The degree to which the government should regulate industry is often a matter of debate. On the one hand, excessive regulation can discourage innovators from entering the market and suppress competition. On the other hand, anemic regulation can endanger public welfare. Countries that have implemented electronic health record (EHR) systems have struggled with how and to what extent to regulate them. The European Union is only now developing a legal framework for EU-wide EHR system testing and certification. The United States has already taken several steps to establish quality control for EHR systems.

In 2009, the US Congress enacted the Health Information Technology for Economic and Clinical Health (HITECH) Act. This law established an incentive program by which qualified providers could receive incentive payments if they became meaningful users of certified EHR systems. In order to implement the HITECH Act, the Centers for Medicare and Medicaid Services (CMS) issued a series of regulations that establish the standards for meaningful use and EHR system certification. This chapter describes these regulations and critiques them. It argues that while they constitute a good first step toward regulating the quality of EHR systems, they do not adequately address concerns about the technology's safety and usability.

THE MEDICARE AND MEDICAID INCENTIVE PROGRAMS

The Medicare and Medicaid incentive programs began in 2011. Medicare payments will continue through 2016, and Medicaid payments will continue until 2021. Different rules apply to eligible professionals and eligible hospitals or critical access hospitals (CAHs).

Eligible Professionals

Eligible professionals must choose to participate in either the Medicare or Medicaid program. Under the Medicare program, eligible professionals who demonstrate meaningful use of certified EHR technology can receive up to $43,720 over five consecutive years if they began participating by 2012. The regulations specify how participants can demonstrate meaningful use, as discussed later. Starting in 2015, eligible professionals who have not successfully demonstrated meaningful use are penalized by Medicare. They are subject to payment reductions starting at 1 percent and increasing each year that they fail to demonstrate meaningful use, but payments cannot be reduced by more than 5 percent.