use remote monitoring devices;
• By 2024, patients should be able to regularly track and share data from mobile and medical devices electronically, and providers should have increased longitudinal information to contribute to a learning health system (ONC draft report, 10/15).

According to the draft report, ONC will create and launch a program that monitors who complies with the voluntary national framework (Bowman, FierceHealthIT, 10/14).

During her presentation, Galvez also touted the nation's existing interoperable system, noting, "There is a base from which we can build. We're not starting from zero."

For example, she noted that health care organizations have increased the number of directed exchange transactions through health information exchanges by 225% to more than 226.6 million transactions between the second quarter of 2012 and the fourth quarter of 2014 (Modern Healthcare, 10/16).

Overall, committee members generally agreed with the draft roadmap (Gold, PoliticoPro, 10/15).

In addition, the Health IT Now Coalition in a statement applauded ONC for a plan that "immediately challenges the status quo to think beyond pecuniary interests to transforming health care."  Health IT Now Coalition Executive Director Joel White said the Policy and Standards committees must "step up," take charge and demand better outcomes for consumers (Health Data Management, 10/16).

Committees Approve Several JASON Task Force Recommendations

Also on Wednesday, the Policy and Standards committees formally approved a set of six recommendations from the JASON task force that calls on CMS to focus efforts on public application programming interfaces, Clinical Innovation & Technology reports (Pedulli, Clinical Innovation & Technology, 10/16).

The JASON task force was created as a short-term joint workgroup under the Policy and Standards committees to analyze and synthesize feedback on a previously released JASON report, which was prepared by an independent group of scientists that advises the federal government on issues pertaining to science and technology (iHealthBeat, 9/4).

In a final report, the JASON task force recommended using Stage 3 of the meaningful use program as a "pivot point" to begin the transition to public APIs (Durben Hirsch, FierceEMR, 10/14).

Under the 2009 federal economic stimulus package, health care providers who demonstrate meaningful use of EHR systems can qualify for Medicaid and Medicare incentive payments.

Specifically, the committees approved recommendations to:

1. Focus on interoperability by realigning the meaningful use program and initiate adoption of public APIs;
2. Create a coordinated industry-based exchange architecture to support API-based interoperability;
3. Create nationwide data sharing networks;
4. Enable the public API to allow data- and document-level access to clinical and financial systems;
5. Develop priority API Services; and
6. Have ONC monitor the progress of adopting APIs and implement non-regulatory steps to assist with the adoption (Sullivan, Government Health IT, 10/15).

According to Healthcare Informatics, the committee members did not approve language that would encourage CMS and ONC to delay or stagger Stage 3 of the meaningful use program (Raths, Healthcare Informatics, 10/15).

The Policy and Standards committees will draft a letter to ONC and CMS formally endorsing the task force's recommendations (Clinical Innovation & Technology, 10/16).