Thursday, May 01, 2014

I Think This Is A Real Biggie! An New Approach To Risk Management In Health IT From The US Regulators.

This appeared a little while ago.

HHS publishes FDASIA framework for health IT

April 3, 2014 | By Dan Bowman
The U.S. Department of Health & Human Services, on Thursday, published the long-awaited proposed strategy and draft recommendations for a health IT risk-based framework mandated by the Food and Drug Administration Safety and Innovation Act.
The 34-page draft report--a collaborative effort by officials from the FDA, the Federal Communications Commission and the Office of the National Coordinator for Health IT--outlines a strategy that identifies three categories of health IT: administrative health IT functions; health management health IT functions; and medical device health IT functions. Risk and corresponding controls, the report's authors said, should focus on the functionality of health information technology, as opposed to the platforms on which that functionality lives.
"The proposed strategy and recommendations reflect the Agencies' understanding that risks to patient safety and steps to promote innovation: 1) can occur at all stages of the health IT product lifecycle; and 2) must consider the complex sociotechnical ecosystem in which these products are developed, implemented and used," the authors said.
The authors stressed a more narrow approach health IT guidance equally reliant on private sector capabilities and activities coordinated by ONC, but without additional oversight by the FDA.
"We believe a better approach is to foster the development of a culture of safety and quality; leverage standards and best practices; employ industry-led testing and certification; and selectively use tools such as voluntary listing, reporting and training to enable the development of a healthcare environment that is transparent and promotes learning to foster continual health IT improvement," they said.
Four areas prioritized by the report's authors for the report include:
  • Promotion of the use of quality management principles
  • Identification, development and adoption of standards and best practices
  • Leveraging conformity assessment tools
  • Creation of an environment that focuses on learning and continual improvement
Lots more here with links:
There is a lot of coverage to be found:
First here:

Fed HIT Report Provides Few Details on Clinical Decision Support Software

APR 4, 2014
In a risk-based regulatory framework for health IT released April 3 by federal agencies, clinical decision support software got major billing. In fact, an entire section of the draft report, developed by the Food and Drug Administration in coordination with the Office of the National Coordinator for Health IT and Federal Communications Commission, was devoted to CDS software. However, the level of detail in the report is lacking.    
"Frankly, just about everything in the CDS section was already known, except for maybe two or three of the examples that they gave of unregulated CDS. Basically there just wasn't much new there," Bradley Merrill Thompson, an attorney at Washington, D.C.-based law firm Epstein Becker Green who counsels medical device companies on FDA regulatory issues, told Health Data Management. 
The proposed FDA/ONC/FCC strategy divides health IT products into three categories--administrative health IT, health management heath IT, and medical device health IT--based on function and risk. Under the proposed framework, most clinical decision support software would fall into the health management heath IT category based on functions that "are of sufficiently low risk and thus, if they meet the statutory definition of a medical device, FDA does not intend to focus its oversight on them." Instead, the draft report proposes relying primarily on ONC-coordinated activities and private sector capabilities that highlight quality management principles, industry standards and best practices. The draft report also proposes to rely on tools for testing, certification and accreditation of this category of products.
Lots more here:
Second here:

Feds Want Ideas on Assuring HIT Products are Safe

APR 3, 2014
Certification, accreditation, conformity assessment; call it what you will, but some type of program to assure health information technology products meet certain benchmarks for safety is coming. And the federal government, while being a player and helping to facilitate, clearly is throwing the ball to stakeholders to get it done.
The new proposed regulatory framework for HIT safety favors a voluntary program that can be performed by the private sector or government. Private sector assessments may have advantages such as increased efficiency, promotion of consumer transparency and economic competition, and reduced government costs, according to the report from the Food and Drug Administration, Office of the National Coordinator for HIT and Federal Communications Commission. But government assessments may be more appropriate in assuring the safety and health of consumers. Which way to go should be decided with broad input from stakeholders, report authors say.
“Importantly, the agencies do not propose that new or additional mandatory conformity assessments be required prior to the production, marketing or use of a specific health IT product or service. Instead, we recommend that these tools should be used and applied in a risk-based manner to distinguish high quality products and organizations from those that fail to meet basic performance standards or requirements. The agencies seek input on the value and role of voluntary conformity assessment tools for various health IT stakeholders during the different stages of the health IT product lifecycle, and whether various types of conformance testing can support innovation, such as by providing assurances during development phases to reduce risk.”
Lots more here:
Last here:

HHS proposes new HIT software regulation

By staff writers

April 3, 2014 -- The U.S. Department of Health and Human Services (HHS) on Thursday released a report that recommends a new regulatory framework for healthcare IT software.
The goal of the proposed framework is to improve the federal government's regulation of healthcare IT applications by promoting product innovation while maintaining patient protection and avoiding regulatory duplication. The report was developed by the U.S. Food and Drug Administration (FDA), in collaboration with the Office of the National Coordinator for Health IT (ONC) and the Federal Communications Commission (FCC).
The report proposes a regulatory framework that would divide healthcare IT software into three categories, based on functionality and risk.
  1. Low-risk software that performs administrative healthcare IT functions, such as applications for billing and claims processing, scheduling, and practice and inventory management.
  2. Medium-risk software with health management IT functions, such as software for health information and data management, medication management, provider order entry, knowledge management, electronic access to clinical results, and clinical decision support.
  3. Higher-risk software that could pose a greater risk to patients if it does not function as intended. Applications in this category include computer-aided detection (CAD) software, applications for bedside monitor alarms, and radiation treatment software.
More here:
This is a draft report that needs to read by all interested in the topic.

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