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Health IT Regulatory Framework

[preamble]I have been saying this since the inception of the government wanting to control medicine. For any of their proposals to work, there can be only 1 EMR and 1 vendor for it equipment. These new regulations will significantly increase the costs of ehr adoption and maintenance. As government regulations increase manufacturers will increase their prices because its “certified” and pass it along to us and the doctors.

New meaningless certifications designed simply to increase costs. This is only the beginning.[backtopost]

Health IT Regulatory Framework

Health information technology, or health IT, is defined by the federal government’s Office of the National Coordinator for Health IT (ONC) as, “hardware, software, integrated technologies or related licenses, intellectual property, upgrades, or packaged solutions sold as services that are designed for or support the use by health care entities or patients for the electronic creation, maintenance, access, or exchange of health information.”

Health IT is the framework that enables the management of health information across multiple electronic systems and devices, such as wireless medical devices, hospital information systems, communications infrastructure, and electronic health record (EHR) systems.  Three federal agencies, the FDA, ONC and the Federal Communications Commission (FCC) each have unique responsibilities in the health IT arena.

As health IT evolves, we believe that all stakeholders should understand regulatory requirements surrounding its use.  Under the direction of the Food and Drug Administration Safety Innovation Act (FDASIA) of 2012, the FDA is working with FCC and ONC to propose a strategy and make recommendations on an appropriate, risk-based regulatory framework for health IT that promotes innovation, protects patient safety, and avoids unnecessary and duplicative regulation.

The three agencies are committed to a vision that supports a strong health system based on safe and innovative health IT that improves and advances public health.

The FDA, FCC and ONC plan to compile the strategy and recommendations into a report that is slated for release in 2014.