The Healthcare Information and Management Systems Society tells FDA that many hospitals, health systems, and app developers have no experience working with agency on regulatory issues.
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The Healthcare Information and Management Systems Society (HIMSS) is recommending that the U.S. Food and Drug Administration (FDA) educate the medical community on its regulation policies and deal with clinical decision support (CDS) applications and functionality in a separate draft. HIMSS also suggests that when the agency develops its definition of software assurance for mobile medical applications, it considers concepts that help clinicians improve the decision-making process as they deliver patient care.
The letter, signed by HIMSS president and CEO Stephen Lieber and Charlene Underwood, chair of the HIMSS board of directors, noted that many hospitals, health systems, and mobile medical application developers have no experience working with FDA on such regulatory issues.
"Due to this reality, HIMSS encourages the FDA to use every opportunity to educate hospitals, health systems, providers, and current and future developers on correct FDA policies and procedures for achieving success," the letter states.
Edna Boone, HIMSS' senior director for Mobile Initiatives, told InformationWeek Healthcare that the rapid adoption of mobile devices, particularly smartphones and tablets, and health apps by consumers and health care providers is unprecedented. This growth and the magnitude of options it brings are overwhelming existing operations, infrastructure, security, policy, and integration capabilities of healthcare systems, Boone observed.
"The FDA's response to this new technology, potentially regulating mobile medical applications, needs additional clarification for healthcare systems and small development shops who may not be familiar with medical device regulation," said Boone. "It is also essential for the FDA to reduce the confusion on their purposed regulation by further defining 'intended use' with clear definitions of consumer use versus healthcare professional use."
Through its draft guidance document, the FDA notified manufacturers, distributors, and other entities on the way it intends to apply its regulatory authority to medical software applications that clinicians use on mobile platforms.
In order to encourage comment from the medical community, the FDA asked a series of questions, one of which was: "What factors should FDA consider in determining the risk classification of different types of software that provide [Clinical Decision Support] functionality?"
To address this question, HIMSS responded by noting the benefits that electronic health records (EHRs) offer, including the ability to deliver quality care at the point-of-delivery by using a variety of software system support tools collectively known as Clinical Decision Support (CDS).
Because using CDS in broad terms "can be a challenge", HIMSS recommends "any FDA review of general CDS applications and functionality, especially CDS operating as an extension of an existing EHR, be addressed in separate draft guidance."
Another area of focus for HIMSS is guidance around stand-alone software that provides CDS. The FDA document did not address stand-alone software, preferring to provide guidance in a separate document to be released at a later date.
However, to support the safety of such software, and to further align current guidance on mobile medical applications with the planned guidance on stand-alone software, the FDA is seeking comment on the question:
"Are there specific controls that manufacturers should implement that could change the risk classification or reduce the premarket data requirements for particular types of stand-alone software that provide CDS functionality?"
To address this question, HIMMS suggested in its letter that, "when the FDA develops its definition of software assurance, it consider such concepts as software life cycle processes and product conformance to requirements, standards, and procedures. Software Assurance should include the disciplines of software quality, safety, reliability, usability, verification and validation, and in many cases independent verification and validation."
According to Jim St.Clair, HIMSS senior director for interoperability and standards, software assurance concepts are applied today in other industrial environments where the software is considered "mission critical", such as NASA. St.Clair explained that this level of scrutiny is especially important as mobile devices continue to grow in processing power and bandwidth to support applications that support decision-making, or contribute to diagnosis and treatment.
"Expanding the definition of software assurance to include concepts such as quality, safety, reliability, usability, verification, and validation can help physicians and other clinicians in their daily task of administering care to patients while using mobile devices and the health apps that run on them." St.Clair told InformationWeek Healthcare.
St.Clair noted that these definitions of software assurance will provide clinicians with the understanding and comfort that their mobile device applications are receiving a similar level of technical scrutiny in their design and development that are applied in other FDA-regulated environments.
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