Health Information Technology Policy Statement

Background

Smart, digitally-enabled medical technologies are dramatically improving patient safety and the productivity of our health care system. However, despite successful studies and outcomes identified with the use of health information technologies (HIT), many barriers to adoption remain. To improve patient safety and the quality of care, AdvaMed supports developing incentives that will foster the timely adoption of these technologies

AdvaMed Position and Recommendations

• Many providers lack the financial ability or consistency of commitment required to make the up-front investment needed to install and operate an advanced HIT system. The federal government and other payers should provide financial incentives sufficient to spur widespread, rapid adoption of HIT throughout the health care system, including universal adoption of electronic health records. “Pay for performance” proposals should include incentives for adoption and use of health information technology.
• Unless an exception is met, provisions of the Federal healthcare program anti-kickback statute prohibit the offer or acceptance of anything of value in return for patient or item/service referrals. Likewise, unless an exception is met, the physician self-referral law (“Stark” law) prohibits hospitals from billing for items or services provided by physicians who have financial relationships with the hospital. These barriers to the dissemination of resources (financial, equipment or otherwise) should be modified to allow the use and adoption of HIT.

• Reimbursement systems should reward new modes of providing services that result in quality improvement or cost reduction for patient care, such as remote patient monitoring, computer-assisted surgery, imaging, telemedicine, and virtual physician visits.

• FDA regulation of software that is an integral to, or a functional part of a medical device should be risk-based and the minimum amount necessary to protect public health.
• The electronic health record (EHR) is not a medical device as it merely stores data for retrieval by a healthcare professional. EHR algorithms do not make diagnostic or treatment decisions, therefore the EHR should not be regulated by FDA.
• A private, independent, certification body is the most appropriate means of creating a credible, sustainable mechanism for ensuring the distribution of functional, secure, reliable, and interoperable EHR products into a national health information network.

The e-health system should be designed to assure that data from the electronic medical record will be available for studies to improve patient safety and quality of care and will include appropriate privacy protections, such as those in HIPAA.

-April 18, 2005