The key to health IT use in clinical research is interoperability and data sharing, according to the Healthcare Information Management Systems Society (HIMSS).
In a recent letter addressed to the acting commissioner of food and drugs at the Food and Drugs Administration (FDA) Stephen Ostroff, MD, HIMSS submitted its comments regarding the use of health IT during clinical investigations and investigational drugs. The letter addressed two major themes, including the limited federal intervention of health IT use and health IT interoperability.
In the letter’s introduction, HIMSS board chair Dana Alexander, RN, MSN, MBA, FAAN, FHIMSS, and HIMSS president and CEO H. Stephen Lieber, CAE, stated that the organization supports the use of health IT in carrying out clinical investigations. The pair also stated that it believes no government agency should create strict guidelines for the use of health IT in any setting:
HIMSS strongly discourages any federal agency from dictating specific technology tools that providers should be using in a particular care delivery model or to conduct research. Each provider will approach its IT structure differently, and should have the flexibility to implement the solutions that they require. Most technologies will have cross-functional purposes that support clinical research as well as innovative care delivery so there should be flexibility in adapting different technologies for different purposes.
To that end, HIMSS underscored the importance of health IT interoperability and information sharing. Because providers should have the freedom to choose the technology that would best suit its individual circumstances, interoperability is critical in ensuring information is transferred amongst the appropriate parties.
“There exist a range of relevant IT tools that providers can use to perform their duties. The applicability of the tools for care delivery are often one-in-the-same with the tools for the administration of clinical research,” Alexander and Lieber explained. “The agency should also expand its collaborations with other agencies on the use of IT tools to ensure that the interconnectedness of technology for research and care delivery can be maintained and promoted.”
Alexander and Lieber touched upon a few other suggestions for the FDA with regard to health IT. For example, the pair suggested that the FDA utilize industry knowledge when promoting technologies for clinical research. Additionally, they advocated for continued education in health IT, and stated that the FDA needs to foster an environment in which this continued education can occur.
Notably, Alexander and Lieber stated that the FDA must not stifle health IT innovation.
“In order to sustain rather than stifle innovation in the drive to use technologies and innovative methods in clinical research, there must be an acceptable level of clarity and predictability in terms of regulation and/or oversight,” the two wrote. “We recognize that the nature of health IT and its role in clinical research is constantly evolving, and that future regulatory action and oversight might be appropriate.”
Because there is the likelihood that health IT regulation may need to be amended as technologies evolve, Lieber and Alexander suggest the Department of Health and Human Services (HHS) and the FDA continually engage the public in feedback. By consulting with industry stakeholders, the FDA can ensure that health IT policies can be developed with clarity and consistency.
To conclude, Alexander and Lieber highlighted the importance of openness of data. This does not only include interoperable technologies, but patient engagement as well. As patients are continuing to contribute more of their own personal data, the pair acknowledged that openness of data and patient engagement can help improve clinical research outcomes.
“In terms of patient engagement and activation, it is also important to ensure that there is patient access to and portability of information from clinical trials,” Alexander and Lieber wrote. “As more people share their personal health information with or participate in clinical research, there should be some assurances put in place for patients to be able to access and use any information derived from those trials in the development of their own care plans.”
