Ensuring optimal health care is a delicate matter that requires government oversight, regulation and evaluation, which in turn may call for tools such as compliance software. In order to promote effective management of medical operations, state organizations are continually devising and enforcing rules that provide guidelines on the practices and technologies used in life sciences applications.
A group of federal agencies, including the Food and Drug Administration, the Federal Communications Commission and the Office of the National Coordinator for Health Information Technology, recently released a document outlining prospective health information technology policies as a part of the Food and Drug Administration Safety and Innovation Act.
The report presents a scheme that concentrates on health IT operations rather than the specific means through which they achieve their functionality. Moreover, the government organizations seek to create a structure that allows for future developments in the field, while remaining pertinent to present processes.
The agencies stated in the document that extra regulations will not be added to current requirements. Instead, the organizations think that an alternative method that cultivates the values of quality and safety is more important.
The approach proposed by the government bodies also emphasizes the careful utilization of voluntary means to promote transparency, capitalizing on the influence of best practices and standards and the implementation of validation and examination led by industry.
Unclear health IT technology classification
The FDA, FCC and ONC document contains ambiguities on the application of of categories to various forms of health IT technology, Mondaq reported. The organizations’ suggested classifications contain definitions that can be used to label certain types of functionalities, though clarity is lacking for products with operations that do not fit under the headings elaborated in the paper. However, configurable software solutions can help companies navigate this obscurity.
Clinical decision-making support programs are among the technologies whose regulation remains obscure in the current draft of the document. The Mondaq article noted that the report does not classify CDS applications as medical devices, despite their conformity with the criteria set forth in the Food Drug and Cosmetic Act. However, a subcategory of CDS technologies will be considered to be medical devices and will be regulated accordingly, though the specifics of these designation remain unclear.
“FDA will work with federal and private stakeholders to clarify the types of medical device clinical decision support that should be the focus of FDA oversight,” the document stated, according to the news source.
The FDA report did, however, indicate several types of CDS programs that fit the high-risk category of medical devices will be overseen by the agency, such as robotic surgical control and planning applications, electrocardiography analytical software and computer-assisted diagnostic and recognition tools.
Health IT operational categories
Though they remain somewhat unclear, the delineations drawn by the group of government agencies do outline multiple categories. The news outlet indicated that three broad headings serve as the primary bases for health IT operational classification: Medical Device Health IT Functionality, Health Management Health IT Functionality and Administrative Health IT Functionality.
For products that fall under the Administrative category, which is considered the least hazardous of the three, the FDA, ONC and FCC propose no supplementary supervision. Several types of items that fit under this heading, such as claims processing, billing, determination of eligibility for health benefits and scheduling.
The Medical Device division will be the primary target of the federal agencies’ regulatory attention, due in part to the greater dangers that may arise with products that belong to it. No further regulation will be imposed upon applications in this category either, but in this case the lack of additional measures is due to the current existence of standards for such functionalities. In light of these ongoing rules, producers of these technologies may consider quality management software to ensure effectiveness.
Efforts organized by the ONC will serve as the primary method for maintaining the safety of patients with regard to programs that fit in the Health Management classification. Reliance on ONC activities will stand in for the lack of an established system of standards.
On the whole, the draft report indicates that the FDA is easing up on the regulation of certain products, according to The Washington Post. Wes Rishel, an analyst with Gartner, highlighted the organization’s less strict attitude toward consumer devices.
“All told, it represents a relaxation of concerns for unexpected regulation,” he said. “It represents a relaxation of concerns for the Nike wristbands, and the home market blood oxygen testers and things like that, that are sold at Best Buy.”
However, the joint FDA, FCC and ONC document does indicate that health management applications, such as sharepoint migration, will still be supervised by federal authorities, the news outlet reported.
“Traditionally, [an electro-cardiogram is] a box, it comes on a table,” said Jeff Shuren, director for the Center for Devices and Radiological Health at the FDA, in an interview. “Today, there’s a software program we’ve cleared and it will transform your smartphone into an EKG machine. It’s used for the same purpose, and we treat it the same. It’s the same kind of function we’ve been regulating . . . [if it’s] the kind of stuff we’ve approached and approved to classify we still regulate it. It doesn’t matter if it’s in a big box or a small box.”