While the nation’s eyes were fixated on the deadlock in Congress over the House of Representatives and Senate versions of health reform legislation, the U.S. Department of Health and Human Services quietly issued Jan. 13 a pair of coordinated regulations which will significantly impact the way health care is delivered in this country over the next decade.

The regulations — which exceed 200 pages — are outgrowths of the 2009 economic stimulus bill, known as the Health Information Technology for Economic and Clinical Health, or HITECH, Act. Not even the election of a new senator from Massachusetts can derail these changes.

The current debate in Congress focuses largely upon how health care might be financed through an assortment of private and public insurance plans, health insurance reforms and an individual mandate for coverage. While these are monumental issues for our nation, they will largely impact the accessibility and cost of health care.

Americans interested in how health care will be delivered in the future, and whether care will be delivered with higher quality, improved care coordination and in a secure and private manner, should pay close attention to the HITECH Act.

Under the legislation, approximately $40 billion will be paid out to medical professionals and hospitals that adopt and make “meaningful use” of “certified” electronic health record, or EHR, systems.

Physicians and other health professionals can receive up to $44,000 each in federal subsidy payments by adopting qualified systems, while hospitals can receive several million dollars in additional reimbursements. The government carrot will turn into a stick in 2015 when Medicare begins financially penalizing providers who have not adopted qualifying EHR systems.

The systems are designed to replace the antiquated paper-based files that most health care providers still utilize. Everyone is familiar with the joke about doctors’ indecipherable handwriting. Well, it is no joke; the Institute of Medicine estimates medication errors are responsible for an annual estimated 1.5 million injuries and $3.5 billion in excess costs. EHR systems may not totally eliminate these problems, but they will make a big dent in them.

The regulations issued this month clarify what an EHR system must do to qualify for a federal subsidy. The keys are found in how HHS has chosen to define the terms “meaningful use” and “certified.”

The first set of regulations proposes to phase-in criteria for determining “meaningful use” in three stages.

Stage 1, which begins in 2011, includes 25 compliance measures for medical professionals, and 23 for hospitals. It will not be enough that the system serve as a passive electronic data depository. The system also must be interactive with providers, patients, public health agencies and, not surprisingly, DHHS.

For example, the system must offer drug-to-drug checks for incompatibility; transmit physician orders and prescriptions electronically; generate lists of patients by specific condition for quality improvement and outreach; send out reminders to patients; provide clinical decision support to providers; be capable of securely exchanging data with other treating providers; offer patients quick electronic access to their own records; provide immunization and syndromic surveillance data to public health agencies; and report on quality measures to Medicare. EHR systems that do not offer all of these bells and whistles will not be eligible for the federal subsidy.

Not only must EHR systems be capable of “meaningful use,” they must also be “certified.” The second set of HHS regulations establishes minimum technical specifications for data transport and exchange, content, vocabulary, privacy and security needed to achieve certification. Most importantly, to become “certified,” a system must be “interoperable” with other systems. In simple terms, the systems have to be able to talk to each other. A recently created federal agency, the Office of the National Coordinator for Health Information Technology, is charged with overseeing this certification process.

The “meaningful use” regulations are only proposed at this point, and are subject to further comment and change. The “certification” regulations become effective in 30 days. Combined, these regulations are expected to generate a flurry of activity as the health industry scrambles to achieve eligibility for the federal subsidies, which begin in 2011.

The level of subsidies will be reduced over time; conversely, late adopters of qualifying EHR systems will have a shorter period to achieve “meaningful use” compliance before incurring financial penalties under Medicare. Time will be of the essence as our nation’s health infrastructure is revolutionized under the HITECH Act.

James W. Thomas is the manager of Jackson Kelly PLLC’s Charleston business law department. His practice focuses primarily upon health care matters of a business, regulatory and operational nature.