As health IT continues to have a growing impact across the industry, new draft guidances, regulations, and innovations have been introduced to better enhance interoperability and the healthcare experience for both providers and patients. The turn of a new year brought multiple updates in health IT that are likely to bring lasting implications.
Earlier this week, the Senate passed the Veterans in E-Health and Telemedicine Support Act of 2017
. The bipartisan legislation would expand the Department of Veterans Affairs’ (VA) telehealth programs and allow VA providers to cross state lines to practice telemedicine. A clause in the legislation would bar states from revoking the license, certification, or registration of healthcare providers who practice telemedicine across state lines. According to HealthcareITNews
, the legislation is crucial to the VA’s Anywhere to Anywhere telehealth program introduced in August. In November, the House of Representatives unanimously passed their version of the bill.
Clinical Decision Support Software
Before the end of the year, FDA commissioner Scott Gottlieb, MD, announced new digital health policies aimed at encouraging innovation and bringing efficiency and modernization to regulation. The first draft guidance, “Clinical and Patient Decision Support Software
,” outlined the agency’s approach to clinical decision support software (CDS), which is designed to help providers identify the most appropriate treatment plan for a patient’s disease or condition. The draft guidance clarified what types of CDS would no longer be considered a medical device, and thus would not be regulated by the FDA.
“This type of technology has the potential to enable providers and patients to fully leverage digital tools to improve decision making,” said Gottlieb in a statement
. “We want to encourage developers to create, adapt and expand the functionalities of their software to aid providers in diagnosing and treating old and new medical maladies.”
Advancing Policies in Medical-Device Approval Processes
As 2018 begins, the FDA is working on new processes to advance regulatory policy initiatives to further modernize the medical devices program and continue to foster new medtech innovation, according to Gottlieb in a blog post
on the FDA website. In the post, Gottlieb said to expect a draft guidance in the first quarter of the year that will outline new steps to modernize the 510(k) review, the pathway designed to assess the safety and effectiveness of medical devices, through a voluntary, alternative pathway for demonstrating substantial equivalence. In addition, the FDA will release a draft guidance making clear the factors that the agency may consider when assessing acceptable uncertainty about health risks as well as outline how it makes judgments about when it’s appropriate to place greater reliance on post-market data in order to facilitate access to certain innovation.
Later in the week, Gottlieb announced
that the FDA is taking another step to modernize its regulatory framework and make its review process more efficient. The agency issued a new, draft guidance
that describes how they intend to implement provisions enacted by Congress in order to purse the “least burdensome” means of assuring the safety and effectiveness of new devices so that innovations that benefit patients can reach them more efficiently.
ONC Releases Draft of Trusted Exchange Framework
The Office of the National Coordinator (ONC) on Health IT released its draft
of the Trusted Exchange Framework as it works towards achieving interoperability. The draft
has 2 parts:
- Principles for Trusted Exchange, which includes 6 principles stakeholders should adhere to in order to facilitate interoperability and the exchange of EHR information. The 6 principles are: standardization; transparency; cooperation and non-discrimination; privacy, security, and patient safety; access; and data-driven accountability.
- Minimum Required Terms and Conditions for Trusted Exchange, which provides specific terms and conditions that will be incorporated into a single Common Agreement.
To facilitate the framework, ONC will work with a single Recognized Coordinating Entity (RCE) selected through a competitive process. According to a HHS press release
, the Trusted Exchange Framework proposes policies, procedures, and technical standards necessary to advance single on-ramp to interoperability requested by Congress.
Tool to Help Providers Make Better Prescribing Decisions
In its effort to prevent the spread of resistant bacteria, the FDA announced
a website tool aimed at healthcare providers to help them make better prescribing decisions. The website will provide direct and timely access to information about when bacterial or fungal infections are likely to respond to a specific drug. Physicians will be able to use an antimicrobial susceptibility test (AST) results to aide them in choosing an appropriate antibacterial or antifugal drug for their patient.
Previously, each drug manufacturer updated its drug labeling with new breakpoint information, which had to be reviewed and approved by the FDA on a case-by-case basis. The new approach
allows the FDA to simultaneously update the breakpoints for multiple drugs that have the same active ingredient and share the information transparently through a dedicated FDA web page.