Today, the U.S. Department of Health and Human Services (HHS) announced it is extending the public comment period by 30 days for two proposed regulations aimed at promoting the interoperability of health information technology (health IT) and enabling patients to electronically access their health information. The new deadline for the submission of comments – June 3, 2019 – will allow additional time for the public to review the proposed regulations.
The extension of the public comment period coincides with a release by the HHS Office of the National Coordinator for Health Information Technology (ONC) of the second draft of the Trusted Exchange Framework and Common Agreement, along with a related Notice of Funding Opportunity. HHS also today released of a set of frequently asked questions (FAQs) from the Office for Civil Rights (OCR).
The FAQs address the Health Insurance Portability and Accountability Act (HIPAA) right of access as it relates to apps designated by individual patients and application programming interfaces (APIs) used by a healthcare provider’s electronic health record (EHR) system. The FAQs clarify that once protected health information has been shared with a third-party app, as directed by the individual, the HIPAA covered entity will not be liable under HIPAA for subsequent use or disclosure of electronic protected health information, provided the app developer is not itself a business associate of a covered entity or other business associate.
On February 11, 2019, HHS announced two proposed rules to support the seamless and secure access, exchange, and use of electronic health information (with Federal Register publication on March 4, 2019). The rules would increase choice and competition while fostering innovation that promotes patient electronic access to and control over their health information. Together the proposed rules address both technical and healthcare industry factors that create barriers to the interoperability of health information and limit a patient’s ability to access essential health information. Addressing those challenges will help to drive an interoperable health IT infrastructure across systems, enabling healthcare providers and patients to have access to health data when and where it is needed.
This extension responds to requests from a variety of stakeholders, including healthcare provider organizations and industry representatives. The Centers for Medicare & Medicaid Services (CMS) and ONC understand that both rules include a range of issues having major effects on healthcare. The extension of the public comment deadline will maximize the opportunity for meaningful input and further the overall objective to obtain public input on the proposed provisions to move the healthcare ecosystem in the direction of interoperability.
For more information on the Trusted Exchange Framework and Common Agreement and the Notice of Funding Opportunity, visit: https://www.healthit.gov/TEFCA
The U.S. Department of Health and Human Services (HHS) today issued for public comment draft two of the Trusted Exchange Framework and Common Agreement (TEFCA) that will support the full, network-to-network exchange of health information nationally. HHS also released a notice of funding opportunity to engage a non-profit, industry-based organization that will advance nationwide interoperability.
Specifically, the documents being released for comment are: (1) a second draft of the Trusted Exchange Framework (TEF), (2) a second draft of the Minimum Required Terms and Conditions (MRTCs) for trusted exchange, and (3) a first draft of a Qualified Health Information Network (QHIN) Technical Framework. These documents will form the basis of a single Common Agreement that QHINs and their participants may adopt. This Common Agreement will create baseline technical and legal requirements for sharing electronic health information on a nationwide scale across disparate networks.
Alex Azar
“The seamless, interoperable exchange of health information is a key piece of building a health system that empowers patients and providers and delivers better care at a lower cost,” said HHS Secretary Alex Azar. “The 21st Century Cures Act took an important step toward this goal by promoting a national framework and common agreement for the trusted exchange of health information. We appreciate the comments and input from stakeholders so far and look forward to continued engagement.”
In developing a TEFCA that meets industry’s needs, HHS’ Office of the National Coordinator for Health Information Technology (ONC) has focused on three high-level goals:
Provide a single “on-ramp” to nationwide connectivity;
Ensure electronic information securely follows you when and where it is needed; and
Support nationwide scalability for network connectivity.
ONC will maintain the TEF, while a non-profit, industry-based organization, known as the Recognized Coordinating Entity (RCE), will be awarded funds to develop, update, implement, and maintain the Common Agreement. Through this effort, ONC will define the minimum required terms and conditions needed to bridge the current differences among data sharing agreements that are preventing the flow of electronic health information. The industry-based RCE will be tasked with developing additional required terms and conditions necessary to operationalize the Common Agreement and meet the interoperability requirements of the 21st Century Cures Act.
What causes two patients of the same age and with the same disease but from different regions to respond differently to a certain treatment? Even if these two patients appeared similar on paper, their lifestyles are very likely to differ — socioeconomic status, gender, race, ethnicity, family structure and education.
Is SDOH a promise for a better future, or is it just another hype?
Success in the value-based care environment cannot be achieved based solely on clinical insights. According to one study, clinical care accounts for only 20 percent of the health outcomes of patients, while health behaviors, social and economic factors, and physical environment combined add up to in?uence the remaining 80 percent of health outcomes.
Social determinants matter because they can affect the health of the population residing in a particular region for better or for worse. Trying to improve population health armed with only clinical data and not the non-clinical factors, is like investing in a project which cannot generate positive returns.
Although multiple pieces of research demonstrate that social determinants may substantially contribute to a person’s health status and well-being, the major problems are these:
How do we address these complex challenges?
Who is the best-positioned stakeholder to do so in a clinical environment?
What is the right way to address these social determinants?
The Centers for Disease Control and Prevention (CDC) has defined an algorithm to estimate the Social Vulnerability Index (SVI) for every census-tract in the US. However, this algorithm is based on a simple summation of the percentile ranks for all SDOHs, which results in an over-estimation of social vulnerability in cases of high positive correlation between multiple SDOHs.
Working with SDOH data requires a more drilled-down approach and the use of predictive analytics to accurately measure the at-risk population and to advance preventive care methods in an ecosystem.
The right approach is to start from a state-level analysis and drill down to the zip code-level. The effects of social determinants vary in accordance with a very small region. There is a high possibility that all the zip codes in a county will have different susceptibility to a particular social determinant.
What new ways can a revolutionary approach to SDOH open for healthcare?
Every social determinant affects the region in its own way and corresponding preventive actions need to be taken in order to overcome the adverse health outcomes of the citizens of that region. For instance, community resources and data needs to be integrated into the care coordination processes to make proper interventions. When providers are able to completely understand the effects of non-clinical factors, they can provide much better care to their patients.
The analysis of social determinants can be applied for multiple use cases such as:
Identifying the role of behavioral health, social workers and health coaches
Increasing the efficiency of the care coordination team
Forging better partnerships with community resources and social improvement funding agencies, and many more.
The road ahead
Though providers have recognized that social factors significantly influence their patients’ health, they are often unaware of their patients’ social vulnerabilities and are unable to accept responsibility for managing these issues or providing support to their patients outside of the clinical realm. We are stepping into the age of predicting and preventing diseases instead of curing them. That was the traditional approach. With non-clinical data and resources such as SDOH, we can change the future of US healthcare. All we need is the will to right these wrongs.
By Bentley Raynott, healthcare technology analyst, Tatvasoft.
With the advent of new technologies, the entire healthcare industry is gearing up to adopt new initiatives. Marked with different growth patterns and trends that could vary within its different sub-domains, the industry seems to have witnessed a couple of contradicted situations with inconsistent stagnation in others. The following post sums up certain trends to watch out in the development and data-driven technologies to take into account.
Artificial intelligence
Over the past few years, artificial intelligence, machine learning, big data technologies have shown a prolific growth like never before. For example, IBM Watson — an AI-based system seems to have enhanced core management, accelerated drug discovery, matched patients with clinical trials, and fulfill other tasks. It is considered as one of those systems that have aided several medical institutions saving a great deal of time and money in the future. It is assumed that in 2019 and all the upcoming years, AI will become more advanced and will be carrying a wider range of tasks without human monitoring. Here are some predictions of AI trends in healthcare.
Early diagnosis
Having a patient-centric approach has become a norm these days. A unique radical change in the set of expectations that a consumer has today. Do you feel that front end challenges has the potential to suffice the need for consumerism especially in regards to the diagnostic aspect of patient care? Well, several diagnostic entities are found embracing the superior methods through which they can stay ahead in the value-driven system.
It may interest you to know that some of the major pharma players are seen investing in the consumer genetics field for the development of novel pharmaceutical products. As a result, GlaxoSmithKline entered into a four-year collaboration with 23andMe; one of the leading players in the genetic testing market; for drug discovery through human genetics.
Being in the healthcare sector, clinical decision-making is expected to advance in order to provide simple, standardized, effective and efficient across the care spectrum focusing on prevention, illness, and chronic care wellness, by virtue of a comprehensive strategy such as consumer genomics and precision medicine.
Gene editing technologies will advance
This technology, especially in the diagnostic platform, are making to change the face of disease detection, bio-sensing, and diagnostics in the years and many more. Moreover, it can also prove equally viable in the field of agriculture, biomanufacturing and forensics.
The Centers for Medicare & Medicaid Services (CMS) released the final annual Notice of Benefit and Payment Parameters for the 2020 benefit year, also known as the 2020 Payment Notice. The rule reduces user fees for plans offered on HealthCare.gov, and encourages the use of lower-cost generic drugs, while improving market stability and consumer choice.
“The rule issued today will give consumers immediate premium relief for 2020 by reducing the federal Exchange user fees thanks to successful efforts to improve the efficiency of the Exchange,” said CMS Administrator Seema Verma. “At CMS we have improved the operations of the Exchange to deliver a better consumer experience at a lower cost.”
Generally, Exchange user fees are passed directly on to the consumer in the form of higher premiums, and this reduction in the user fee allows issuers to pass along savings to consumers in 2020. The 0.5 percent reduction in the user fee rate comes as a result of CMS’ focus on reducing costs through increased operational efficiency, including successful efforts to upgrade IT functionality, a more efficient approach to outreach, and investments focused on proven methods to achieve a seamless enrollment experience and high consumer satisfaction.
This follows the first ever 1.5 percent drop in average premiums for plans selected through HealthCare.gov for the 2019 coverage year. With consumers facing rising premiums and limited choice in their health coverage leading up to 2017, the Trump Administration introduced a series of actions to encourage competition and bring down the price of healthcare for people in the individual market. The final 2020 Payment Notice builds on these prior actions to further strengthen America’s health insurance markets.
Building on the President’s American Patients First blueprint, the final rule also supports lower premiums by promoting the use of lower-cost generic drugs. Drug companies can offer consumers coupons to incentivize them to purchase the company’s brand name drugs even when an appropriate, less-expensive generic medication is available. This rule allows issuers to stop applying the value of these coupons towards an enrollee’s maximum-out-of-pocket costs in situations where a generic medication is available and medically appropriate, in order to encourage generic use and result in lower drug spending.
To improve market stability, a key element of this final rule refines the risk adjustment program to improve the accuracy of the data used to calculate the program’s charges and payments to issuers. This program is designed to reduce incentives for insurers to avoid enrolling people with expensive health conditions. The rule finalizes several proposals regarding the validation of the accuracy of the diagnosis codes, prescription drug data and codifies a number of exemptions to lessen burden on small issuers.
This rule also aims to increase the choices available to consumers for trusted enrollment pathways. Last fall CMS successfully launched Enhanced Direct Enrollment (EDE), which allows consumers to shop for and enroll in the Exchange plan of their choice through an approved partner website. In regards to enrollment, the final rule streamlines and updates regulations to accommodate future innovation and improve the consumer experience.
The EDE pathway allows CMS to partner with the private sector to provide a more user-friendly and seamless enrollment experience for consumers by allowing them to apply for, and enroll in, an Exchange plan directly through an approved issuer or web-broker without the need to be redirected to HealthCare.gov. In recognition of the new pathway, the final rule increases transparency as well as the privacy and security of consumer data by allowing CMS to require web-brokers to provide lists of the agents and brokers who use their websites.
The rule also enhances consumer protections and improves program integrity by allowing CMS to more easily suspend or terminate agents, brokers and web-brokers that violate applicable Marketplace requirements. As EDE continues to expand, to guarantee consumers continue to receive a high level of service, being able to more easily suspend or terminate agents, brokers and web-brokers that violate rules will better enable CMS to ensure agent/broker and web-broker compliance, respond to cases of noncompliance, and to protect sensitive Exchange data and systems.
Further, the rule finalizes a technical change to the premium index for the 2020 benefit year in order to better align our premium adjustment percentage methodology with the experience of the individual markets and premiums overall. Under the new methodology, CMS would use the CMS Office of the Actuary (OACT) estimates of projected health insurance premiums for both the private individual and group market (excluding expenditures for Medigap and property and casualty insurance). This change would replace the current methodology which utilizes only employer-sponsored group market insurance (ESI) premiums, which do not reflect the situation of the individual market premiums. This technical change in the premium adjustment percentage methodology will provide a more comprehensive and accurate measure of private market premiums.
Today, CMS also issued the Final 2020 Letter to Issuers in the FFE which provides guidance to issuers that want to offer Qualified Health Plans (QHPs) on the FFE, as well as the Key Dates Charts for the 2019 Calendar Year.
A foundational research roadmap for artificial intelligence (AI) in medical imaging was published this week in the journal Radiology. The report was based on outcomes from a workshop to explore the future of AI in medical imaging, featuring experts in medical imaging, and hosted at the National Institutes of Health in Bethesda, Maryland. The workshop was co-sponsored by the National Institute of Biomedical Imaging and Bioengineering, the Radiological Society of North America, the American College of Radiology, and the Academy for Radiology and Biomedical Imaging Research.
The collaborative report underscores the commitment by standards bodies, professional societies, governmental agencies, and private industry to work together to accomplish a set of shared goals in service of patients, who stand to benefit from the potential of AI to bring about innovative imaging technologies.
The report describes innovations that would help to produce more publicly available, validated and reusable data sets against which to evaluate new algorithms and techniques, noting that to be useful for machine learning these data sets require methods to rapidly create labeled or annotated imaging data. The roadmap of priorities for AI in medical imaging research includes:
new image reconstruction methods that efficiently produce images suitable for human interpretation from source data,
automated image labeling and annotation methods, including information extraction from the imaging report, electronic phenotyping, and prospective structured image reporting,
new machine learning methods for clinical imaging data, such as tailored, pre-trained model architectures, and distributed machine learning methods,
machine learning methods that can explain the advice they provide to human users (so-called explainable artificial intelligence), and
validated methods for image de-identification and data sharing to facilitate wide availability of clinical imaging data sets.
Article
Langlotz, CP, et al. A Roadmap for Foundational Research on Artificial Intelligence in Medical Imaging: From the 2018 NIH/RSNA/ACR/The Academy Workshop. Radiology. April 16, 2019.
Co-authors of the report with Curtis P. Langlotz were Bibb Allen, M.D.; Bradley J. Erickson, M.D., Ph.D.; Jayashree Kalpathy-Cramer, Ph.D.; Keith Bigelow, B.A.; Tessa S. Cook, M.D., Ph.D.; Adam E. Flanders, M.D.; Matthew P. Lungren, M.D., M.P.H.; David S. Mendelson, M.D.; Jeffrey D. Rudie, M.D., Ph.D.; Ge Wang, Ph.D.; and Krishna Kandarpa, M.D., Ph.D.
Telehealth is a really exciting field with masses of opportunity to build successful companies and to help people quite literally all across the globe. Technology has afforded us the opportunity to administer all sorts of things at vast distances and now that includes medical help. It’s not a field without some issues though and plenty of people will find getting into telehealth quite complex and confusing. So, here are a few tips for starting out in this industry.
Pick an appropriate field
Telemedicine is limitless in some ways, limited in others. This is an area with some limitations. “There are only certain sorts of medicine which it is practical to apply to the telehealth model, not to mention legally speaking,” warns Shane Marlon, career manager at PaperFellows and AustralianReviewer. You have to be able to guarantee that whatever it is you are doing will be of use without needing an ‘in-the-flesh’ consultation. But you’ll be surprised at how long that list of applicable practices is!
Look to the future
Tech development moves very, very quickly so it’s safe to say that telehealth, as a rising industry, will look completely different in ten years’ time. Now, you’re not a prophet, nor are you a trend-predicting supercomputer. However, with a little research you will quickly ascertain which elements of telehealth are set to change and develop. To capitalize effectively on these when the time comes, you need to be preparing now. For example, more detailed consultations of patients will be possible in the future, so the list of applicable fields will increase, and you need to be ready for that.
Find telehealth professionals
Though it is a relatively new field, there are already telehealth specialists who are out there. These people will be immensely useful to you as you try and develop in the industry. It’s vital that you bring in some outside expertise into your team as you develop, since it is such a new field with so few precedents in place to ensure that you are doing the right things.
What if, in an emergency, you reach for your epinephrine shot and it’s not there? It would be if you were wearing it.
Rice University students have designed a small, foldable epinephrine delivery device meant to be worn on a wrist, like a watch, or elsewhere on the body by a person at risk of an allergic reaction that requires an immediate response.
The tri-fold device they call EpiWear has a unique, spring-activated injection system that would provide a full dose of the drug to a person experiencing an allergic reaction.
The team – junior bioengineering majors Albert Han, Alex Li, Jacob Mattia and Justin Tang, and freshman Callum Parks – said the device is intended for all but small children, and could be a good alternative to other delivery systems on the market.
“The idea came from me, because I suffer peanut allergies,” said Tang, who worked on the device at the Brown School of Engineering‘s Oshman Engineering Design Kitchen with adviser and Rice lecturer Deirdre Hunter. “I’m very self-aware and worried about my life, but it was always difficult for me to bring something as bulky and obtrusive as this when going to dinner with friends or just going out at night.”
Tang held up the pen-like syringe he carries in case of emergency. Such pens were the focus of controversy a few years ago when Congress held a hearing on the sharply rising price of the devices.
The Rice team hopes its creation will lead to a delivery device that is less expensive, more stylish and thus more likely to be worn by users.
“We designed the optimal device to house the minimal amount of epinephrine necessary for injection,” Mattia said, holding a scaled-up prototype.
EpiWear is designed to inject a dose of 0.3 milliliters of epinephrine, the same as commercial devices that contain more of the drug.
“They actually only inject a fraction of what they hold,” Li said.
Today, the U.S. Department of Health and Human Services (HHS) announced it is extending the public comment period by 30 days for two proposed regulations aimed at promoting the interoperability of health information technology (health IT) and enabling patients to electronically access their health information. The new deadline for the submission of comments – June 3, 2019 – will allow additional time for the public to review the proposed regulations.
With the advent of new technologies, the entire healthcare industry is gearing up to adopt new initiatives. Marked with different growth patterns and trends that could vary within its different sub-domains, the industry seems to have witnessed a couple of contradicted situations with inconsistent stagnation in others. The following post sums up certain trends to watch out in the development and data-driven technologies to take into account.
The Centers for Medicare & Medicaid Services (CMS) released the final annual Notice of Benefit and Payment Parameters for the 2020 benefit year, also known as the 2020 Payment Notice. The rule reduces user fees for plans offered on HealthCare.gov, and encourages the use of lower-cost generic drugs, while improving market stability and consumer choice.
What if, in an emergency, you reach for your epinephrine shot and it’s not there? It would be if you were wearing it.