The DirectTrust secure messaging technology developed by industry stakeholders is inquiring electronic health records (EHRs) companies and other health information technology (HIT) vendors to up their game.
Utilization of the DirectTrust secure messaging technology protocols has been ramping up over the years, but increased significantly in the year of 2016 with 98 million message transactions, which is the bulk of the 165 million transactions since being started in the year of 2013.
In large part, electronic health records (EHRs) and other health information technology products have been certified under the EHR meaningful use program to send and get Direct messages, “but the issue with certification is it does not test usability and certain features,” claims David Kibbe, MD, president and CEO at DirectTrust.
In a new report, DirectTrust secure messaging technology gives a series of suggestions for better functionality of Direct messaging covering transitions of care, clinical messaging and administration of the program. Direct works, Kibbe asserts, “but EHR usability is largely variable.”
For example, some suggestions for improving transitions of care involve all Direct messages sent in real-time and never batched for timed sends, certain kinds of messages might be automatically triggered by specific events like discharges or referrals, automated sending of messages to providers of record with Direct accounts in the sending system, and inclusion of patient-specific attachments.
The recently enacted 21st Century Cures Act involves provisions to measure EHR interoperability and usability in real episodes of use and Kibbe hopes framers of the act will look at Direct’s suggestions. The agency also might work with medical specialty groups to establish an EHR vendor grading system.
“We need to give vendors a great idea of what improvements are required to take better care of patients,” he adds.
Representatives of the HIMSS Electronic Health Record Association weren’t instantly available for comment. The report is available here.
Showing posts with label Century Cures Act. Show all posts
Showing posts with label Century Cures Act. Show all posts
Wednesday, February 15, 2017
Saturday, December 31, 2016
FDA not planning to establish guidance on CDS in 2017
Software developers who were expecting that the Food and Drug Administration’s Center for Devices and Radiological Health might release draft guidance on clinical decision support (CDS) software have once again been disappointed.
In accordance to the FDA, its Center for Devices and Radiological Health (CDRH) is considering establishing a variety of guidance in fiscal year 2017, involving its so-called “A-List” documents, those that the organization intends to publish between the time period of Oct. 1, 2016 and Sept. 30, 2017. Although, draft CDS guidance isn’t among CDRH’s priorities going into next year.
Among those disappointed that Clinical Decision Support (CDS) is not on the agency’s near-term agenda is Bradley Merrill Thompson, general counsel for the Clinical Decision Support (CDS) Coalition, which reflects software developers, providers, healthcare payers and medical device manufacturers.
“For the last 2 years, CDRH has placed in the category A priority list draft guidance on clinical decision support software. It is not on the list this year, despite the fact that CDRH hasn’t released the draft guidance,” says Thompson.
Thompson asserts that industry has been waiting for FDA guidance on CDS since the year of 2011. When it comes to software development, 5 years is an eternity, he asserts.
Without clarification on how the FDA plans to regulate CDS, the software category will sustain to be a gray area, leaving developers struggling to get funding and to put together business plans that precisely depict the expected regulatory path for their products, Thompson explains.
Survey results issued earlier this year by the CDS Coalition indicated that one-third of developers reported having to abandon CDS product development efforts due to the uncertainty over FDA regulations. Of those who pressed ahead despite the uncertainty, nearly two-thirds encountered significant delays.
In a written statement, an FDA spokesperson claimed that the agency is “carefully evaluating” the 21st Century Cures Act that was approved by Congress and signed into law earlier this month by President Obama, and it is “exploring all possible options for executing the responsibilities, involving the provision for clinical decision software, that we have been charged with under the new law.”
Thompson considers the FDA removed CDS from CDRH’s FY17 list of guidance documents because the agency plans to re-evaluate the requirement for CDS guidance in connection with implementing the 21st Century Cures Act.
“That legislation, in section 3060, adds the criterion that to be FDA regulated, Clinical Decision Support (CDS) software must not be transparent. In this context, transparent means that the doctor user can’t see through the software to the underlying sufferer data and the clinical logic applied by the software, such that the physician isn’t required to rely on the software,” claims Thompson. “My hope is that in connection with the legislation, FDA proceeds with the guidance, which is more significant now than ever before.”
Particularly, the CDS Coalition would like to comprehend how the agency plans to enforce the transparency concept. “The statute is very useful, but it will be very significant for FDA to express the agency’s views on how the language is to be interpreted and applied,” adds Thompson.
“I’ll be very anxious to see the FDA’s plans for implementing the Cures legislation,” he summarizes. “I certainly expect that they plan to proceed with this much required guidance.”
In accordance to the FDA, its Center for Devices and Radiological Health (CDRH) is considering establishing a variety of guidance in fiscal year 2017, involving its so-called “A-List” documents, those that the organization intends to publish between the time period of Oct. 1, 2016 and Sept. 30, 2017. Although, draft CDS guidance isn’t among CDRH’s priorities going into next year.
Among those disappointed that Clinical Decision Support (CDS) is not on the agency’s near-term agenda is Bradley Merrill Thompson, general counsel for the Clinical Decision Support (CDS) Coalition, which reflects software developers, providers, healthcare payers and medical device manufacturers.
“For the last 2 years, CDRH has placed in the category A priority list draft guidance on clinical decision support software. It is not on the list this year, despite the fact that CDRH hasn’t released the draft guidance,” says Thompson.
Thompson asserts that industry has been waiting for FDA guidance on CDS since the year of 2011. When it comes to software development, 5 years is an eternity, he asserts.
Without clarification on how the FDA plans to regulate CDS, the software category will sustain to be a gray area, leaving developers struggling to get funding and to put together business plans that precisely depict the expected regulatory path for their products, Thompson explains.
Survey results issued earlier this year by the CDS Coalition indicated that one-third of developers reported having to abandon CDS product development efforts due to the uncertainty over FDA regulations. Of those who pressed ahead despite the uncertainty, nearly two-thirds encountered significant delays.
In a written statement, an FDA spokesperson claimed that the agency is “carefully evaluating” the 21st Century Cures Act that was approved by Congress and signed into law earlier this month by President Obama, and it is “exploring all possible options for executing the responsibilities, involving the provision for clinical decision software, that we have been charged with under the new law.”
Thompson considers the FDA removed CDS from CDRH’s FY17 list of guidance documents because the agency plans to re-evaluate the requirement for CDS guidance in connection with implementing the 21st Century Cures Act.
“That legislation, in section 3060, adds the criterion that to be FDA regulated, Clinical Decision Support (CDS) software must not be transparent. In this context, transparent means that the doctor user can’t see through the software to the underlying sufferer data and the clinical logic applied by the software, such that the physician isn’t required to rely on the software,” claims Thompson. “My hope is that in connection with the legislation, FDA proceeds with the guidance, which is more significant now than ever before.”
Particularly, the CDS Coalition would like to comprehend how the agency plans to enforce the transparency concept. “The statute is very useful, but it will be very significant for FDA to express the agency’s views on how the language is to be interpreted and applied,” adds Thompson.
“I’ll be very anxious to see the FDA’s plans for implementing the Cures legislation,” he summarizes. “I certainly expect that they plan to proceed with this much required guidance.”
Thursday, December 22, 2016
How information from Lyme disease study can affect the patient care
Information from a major Lyme disease study, which impacts 380,000 Americans yearly, indicate the benefits of early diagnosis but also the failure of physicians to rightly diagnose the disease.
Transmitted by the bite of ticks, specifically infected black-legged ticks, people might not even know they have been bitten, which can delay diagnosis. But preliminary analysis in a survey of almost 4,300 sufferers with results presented at the latest Columbia University/Lyme Disease Association Conference finds a third of sufferers diagnosed early reporting being well; by contrast, just 9% of those whose diagnosis was delayed reported that they felt well.
Even so, most sufferers diagnosed early, 68%, reported that their condition was worse, even with early identification of the sickness.
Information in the research comes from the MyLymeData patient registry that has enrolled more than 6,500 sufferers who input data about their condition and experiences with the illness.
“Patient-powered registries that pool huge amounts of information will be a game changer for misunderstood sicknesses like Lyme disease,” claimed Lorraine Johnson, CEO at Lyme Disease.org. “Big data holds the key to future diagnostics and treatments for sufferers.”
Johnson considers the recently enacted 21st Century Cures Act will give required support to patient-driven observational researches, using real-world evidence to make better care.
With data from thousands of sufferers now in the registry, the Lyme disease study is expanding to detect the course of ailment and responses to treatment. Existing registered sufferers and new patients coming into the program are motivated to complete new survey sections. Further information, involving a list of symptoms, is available here.
Transmitted by the bite of ticks, specifically infected black-legged ticks, people might not even know they have been bitten, which can delay diagnosis. But preliminary analysis in a survey of almost 4,300 sufferers with results presented at the latest Columbia University/Lyme Disease Association Conference finds a third of sufferers diagnosed early reporting being well; by contrast, just 9% of those whose diagnosis was delayed reported that they felt well.
Even so, most sufferers diagnosed early, 68%, reported that their condition was worse, even with early identification of the sickness.
Information in the research comes from the MyLymeData patient registry that has enrolled more than 6,500 sufferers who input data about their condition and experiences with the illness.
“Patient-powered registries that pool huge amounts of information will be a game changer for misunderstood sicknesses like Lyme disease,” claimed Lorraine Johnson, CEO at Lyme Disease.org. “Big data holds the key to future diagnostics and treatments for sufferers.”
Johnson considers the recently enacted 21st Century Cures Act will give required support to patient-driven observational researches, using real-world evidence to make better care.
With data from thousands of sufferers now in the registry, the Lyme disease study is expanding to detect the course of ailment and responses to treatment. Existing registered sufferers and new patients coming into the program are motivated to complete new survey sections. Further information, involving a list of symptoms, is available here.
Wednesday, November 30, 2016
House of Representatives set to vote today on 21st Century Cures bill
After 2 years of legislative wrangling, the House of Representatives is all ready to vote today on the 21st Century Cures Act bill involving various health IT provisions created to deal the issues of electronic health record usability, interoperability, and data blocking.
Speaking on the floor of the Senate yesterday in advance of today’s House vote, Sen. Lamar Alexander (R-Tenn.) applauded the legislation’s $6.3 billion in appropriations to support the Obama administration’s Cancer Moonshot ($1.8 billion), Brain Research through Advancing Innovative Neuro technologies ($1.6 billion), and Precision Medicine Initiative ($1.4 billion). The bill finds to speed the approval of latest medicines and medical devices, among other provisions.
Alexander, chairman of the Senate health committee, also termed out the 21st Century Cures bill’s attempts to make better the health IT. Noting that the federal government has spent more than $30 billion on incentives to get providers to accept electronic health records (EHRs), he charged that EHR systems are a “mess” and desperately require fixing.
“Various portions of the bill concentrate on 2 critical areas where improvement is required to better leverage health IT and EHRs to their full potential,” claims Ben Moscovitch, manager of HIT at The Pew Charitable Trusts. “Those 2 areas are enhanced interoperability and improved usability and patient safety.”
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