decisionhealth Newsletters, Part B News - 2014 Issue 4 (April)
IT report focuses regulatory efforts on medical devices, away from EHR
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Article Overview
This article explains a federal health IT report developed by FDA, ONC, and FCC under FDASIA and describes how it proposes to organize health information technology into categories with different levels of regulatory attention. It is relevant to physician practices, health IT vendors, compliance teams, and policy watchers who want to understand the broad direction of federal oversight, especially the distinction between routine practice systems and medical device-focused technology. The piece also notes the report’s next steps, including public input and eventual proposed regulations.
Why This Topic Matters
The article helps readers understand where federal regulators are likely to focus future oversight in health IT and where they are not. That distinction can affect product development, compliance planning, and adoption decisions for software used in clinical and administrative settings.
What You Will Learn
- How a federal health IT report frames risk-based oversight for different kinds of health technology
- Which broad categories of health IT are discussed in the report
- Why the report is relevant to physician practices and health technology stakeholders
- What next procedural steps are described for the report and future rulemaking
Who Should Read This
- Physician practices
- Health IT vendors
- Compliance professionals
- Healthcare administrators
- Policy analysts
- Medical practice managers
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