Oct 8, 2018 | Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology, Laboratory Testing
Both health systems will use their EHRs to track genetic testing data and plan to bring genetic data to primary care physicians
Clinical laboratories and pathology groups face a big challenge in how to get appropriate genetic and molecular data into electronic health record (EHR) systems in ways that are helpful for physicians. Precision medicine faces many barriers and this is one of the biggest. Aside from the sheer enormity of the data, there’s the question of making it useful and accessible for patient care. Thus, when two major healthcare systems resolve to accomplish this with their EHRs, laboratory managers and pathologists should take notice.
NorthShore University HealthSystem in Illinois and Geisinger Health System in Pennsylvania and New Jersey are working to make genetic testing part of primary care. And both reached similar conclusions regarding the best way for primary care physicians to make use of the information.
One area of common interest is pharmacogenomics.
At NorthShore, two genetic testing programs—MedClueRx and the Genetic and Wellness Assessment—provide doctors with more information about how their patients metabolize certain drugs and whether or not their medical and family histories suggest they need further, more specific genetic testing.
“We’re not trying to make all of our primary care physicians into genomic experts. That is a difficult strategy that really isn’t scalable. But we’re giving them enough tools to help them feel comfortable,” Peter Hulick, MD, Director of the Center for Personalized Medicine at NorthShore, told Healthcare IT News.
Conversely, Geisinger has made genomic testing an automated part of primary care. When patients visit their primary care physicians, they are asked to sign a release and undergo whole genome sequencing. An article in For the Record describes Geisinger’s program:
“The American College of Medical Genetics and Genomics classifies 59 genes as clinically actionable, with an additional 21 others recommended by Geisinger. If a pathogenic or likely pathogenic variant is found in one of those 80 genes, the patient and the primary care provider are notified.”
William Andrew Faucett (left) is Director of Policy and Education, Office of the Chief Scientific Officer at Geisinger Health; and Peter Hulick, MD (right), is Director of the Center for Personalized Medicine at NorthShore University HealthSystem. Both are leading programs at their respective healthcare networks to improve precision medicine and primary care by including genetic testing data and accessibility to it in their patients’ EHRs. (Photo copyrights: Geisinger/NorthShore University HealthSystem.)
The EHR as the Way to Access Genetic Test Results
Both NorthShore and Geisinger selected their EHRs for making important genetic information accessible to primary care physicians, as well as an avenue for tracking that information over time.
Hulick told Healthcare IT News that NorthShore decided to make small changes to their existing Epic EHR that would enable seemingly simple but actually complex actions to take place. For example, tracking the results of a genetic test within the EHR. According to Hulick, making the genetic test results trackable creates a “variant repository,” also known as a Clinical Data Repository.
“Once you have that, you can start to link it to other information that’s known about the patient: family history status, etc.,” he explained. “And you can start to build an infrastructure around it and use some of the tools for clinical decision support that are used in other areas: drug/drug interactions, reminders for flu vaccinations, and you can start to build on those decision support tools but apply them to genomics.”
Like NorthShore, Geisinger is also using its EHR to make genetic testing information available to primary care physician when a problem variant is identified. They use EHR products from both Epic and Cerner and are working with both companies to streamline and simplify the processes related to genetic testing. When a potentially problematic variant is found, it is listed in the EHR’s problem list, similar to other health issues.
Geisinger has developed a reporting system called GenomeCOMPASS, which notifies patients of their results and provides related information. It also enables patients to connect with a geneticist. GenomeCOMPASS has a physician-facing side where primary care doctors receive the results and have access to more information.
Andrew Faucett, Senior Investigator (Professor) and Director of Policy and Education, Office of the Chief Scientific Officer at Geisinger, compares the interpretation of genetic testing to any other kind of medical testing. “If a patient gets an MRI, the primary care physicians doesn’t interpret it—the radiologist does,” adding, “Doctors want to help patients follow the recommendations of the experts,” he told For the Record.
The Unknown Factor
Even though researchers regularly make new discoveries in genomics, physicians practicing today have had little, if any, training on how to incorporate genetics into their patients’ care. Combine that lack of knowledge and training with the current lack of EHR interoperability and the challenges in using genetic testing for precision medicine multiply to a staggering degree.
One thing that is certain: the scientific community will continue to gather knowledge that can be applied to improving the health of patients. Medical pathology laboratories will play a critical role in both testing and helping ensure results are useful and accessible, now and in the future.
—Dava Stewart
Related Information:
Introducing “Genomics and Precision Health”
How NorthShore Tweaked Its Epic EHR to Put Precision Medicine into Routine Clinical Workflows
Precise, Purposeful Health Care
Next-Generation Laboratory Information Management Systems Will Deliver Medical Laboratory Test Results and Patient Data to Point of Care, Improving Outcomes, Efficiency, and Revenue
Sep 17, 2018 | Compliance, Legal, and Malpractice, Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology, Managed Care Contracts & Payer Reimbursement, Management & Operations
Ongoing federal regulatory push for EHR interoperability requires medical laboratories and anatomic pathology groups to have strategies for ensuring seamless interfaces with providers and hospitals
What difference does a name make? Clinical laboratories and anatomic pathology groups soon may know the answer to that question following the renaming of the Centers for Medicare and Medicaid Services (CMS) “Meaningful Use” program to “Promoting Interoperability” (PI).
CMS first announced the rebranding in April as part of a proposed rule aimed at transforming the Meaningful Use aspect of the federal Health Information Technology for Economic and Clinical Health (HITECH) Act. HITECH has been Medicare’s roadmap to electronic health record (EHR) implementation and interoperability since it was enacted in 2009.
The final rule arrived on August 2, 2018, and it may impact how clinical laboratories interface with provider and hospital EHRs.
Removing Obstacles to Quality Patient Care
In the news release outlining the updates to Medicare payment policies and rates under the Inpatient Prospective Payment System and the Long-Term Care Hospital Prospective Payment System, CMS states the “overhaul” of the meaningful use program will:
- Make the program more flexible and less burdensome;
- Emphasize measures that require the exchange of health information between providers and patients; and,
- Incentivize providers to make it easier for patients to obtain their medical records electronically.
“We’re excited to make these changes to ensure care will focus on the patient, not on needless paperwork,” CMS Administrator Seema Verma stated in the news release. “We’ve listened to patients and their doctors who urged us to remove the obstacles getting in the way of quality care and positive health outcomes. Today’s final rule reflects public feedback on CMS proposals issued in April and the agency’s patient-driven priorities of improving the quality and safety of care, advancing health information exchange and usability, and removing outdated or redundant regulation on healthcare providers to make way for innovation and greater value.” (Photo copyright: Centers for Medicare and Medicaid Services.)
According to a CMS fact sheet, key provisions of the overhaul include:
- The rule finalized an EHR reporting period to a minimum of any continuous 90-day period in each of calendar years 2019 and 2020 for new and returning participants attesting to CMS or their State Medicaid agency;
- For the Medicare Promoting Interoperability Program, the rule finalized a new performance-based scoring methodology consisting of a smaller set of objectives that CMS states will provide a more flexible, less-burdensome structure, allowing eligible hospitals and critical access hospitals (CAHs) to place their focus back on patients;
- CMS finalized two new e-Prescribing measures related to e-prescribing of opioids (Schedule II controlled substances); and,
- Beginning with an EHR reporting period in CY 2019, all eligible hospitals and CAHs under the Medicare and Medicaid PI programs will be required to use the 2015 Edition of Certified EHR Technology;
- CMS finalized changes to measures, including removing certain measures CMS believes do not emphasize interoperability and the electronic exchange of health information.
According to CMS, about 3,300 acute care hospitals and 420 long-term care hospitals will be subject to the final rule, which takes effect October 1. Obviously, medical laboratories servicing these healthcare organizations will be similarly affected.
Rebranding More than a Name Change
Healthcare Informatics analyzed the 2,593-page final rule explaining that the “core emphasis” of the meaningful use overhaul is “on advancing health data exchange among providers.”
The initial proposal in April, according to Healthcare Informatics, invited stakeholder feedback through a request for information on the possibility of revising CMS’ “Conditions of Participation” for hospitals by requiring providers to electronically transfer medically necessary information following a patient discharge or transfer. The final rule, however, did not include that change.
Instead, the CMS Fact Sheet on the rule states the April request for information was “to obtain feedback on positive solutions to better achieve interoperability, or the sharing of healthcare data between providers, which will inform next steps in advancing this critical initiative.”
Rebranding meaningful use is CMS’s first step in implementing core pieces of the Administration’s MyHealthEData Initiative to strengthen interoperability. In remarks during the ONC Interoperability Forum in Washington, DC, CMS Administrator Seema Verma described the rebranding decision as “much more than a name change” and signaled future CMS actions.
“It is a change in direction for the programs—from programs that support the adoption of health IT, to programs that promote interoperability and patient access to data,” she explained. “To avoid payment reductions and gain incentives, doctors and hospitals will have to give patients electronic access to their health records. We are also considering whether CMS should require—as a condition of participation in the Medicare program—that providers share data with patients in a universal electronic format and hope to share more information on that soon.”
The recent changes follow passage of the Bipartisan Budget Act of 2018, which included a provision relaxing meaningful-use requirements. Though the legislation affects only hospitals and outpatient Medicaid providers, Robert Tennant, Director of Health Information Technology Policy for the Medical Group Management Association (MGMA), declared the revision a “huge win” for providers.
“I don’t think the government recognized how difficult it would be to move from stage 1 to stage 2 to stage 3 [meaningful use] requirements and the significant costs involved,” Tennant stated told Modern Healthcare. “We hope that it signals an interest in Congress in having the administration and HHS (Federal Health and Human Services) not make these quality reporting programs so onerous that it results in large swaths of providers not being successful.”
Clinical laboratories and anatomic pathology groups should be aware that interoperability between their laboratory information systems and the EHRs of providers and hospitals continues to be important. Although the term “Meaningful Use” is to be supplanted by “Promoting Interoperability,” the ability to move patient health information seamlessly among providers continues to be a major goal of this country’s healthcare system.
—Andrea Downing Peck
Related Information:
CMS Finalizes Changes to Empower Patients and Reduce Administrative Burden
In Proposed MU Rebranding Rule, CMS Raises the Interoperability Stakes
Fact Sheet: Fiscal Year (FY) 2019 Medicare Hospital Inpatient Prospective Payment System (IPPS) and Long-Term Acute Care Hospital (LTCH) Prospective Payment System Final Rule (CMS-1694-F)
H.R. 1892: Bipartisan Budget Act of 2018
Printable PDF: Final Rule (CMS-1694-F)
Speech: Remarks by Administrator Seema Verma at the ONC Interoperability Forum in Washington, DC
Congress Budget Deal Relaxes Meaningful-Use Requirements
CMS Proposes Changes to Empower Patients and Reduce Administrative Burden
CMS Proposes Meaningful Use Changes to Promote Interoperability
Sep 10, 2018 | Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology, Laboratory Testing, Management & Operations
Clinical laboratory test claims make up a substantial proportion of all claims filed each year. Thus, any effort to streamline or reform claims adjudication and administration in the US will alter how labs and pathologists conduct business
Clinical laboratory managers and anatomic pathologists know how costly and complex the US healthcare system can be. However, expenses associated with care and treatment are only part of the total picture. Resources devoted to paperwork and administrative costs apparently increase overall expenditures associated with healthcare to a much higher degree than is generally known.
That’s according to several studies The New York Times reported on in July.
US Administrative Costs Higher than All Other Nations
One study conducted by The New England Journal of Medicine (NEJM) in 2003 estimated administrative costs account for approximately 30% of all healthcare expenditures in the US. The researchers examined data from 1999 to reach those conclusions. In today’s economy, those numbers are higher. On average, $5,700 of every $19,000 that US workers and their employers pay for family coverage each year goes towards administrative costs.
A 2014 study published by Health Affairs compared administrative costs for US hospital expenditures to those of seven other countries: Canada, England, France, Germany, the Netherlands, Scotland, and Wales. This study evaluated data from 2010/2011 and found that hospital administrative costs in the US far exceed rates in other nations. According to the study, administrative costs accounted for:
- 25.3% of total hospital expenditures in the US;
- 19.8% in the Netherlands;
- 15.5% in England; and,
- 12% in Canada and Scotland.
According to the Health Affairs study, more than $150 billion could have been saved in 2011 by reducing per capita spending for administrative costs to the levels observed in Canada and Scotland.
“The extraordinary costs we see are not because of administrative slack or because healthcare leaders don’t try to economize,” Kevin Schulman, MD, Professor, Department of Medicine, Duke University, and co-author of the Health Affairs study told The New York Times. “The high administrative costs are functions of the system’s complexity.” (Photo copyright: Duke University.)
Complexity of Payer System Partly to Blame
One reason for the costliness in the US healthcare system is the myriad of payers that healthcare organizations have to grapple with to receive payment. Private health insurers and public health programs like Medicare and Medicaid, each have their own procedures, regulations, and forms that need to be submitted to receive payments. This translates to more employee time devoted to billing.
Another factor driving costs is the staff time devoted to the collection of debts. A 2017 Health Affairs study examined medical claims data from 88,000 healthcare providers contracted with Athenahealth to determine the percentage of bills paid within one year from the initial service.
The study found that 93.8% of patient bills under $35 were paid within a year. However, that percentage decreased as the patient obligation increased:
- 90.5% of patients paid bills between $35 and $75 within one year;
- 83.7% paid bills between $75 and $200 in the same time period; however,
- When bills increase to $200 or more, just 66.7% were paid within a year’s time.
Providers wrote off approximately 16% as abandoned or bad debts, with an additional 17% going to collection agencies.
Another study, published in Health Affairs in 2009, surveyed 895 physicians about the time they spent dealing with administrative tasks. On average, physicians reported spending 43 minutes per workday interacting with health plans. This number is the equivalent of three hours/week and almost three weeks/year. Those numbers have reportedly increased since then.
EHRs Do Not Reduce Administrative Costs, Contrary to Belief
Efforts have been made to reduce administrative costs in the US healthcare industry. One such measure involved increased use of certified electronic health record (EHR) systems, which the federal government spent billions of dollars promoting and incentivizing providers to adopt on the claim that EHRs would reduce healthcare costs, in part by removing most of the paperwork.
However, a 2018 study published in the Journal of the American Medical Association (JAMA) reported the adoption of EHRs did not reduce administration costs. Researchers at Duke University and Harvard Business School utilized a cutting-edge accounting method to determine the administrative costs within a large academic healthcare system that was using a certified EHR.
Their study determined the administrative costs for processing a single medical bill ranged from $20 for a doctor visit to $215 for an inpatient surgical procedure. These costs accounted for 3%-25% of total professional revenue for the provided services.
“We need to understand better how complexity is driving these enormous costs within the system, costs that do not add value to patients, employers, or providers,” noted Barak Richman, JD, PhD, Duke University School of Law and Margolis Center for Health Policy, one of the study’s authors.
Clinical Lab Test Claims a Major Portion of Administrative Costs
Nevertheless, administrative costs are a necessary part of doing business and not always as negative as perceived. An article published by Health Affairs in 1992 divided administrative costs in the healthcare industry into four categories:
- Transaction-related: claims processing, billing, admissions, and tracking employee hiring/terminations;
- Benefits Management: quality assurance, plan design, statistical and internal analyses, and management information systems;
- Selling and Marketing: strategic planning, underwriting, and advertising; and,
- Regulatory and Compliance: waste management, licensing requirements, and discharge planning.
“We hope that this work is the first step toward informing policy solutions that could reduce these non-value-added costs largely hidden within the healthcare system,” Schulman stated in a Duke University news release.
The issue of costly paperwork and administrative expenditures is significant for the clinical laboratory profession as lab test claims make up a substantial portion of all medical claims filed annually. Efforts to streamline or reform claims adjudication and administration will have an impact on the way clinical labs and anatomic pathology groups conduct business in the future.
—JP Schlingman
Related Information:
Hidden from View: The Astonishingly High Administrative Costs of U.S. Health Care
NEJM: Costs of Health Care Administration in the United States and Canada
Heath Affairs: A Comparison of Hospital Administrative Costs in Eight Nations: US Costs Exceed All Others by Far
Heath Affairs: Inside the Black Box of Administrative Costs
Heath Affairs: As Patients Take on More Costs, Will Providers Shoulder the Burden?
Heath Affairs: What Does It Cost Physician Practices to Interact with Health Insurance Plans?
Electronic Health Records Don’t Reduce Administrative Costs
Simplifying Administration of Health Insurance
Sep 5, 2018 | Instruments & Equipment, Laboratory Instruments & Laboratory Equipment, Laboratory Management and Operations, Laboratory Pathology, Laboratory Testing
While approaches differ between the three companies, heavy investment in EMR/EHR and other HIT solutions could signal significant changes ahead for a market currently dominated by only a few major developers
If healthcare big data is truly a disruptive force in healthcare’s transformation, then a big battle looms for control of that data. Some experts say that the companies now dominating the electronic health record (EHR) market will soon face tough competition from the world’s biggest tech companies.
Until recently, most clinical laboratories, anatomic pathology groups, hospitals, and other healthcare providers have depended on EHR systems from just a handful of health information technology (HIT) developers. But tech giants Google, Apple, and Microsoft have been filing hundreds of HIT related patents since 2013 and appear poised to compete on a large scale for a chunk of the EMR/EHR/HIT market, according to coverage in EHR Intelligence of Kalorama Information’s “EMR 2018: The Market for Electronic Medical Records” report.
How this will impact medical laboratories and pathology practices remains to be seen. Labs are sure to be influenced by coming events, since clinical laboratory test data represents the largest proportion of an individual patient’s permanent medical record. It’s important to note, though, that while most EHR/HIT developers have been motivated by federal incentives, Google (NASDAQ:GOOG), Apple (NASDAQ:AAPL), and Microsoft (NASDAQ:MSFT) are motivated by consumer demand, which increasingly dictates the direction of health technology development.
Thus, they may be better positioned to compete moving forward, as patients, physicians, and hospitals turn to precision medicine and value-based care for improved outcomes and increased revenues.
“The EMR efforts have moved hospitals from paper to digital records,” Bruce Carlson (above), Publisher of Kalorama Information, told HIT Infrastructure. “The next step is for tech giants to glean the data and improve upon that infrastructure. We’ll be talking about EHR in different ways in the next ten years.” (Photo copyright: Twitter.)
EMR/EHR Market Poised for Disruption
According EHR Intelligence, as of 2017, 97% of all US non-federal acute care hospitals and 84% of US hospitals had adopted an EHR system. Of these hospitals, more than half (50.5%) use products from just two developers—Cerner or Epic. That’s according to Health Data Management’s coverage of the KLAS report “US Hospital EMR Market Share 2017.”
However, recent interest in HIT and EHR systems by major Silicon Valley tech companies could lead to potential disruptions in the current state of the market. According to The New York Times, in the first 11 months of 2017, 10 of the largest US technology companies were involved in healthcare equity deals worth $2.7-billion. This marks a drastic increase over the 2012 figure of $277-million.
Though each company is approaching the market differently, Google, Microsoft, and Apple are all working on projects that could influence how both consumers and healthcare professionals interact with and utilize medical record data.
Of the three, Apple is the most consumer-centric with their Apple Health personal health record (PHR) integration into Apple iOS for iPhones and iPads. Microsoft, however, is working on developing analytics tools and storage solutions aimed at healthcare providers in general. And Google, through its parent company Alphabet, is focusing on data processing and storage.
Amazon also is working on its own HIT project which it calls 1492. While details are scant, HIT Infrastructure reports that the project is focused on interoperability among disparate EHR systems to improve sharing of protected health information (PHI) between providers, patients, and other healthcare providers, such as clinical labs and pathology groups. HIT Infrastructure also reported on rumors of Amazon branching into telemedicine using their Amazon Echo and Alexa platforms.
Security Concerns and Opportunities for Clinical Laboratories
According to Computerworld’s coverage of IDC research, by 2020, 25% of patients are expected to be taking part in ‘bring your own data” healthcare scenarios. Tech-savvy medical laboratories could find opportunities to interact directly with patients and encourage follow-through on test orders or follow-up on routine testing.
However, shifting protected health information to devices carried by consumers is not without risks.
“How do I know the data won’t make its way to some cloud somewhere to be shared, sold, etc.” Jack Gold, Principal Analyst with J. Gold Associates, told Computerworld. “And if I rely on an app to tell me what to do—say, take my meds—and it somehow gets hacked, can it make me sick, or worse?”
These are important questions and developments, which Dark Daily has covered in other recent e-briefings. (See, “Apple Updates Its Mobile Health Apps, While Microsoft Shifts Its Focus to Artificial Intelligence. Both Will Transform Healthcare, But Which Will Impact Clinical Laboratories the Most?” July 25, 2018.)
Nevertheless, with tech giants already developing products for the consumer market and healthcare provider industry, it’s a given consumers will soon gain greater access to their own healthcare information. Whether patients will ultimately embrace it, how they will use it, and how developers will interact with the data, is still undefined. But it’s coming and clinical laboratories should be prepared.
—Jon Stone
Related Information:
Apple to Launch Health Records App with HL7’s FHIR Specifications at 12 Hospitals
How Google, Microsoft, Apple Are Impacting EHR Use in Healthcare
Microsoft, Apple, Google Secure HIT Infrastructure Patents
How Big Tech Is Going after Your Health Care
Amazon Secret Healthcare IT Tech Team Focuses on EHRs, Alexa
Apple’s Health Record API Released to Third-Party Developers; Is It Safe?
Apple, Cerner and Microsoft Are Interested in Buying AthenaHealth: Here’s Why This CEO Says They Won’t
Apple Says iOS Health Records Has over 75 Backers, Uses Open Standards
Report: Health Systems Share Apple Health Records Feedback
Apple Is Officially in the EHR Business. Now What?
Why Apple’s Move on Medical Records Marks a Tectonic Shift
Slideshow Where the Top 8 EMRs Are Deployed
Apple Updates Its Mobile Health Apps, While Microsoft Shifts Its Focus to Artificial Intelligence. Both Will Transform Healthcare, but Which Will Impact Clinical Laboratories the Most?
Apple’s Update of Its Mobile Health App Consolidates Data from Multiple EHRs and Makes It Easier to Push Clinical Laboratory Data to Patients
Apr 6, 2018 | Compliance, Legal, and Malpractice, Digital Pathology, Laboratory Management and Operations, Laboratory News, Laboratory Operations, Management & Operations, News From Dark Daily
Softened FDA regulation of both clinical-decision-support and patient-decision-support software applications could present opportunities for clinical laboratory developers of such tools
Late 2017, the Food and Drug Administration (FDA) released guidelines on how the agency intends to regulate—or not regulate—digital health, clinical-decision-support (CDS), and patient-decision-support (PDS) software applications. The increased/decreased oversight of the development of these physicians’ tools could have important implications for anatomic pathology groups and clinical laboratories.
Physician decision-support software utilizes medical laboratory test data as a significant part of a full dataset used to guide caregivers. Thus, if the FDA makes it easier for developers to get regulatory clearance for these types of products, that could positively impact medical labs’ ability to service their client physicians.
Additionally, clinical pathologists have unique training in diagnosing diseases and understanding the capabilities and limitations of medical laboratory tests in supporting how physicians diagnose disease and make treatment decisions. Thus, actions by the FDA to make it easier for developers of software algorithms that can incorporate clinical laboratory data and anatomic pathology images with the goal of improving diagnoses, decisions to treat, and monitoring of patients have the potential to bring great benefit to the nation’s medical laboratories.
FDA Clarifies Role in Regulating CDS/PDS Applications
The new guidelines clarified items specified in the 21st Century Cures Act, which was enacted by Congress in December of 2016. This Act authorized $6.3 billion in funding for the discovery, development, and delivery of advanced, state-of-the art medical cures.
“Today, we’re announcing three new guidances—two draft and one final—that address, in part, important provisions of the 21st Century Cures Act, that offer additional clarity about where the FDA sees its role in digital health, and importantly, where we don’t see a need for FDA involvement,” FDA commissioner Scott Gottlieb, MD, Commissioner of Food and Drugs, noted in a statement. “We’ve taken the instructions Congress gave us under the Cures Act and [we] are building on these provisions to make sure that we’re adopting the full spirit of the goals we were entrusted with by Congress.”
Helping Doctors’ Decision-Making
The first guideline concerns clinical decision support systems that are designed to help doctors make data-driven decisions about patient care. The new guidelines make it easier for software developers to get regulatory clearance, which, the FDA hopes, will spark innovation and makes regulation more efficient.
“CDS has many uses, including helping providers, and ultimately patients, identify the most appropriate treatment plan for their disease or condition,” Gottlieb said in the FDA’s statement. “For example, such software can include programs that compare patient-specific signs, symptoms, or results with available clinical guidelines to recommend diagnostic tests, investigations or therapy.
“This type of technology has the potential to enable providers and patients to fully leverage digital tools to improve decision making,” Gottlieb continued. “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.”
Identifying Digital Health Applications That Receive/Don’t Receive FDA Oversight
The second guideline discusses and delineates which digital health applications are considered low risk and, thus, will not fall under FDA regulations.
Products that are not intended to be used for the diagnosis, cure, mitigation, prevention, or treatment of a condition will not be regulated by the FDA. These technologies are not considered medical devices and may include gadgets such as weight management and mindfulness tools. They can provide value to consumers and the healthcare industry while posing a low risk to patients.
“Similarly, the CDS draft guidance also proposes to not enforce regulatory requirements for lower-risk decision support software that’s intended to be used by patients or caregivers—known as patient-decision-support software (PDS)—when such software allows a patient or a caregiver to independently review the basis of the treatment recommendation,” Gottlieb noted in the statement.
Scott Gottlieb, MD (above), FDA Commissioner of Food and Drugs, noted in a statement, “We believe our proposals for regulating CDS and PDS not only fulfill the provisions of the Cures Act, but also strike the right balance between ensuring patient safety and promoting innovation. Clinical laboratories may find opportunities to work with CDS/PDS developers and support their client physicians. (Photo copyright: FDA.)
However, products that are intended to be used for the diagnosis, cure, mitigation, prevention, or treatment of a condition are considered medical devices and will fall under FDA regulations.
“The FDA will continue to enforce oversight of software programs that are intended to process or analyze medical images, signals from in vitro diagnostic devices, or patterns acquired from a processor like an electrocardiogram that use analytical functionalities to make treatment recommendations, as these remain medical devices under the Cures Act,” noted Gottlieb.
Items such as mobile apps that are utilized to maintain and encourage a healthy lifestyle are not deemed to be medical devices and will fall outside FDA regulations. The guidelines also defined that Office of the National Coordinator for Health Information Technology (ONC)-certified electronic health record (EHR) systems are not medical devices and, thus, will not be regulated by the FDA.
Software-as-a-Medical Device Gets FDA Oversight
The third guidance document deals with the assessment of the safety, performance, and effectiveness of Software as a Medical Device (SaMD).
“This final guidance provides globally recognized principles for analyzing and assessing SaMD, based on the overall risk of the product. The agency’s adoption of these principles provides us with an initial framework when further developing our own specific regulatory approaches and expectations for regulatory oversight and is another important piece in our overarching policy framework for digital health,” Gottlieb noted in the statement.
SaMD is defined by the International Medical Device Regulators Forum (IMDRF) as “software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device.”
Gottlieb noted that the three important guidance documents being issued would continue to expand the FDA’s efforts to encourage innovation in the ever-changing field of digital health. “Our aim is to provide more clarity on, and innovative changes to, our risk-based approach to digital health products, so that innovators know where they stand relative to the FDA’s regulatory framework. Our interpretation of the Cures Act is creating a bright line to define those areas where we do not require premarket review,” he concluded.
What remains to be seen is how the new FDA regulations will impact clinical laboratories and anatomic pathology groups. With the expanding interest in artificial intelligence (AI) and self-learning software systems, healthcare futurists are predicting a rosy future for informatics products that incorporate these technologies. Hopefully, with these new guidelines in place, innovative clinical laboratories will have the opportunity to develop new digital products for their clients.
—JP Schlingman
Related Information:
FDA Softens Stance on Clinical-decision Support Software
Clinical and Patient Decision Support Software
FDA Issues New Guidance for Clinical and Patient Decision Support Software
Statement from FDA Commissioner Scott Gottlieb, M.D., on Advancing New Digital Health Policies to Encourage Innovation, Bring Efficiency and Modernization to Regulation
FDA Issues Three Guidances, Including Long-awaited CDS Guidelines
The Feds Just Cleared a Major Roadblock for Digital Health
FDA Unveils Clinical Decision Support, Medical Device Guidance
