Expanding FCC connected health programs. FCC Chairman Ajit Pai in his keynote reinforced the agency’s interest and support of connected health initiatives, from rural to opioids. Most of the programs have a rural focus to bring broadband and telehealth/RPM to the ‘end of the line’ in underserved communities, something close to Mr. Pai’s heart as his parents were both rural physicians in Kansas..
- This summer, the Connected Care Pilot Program was proposed and approved unanimously in August [TTA 9 Aug]. Funding for this is proposed at $100 million.
- The spending cap for the rural healthcare program, which has been around since 1997’s dial-up days and now includes telemedicine and remote monitoring, was increased for 2017-2018 from $400 million to $571 million, a 43 percent increase. The FCC has pledged to fully fund 2018 programs.
- New initiatives were announced covering new uses for telehealth and remote patient monitoring:
- Connected care at home via RPM as part of the Connected Care Pilot Program
- Cancer care in partnership with the National Cancer Institute. The Launch program for rural and underserved communities aims to bring high-quality cancer care to where patients work and live through bringing together government, academia and community health providers.
- For opioids, there are two programs. One is expanding the mapping broadband health platform to include critical drug use data. This will allow users to rapidly visualize, overlay, and analyze broadband and opioid data together at the national, state, and county level. The second is to launch a chronic pain management and opioid use challenge as part of the pilot program. Mobihealthnews
A status report on NIH’s All of Us. Back in January as part of setting the stage for 2018, this Editor briefly mentioned the National Institute of Health’s massive All of Us program, part of the Federal Precision Medicine Initiative (PMI). All of Us needs almost all of us–their goal is to collect data on at least one million Americans for a major leap forward on data supporting population health. Dr. Dara Richardson-Heron, All of Us’ chief engagement officer, confirmed that over 100,000 participants have registered since the launch in May, with over 65,000 completing the full protocol. She mentioned that 75 percent of signups are from groups often underrepresented in modern medical research, with 50 percent from racial and ethnic minorities. The Mobihealthnews article ends on a ‘Debbie Downer’ note of doubting whether the program will reach enrollment goals, the cost will be justified, and whether the data will be kept private as promised.
MIT’s social robots may be the future of emotional support for wellbeing. MIT associate professor Cynthia Breazeal heads up the Personal Robots Group and is working on how to integrate AI into emotional robots for pediatric patients at Boston Children’s Hospital. The robots serve as a go-between child life specialists and the patient. The initial results were positive, with higher verbal scores (as a measure of engagement) than with stuffed bears or digital avatars. Professor Breazeal wants to extend the technology to older adults for wellbeing and engagement. Running against the conventional wisdom, their research found that older adults were more open to technology than the children. Following MIT’s work are companies like Hasbro and Embodied. Mobihealthnews.
The Federal Communications Commission (FCC) moved relatively quickly to approve the Connected Care Pilot Program, approving broadband-enabled telehealth and remote patient monitoring services in underserved rural and remote areas. Funding for the program has been pegged at $100 million. The approval was unanimous on the program proposed by FCC commissioner Brendan Carr and Mississippi Sen. Roger Wicker.
CCPP will provide $100 million for subsidies to hospitals or wireless providers running post-discharge remote monitoring programs for low-income and rural Americans. An example is those run by the University of Mississippi Medical Center. The goal is to lower same-cause readmissions and improve patient outcomes. [TTA 13 July] Hearings late last month also were structured to support the program and start to fill out the details for a 2019 start [TTA 1 Aug].
Public comments are now open for a 2019 start to the program (see FCC website–look under Connect2Health which is the umbrella site for this and similar programs). Commissioner Carr had to look no further than the VA to see how Home Telehealth and other remote monitoring programs worked to drive down cost and improve patient outcomes. VA Health’s remote monitoring program cost $1,600 per patient compared to $13,000 for traditional care in one study. The trick is now translating this into an open system.
This is a nice boost to both real-time video and asynchronous remote patient monitoring in market development (and getting paid) in areas of great need. It’s also another Federal signal (so to speak) for 2019, following the proposed Medicare Physician Fee Schedule’s increased payments and broader applicability for both. mHealthIntelligence, Mobihealthnews, FCC Release Hat tip to reader Paul Costello of Medopad.
[grow_thumb image=”http://telecareaware.com/wp-content/uploads/2017/12/Lasso.jpg” thumb_width=”125″ /]FCC backs post-discharge RPM plan.
The “Connected Care Pilot Program” proposed by FCC commissioner Brendan Carr would provide $100 million for subsidies to hospitals or wireless providers running post-discharge remote monitoring programs for low-income and rural Americans such as those run by the University of Mississippi Medical Center. The goal is to lower readmissions and improve patient outcomes. The proposal still needs to be formalized so it would be 2019 at earliest. POLITICO Morning eHealth
, Clarion-Ledger, Mobihealthnews
NHS Digital’s 150,000 patient data breach originated in a coding error in the SystmOne EHR used by GPs. Through the error by TPP, SystmOne did not recognize the “type 2 opt-out” for use of individual data in clinical research and planning purposes. This affected records after 31 March 2015. This breach also affects vendors which received the data, albeit unknowingly, but the duration of the breach makes it hard to put the genie back in the bottle, which NHS Digital would like to do. Inforisktoday, NHS Digital release
Unstructured data in EHRs more valuable than structured data in older adult patient health. A new study in the Journal of the American Geriatrics Society compared the number of geriatric syndrome cases identified using structured claims and structured and unstructured EHR data, finding that the unstructured data was needed to properly identify geriatric syndrome. Over 18,000 patients’ unstructured EHR notes were analyzed using a natural language processing (NLP) algorithm.
Cerner buying a share in population health/value-based care management company Lumeris through purchasing $266 million in stock in Lumeris parent Essence Group Holdings. The angle is data crunching to improve outcomes for patients in Medicare Advantage and other value-based plans. Lumeris also operates Essence Healthcare, a Medicare Advantage plan with 65,000 beneficiaries in Missouri. Fierce Healthcare
NHS Digital awarding £240,000 for investigating social care transformation through technology. The Social Care Digital Innovation Programme in 12 councils will be managed by both NHS and the Local Government Association (LGA). Projects to be funded span from assistive technologies to predictive analytics. Six winners from the original group of 12 after three months will be awarded up to a further £80,000 each to design and implement their solutions. New Statesman
Curious about RFID in use in healthcare, other than in asset management, access, and log in? Contactless payments is one area. As this is the first of four articles, you’ll have to follow up in Healthcare IT News
Hot Air Relief Here. There’s been much of it expended on the so-called ‘net neutrality’ issue which can be summarized as follows: The Federal Communications Commission (FCC) is getting out of treating internet service providers (ISPs) like broadcast carriers, returning ISP speed/access enforcement to the Federal Trade Commission (FTC) as it was in 2015. Developments around 5G data and faster ISP speeds made the FCC’s involvement resemble a relic of the 1960s ‘vast wasteland’ FCC which imposed ‘equal time’ and content restrictions on broadcasters which were in effect through the 1980s and even into the 1990s. It’s taken our attention in healthcare away from FCC’s pertinent work in expanding the Rural Health Care program which covers some of the costs of broadband service for rural health care providers.
On the 15th, the FCC adopted a notice of proposed rulemaking (NPRM) which triggers comment on the Rural Health Care program rule changes, importantly an increase in the present $400 million cap. It also gives a one-time funding boost by carrying forward previously unused funds. Telecompetitor is succinct on the rule changes and commissioners’ comments, some of which point to certain providers overbuilding capacity, the number of providers in the program has actually decreased, and that the point of it is to make service more affordable. FCC Release, Notice of Proposed Rulemaking, Full listing of documents This may also stimulate private-public efforts such as Microsoft’s which attempt to close the rural digital connectivity gap through innovations such as the Rural Airband Initiative and utilization of TV white spaces [TTA 22 Aug].
Here’s some more FCC Good News. The Connect2Health Task Force and the National Cancer Institute announced a few days earlier that they are jointly working in the Appalachia region of Kentucky to study the relationship between better broadband and improved cancer care for patients in critical need counties. Appalachia is one of the poorest rural areas in the US with soaring cancer mortality. Only about half the state of Kentucky has internet and about 20 percent cannot access at all. The FCC is also inviting fixed or mobile broadband providers, health technology companies, device manufacturers, and healthcare facilities―to contact the Task Force. The project is Linking & Amplifying User-Centered Networks through Connect Health (LAUNCH): A Demonstration of Broadband-Enabled Health for Rural Populations in Appalachia. mHealth Intelligence, FCC Release
[grow_thumb image=”http://telecareaware.com/wp-content/uploads/2017/08/Radio-tower.jpg” thumb_width=”100″ /]The digital divide comes one step closer to closing. Microsoft’s release of its white paper proposing an alternative to the expensive build-out of the US broadband network deserved more attention than it received in July. The Rural Broadband Strategy combines TV white spaces spectrum (the unused UHV television band spectrum in the 600 MHz frequency range which can penetrate through walls, hilly topography, and other obstacles) with fixed wireless and satellite coverage to economically deliver coverage to un/under-served areas versus fiber cable (80 percent savings) and LTE fixed wireless (50 percent).
34 million Americans lack broadband connection to the internet. Some of these are voluntary opt-outs, but 23.4 million live in rural areas without access, with huge economic consequences estimated in the hundreds of billions. TV white spaces can also expand coverage in small cities and more densely populated areas, including usages such as within buildings. This effort also presses the FCC, which in turn has pressed for broadband for two decades, to ensure that at least three channels below 700 MHz are kept unlicensed in all markets in the US, with more TV white spaces for rural areas.
The first part, the Rural Airband Initiative, builds on Microsoft’s present 20 programs worldwide, and is planned to connect 2 million people in by July 4, 2022, with 12 projects across the US running in the next 12 months. Much of the connectivity is dedicated to nonprofit efforts like 4-H’s digital literacy program and ‘precision agriculture’ in New York State and Washington. Microsoft is also granting royalty-free access to 39 patents and sample source code related to white spaces spectrum use in rural areas.
A positive move for telehealth’s spread. Rural healthcare providers pay up to three times as much for broadband as their urban counterparts. Telemedicine increasingly connects for consults between hospitals in rural areas and city-based health systems for specialty coverage and to provide assistance in specialized medical procedures. Telemedicine and telehealth remote monitoring has difficulty spreading with poor internet coverage; this has already been a barrier to patients in rural ACOs who can be 1-2 hours from the doctor’s office and notably for the VA in providing rural veterans with home telehealth support. Paramedics increasingly rely on internet connections and dropped connections lead ambulances to go to hospitals at a greater distance. If the FCC cooperates and Microsoft’s partners can find a way to profitably execute, broadband can finally achieve that promise about closing the ‘digital divide’ made back in the Clinton Administration. A Rural Broadband Strategy: Connecting Rural America to New Opportunities The Verge, mHealth Intelligence, Becker’s Hospital Review
In last week’s Senate subcommittee hearings on the Federal Communications Commission (FCC)’s Universal Broadband Fund and Rural Healthcare (RHC) program, the University of Virginia’s Center for Telehealth chalked up some substantial results confirming the effectiveness of telemedicine in rural areas. In advocating further funding for an expansion of the program, they presented the following:
- A 40 percent reduction in 30-day same cause hospital readmissions for patients with heart failure, acute myocardial infarction, chronic obstructive pulmonary disease, pneumonia, stroke, and joint replacement
- It enabled over 65,000 live interactive patient consultations and follow-up visits with high definition video within 60 different clinical subspecialties
- Their home remote monitoring program included over 3,000 patients and screened more than 2,500 patients with diabetes for retinopathy
- UVA delivered 100,000 teleradiology consults and provider-to-provider consults supported by the Epic EHR.
The UVA analysis also quantified travel savings in areas where medical and hospital care can be hours away–17 million miles of rural travel including 200,000 miles by high-risk pregnant mothers. For these mothers, NICU hospital days for the infants born to these patients were reduced by 39 percent compared to control patients and patient no-shows by 62 percent.
Karen Rheuban, MD, director and co-founder of the UVA Telehealth Center, recommended that the FCC continue to fund the RHC’s $400 million budget, with the caveat of exploring additional federal revenues should that budget be reduced. She also recommended that Medicaid and Medicare reimbursement for telehealth services be increased, the addition of wireless technologies, and including emergency providers and community paramedics in RHC funding. mHealth Intelligence, Subcommittee information and hearing video (archived webcast)
The Federal Communications Commission (FCC) has been investigating [grow_thumb image=”http://telecareaware.com/wp-content/uploads/2016/08/C2H-BroadbandMap_Gaps-America.png” thumb_width=”150″ /]the relationship between broadband and health in the US through their Connect2Health Task Force and this week it has released an online tool “Mapping Broadband Health in America”.
It is an interactive map that allows users to visualise, overlay and analyse broadband and health data at the national, state and county levels.
This tool allows easy access to existing health and broadband access data to anyone who wants to look at the possible influence of broadband access on health over a period of time or to identify gaps which may provide opportunities to develop or expand online health services.
The interactive tool allows the user change the broadband availability measure (by say proportion of coverage or download speed for example) and select a health measure such as say obesity rate or preventable hospitalisation days and shows where the selected broadband measure is satisfied, where the selected health measure is satisfied and where both are satisfied. The types of health measures are currently limited but if users find the tool useful and feedback to the FCC there may well be further expansion.
Have a play with the map here.
In contrast to last week’s deletion of telemedicine by the House Energy and Commerce committee from ’21st Century Cures’, this past Tuesday’s Senate Commerce subcommittee on Communications hearing was far more cheering for both telehealth and telemedicine advocates. More than twelve Senators spoke on behalf of telehealth expansion, especially Medicare reimbursement for telehealth in rural areas where there is limited care access. Holding this expansion back, according to iHealthBeat, are four factors: the limited cross-state licensing for physicians; the sluggishness of the Federal Communications Commission–despite initiatives such as Connect2HealthFCC [TTA 6 Mar 14], the FCC has blocked subsidies for nursing home broadband; reimbursement and limited broadband access in the same rural areas (more…)
Another part of the 2012 FDA Safety and Innovation Act (FDASIA) clicked into place with the US Department of Health and Human Services (HHS) publishing a draft report proposing strategy and recommendations for what is rather grandly termed a “health IT framework”. Basically it defines more unified criteria, based on risk to the patient and function of what the device does, not the platform (mobile, software, etc.). It then separates products into three broad categories. Excerpted from the FDA release and the FDASIA Health IT Report:
- Products with administrative health IT functions, which pose little or no risk to patient safety and as such require no additional oversight by FDA. Examples: billing software, inventory management.
- Products with health management health IT functions. Examples: software for health information and data management, knowledge management, EHRs, electronic access to clinical results and most clinical decision support software. This will be coordinated largely by HHS’s Office of the National Coordinator for Health IT (ONC) as part of their activities (including their current voluntary EHR certification program), but the private sector is also cited in establishing best practices.
- Products with medical device health IT functions, which potentially pose greater risks to patients if they do not perform as intended. Examples: computer-aided detection software, software for bedside monitor alarms and radiation treatment software. The draft report proposes that FDA continue regulating products in this last category. (Illustration on page 13 of report.)
The report also recommends the creation of a public-private entity under ONC, the Health IT Safety Center, which “would serve as a trusted convener of stakeholders and as a forum for the exchange of ideas and information focused on promoting health IT as an integral part of patient safety.” The private sector is duly noted as a ‘stakeholder’.
The report was developed by FDA “in consultation” with ONC and, not unexpectedly, the Federal Communications Commission (FCC). Another recommendation (page 28) is the establishment of a ‘tri-Agency memorandum of understanding (MOU)’ to further determine their working relationship in this area. There’s a 90 day comment period on the 34 page report, which is perfect for weekend reading (!) How this onion will eventually be peeled, rather than quartered, remains to be seen, as does anything emanating from Foggy Bottom. FDA release. Report. FierceMobileHealthcare.
Update 8 April: A good summary of criticism and approval of the framework to date appears in iHealthBeat from the California Health Care Foundation. The two US Senators sponsoring the PROTECT Act [TTA 28 Feb, 6 Mar] stated there is still too much regulation of low-risk technologies, and Bradley Thompson of Epstein Becker/mHealth Regulatory Coalition believes the report is weak on the issues around clinical decision support software. With praise: HIMSS, Health IT Now Coalition and ACT, which claims to represent about 5,000 mobile application developers and IT firms, but has no locatable website.
Previously in TTA: FDA finally issues proposed rule simplifying medical device classification
That other three-letter agency, the Federal Communications Commission (FCC), which has shown a distinctly competitive face versus the FDA on Federal healthcare tech policy over the past three years and more, has formed–drum roll–a task force to examine adoption of wireless technologies by health care organizations. Connect2HealthFCC will “identify regulatory barriers and incentives to expand the use of wireless health technologies; and strengthen partnerships with stakeholders in the telehealth and mobile health industries.” If this an accurate statement of the task force’s purpose, the parade not only has gone by, but it’s also three counties away. Yet going back in our files, this Editor notes that the FCC has vigorously fenced not only with the FDA, but also with HHS, NIH, NIST and Congress for its place in the Federal HIT regulatory firmament. With issues such as ‘net neutrality’, wireless bandwidth and rural broadband, the FCC has a heaping healthcare helping on its plate just in assuring national access and removing conflicts in frequency demands by devices. However, the task force is headed by Michele Ellison, lately the FCC’s top regulatory enforcer with, as The Hill notes, 6,000 actions under her belt. In Foggy Bottom, things are never what they seem. iHealthBeat
With its recent decision in ending ‘net neutrality’ as directed in the FCC‘s 2010 Open Internet Order, the (Washington) DC Circuit Court of Appeals has changed the playing field for mHealth. The FCC regulation treated internet service providers (ISPs) like telecommunications companies by enforcing telecom ‘common carriage’ requirements that prevented ISPs from blocking or discriminating against types or providers of internet traffic. The current situation is now a double-edged sword for the ISPs: on one edge, ISPs such as Verizon, Comcast or Charter won, because they now can charge fees to, slow down or demand revenue sharing of high-demand content originators (Netflix) which also use a lot of bandwidth; the other edge is that the court affirmed that the FCC regulates the relationship between the two.
The meaning for mHealth? The amount of health data carried over the internet is growing exponentially and dependent on speed. If internet carriage can be held up for small providers to make way for high-paying content, it can and will change the revenue model for mHealth. From clinicians to fitness buffs, everyone wants their data right now. It may impact lower-income people and home health which uses internet tracking for healthcare. But it may also have a stimulative effect on ISPs–more bandwidth and speed means more revenue. How does this compare to UK/Europe/Asia/Oceania regulation? What do you see as the outcome?
More here: mHealth after net neutrality: Innovation drain or gain? (GovernmentHealthIT); Three Dangers of Losing Net Neutrality That Nobody’s Talking About (Wired), Net Neutrality is Dead! Long Live Net Neutrality! (Wall Street Journal) And an advocate of Congress getting involved (!) is Greg Slabodkin in FierceMobileHealthcare. Hat tip to Editor Charles Lowe for pointing out the potential effect on mHealth.
The ‘FDA Office of mHealth‘ bill (H.R. 6626) as sponsored by Mike Honda, Silicon Valley’s House Representative (California 17th District), which expired with last year’s Congress [TTA 18 Dec] will be revived with revisions, according to MedCityNews. (Rep. Honda will be keynoting on the second day of MedCityNews’ ENGAGE conference in Washington D.C. in June.) Formerly dubbed HIMTA (Healthcare Innovation and Marketplace Technologies Act) will now include how that office will work with the alphabet soup of other agencies: FCC, HHS, ONC, FTC. It struck this Editor in December–and later [TTA 28 Mar]–that this bill does not go far enough. In its good intentions to speed mHealth approvals by creating a framework plus monetary incentives, it is not powerful or independent enough to slice through or bypass various turfs. What would be revolutionary is simplification. Why not an independent unit that draws from FDA, FCC and HHS, but has priority and license to cut through red tape? But that would require major giving up of ground–and with this Federal Government, that ain’t gonna happen. Add to it that the most innovative work–and usage– is being done at DOD (DARPA, T2) and the VA, and the alphabet soup becomes goulash. Wall Street Journal’s Venture Capital Dispatch
With no official announcement, the US Federal Communications Commission (FCC) has selected Matthew Quinn from the National Institute of Standards and Technology (NIST) for its first-ever Director of Health Care Initiatives, as reported in FierceMobileHealthcare (via Mobihealthnews). His maiden appearance was at a recent Care Continuum Alliance Capitol Caucus in Washington, D.C. This contrasts with the relative fanfare back in December of the new position and its big scope–administering the Health Care Connect Fund, the health care part of the National Broadband Plan, developing spectrum policy for Medical Body Area Networks (MBANs) and other medical devices as well as expanding broadband to skilled nursing facilities (SNFs). It’s all quite curious as it seems to be a muting of the FCC’s previous aggressive stance in cutting its slice of the pie in health care. FierceMobile’s editor Greg Slabodkin wonders what door the new Director will be using in Welcome, Mr. Quinn, I don’t believe we’ve been introduced.
For those looking for alternatives to FDA approval of mobile health or medical apps, some organizations have been tossed into the Suggestion Box. It’s a veritable alphabet soup of abbreviations, starting with ONC (Office of the National Coordinator for Health Information Technology). There’s the private sector review entity initially created for EHR certification with the formation of CCHIT (Certification Commission for Healthcare Information Technology, part of HHS) or what CCHIT has now become, a private/federally monitored model. There’s also the FTC (Federal Trade Commission) which pulled an acne treatment app of the market, and the ever-popular FCC (Federal Communications Commission) which has been searching for a Director of Health Care Initiatives and after all has millions to dole out in the Health Care Connect Fund. Neil Versel’s latest over at Mobihealthnews focuses in on this (omitting the FCC), considers the suggestion by Thomas Santo, MD in a recent column at KevinMD that medical industry associations (AMA–American Medical Association, ACP–American College of Physicians, etc.) should also be involved with health tech tools, to the extent of a rating system or even endorsement–and argues against it. (This excludes Happtique’s certification program standards/performance requirements.) But since both FDA and the FCC are involved, now separately, in most things mHealthy, and at least one proposed bill (HIMTA) would create an FDA Office of Mobile Health, why not have a joint office as a single point of contact? FDA regs would remain the same, but the review would encompass both medical effectiveness and wireless issues.
The long-drawn out drama on the FDA’s endlessly pending (July 2011) final regulations on the approval procedure of mobile health apps seems to be coming to a crescendo with next week’s US House of Representatives Energy and Commerce Committee hearings. There are missed deadlines, unanswered questions, reports due, an apparent repositioning of mobile apps as ‘health IT’, the involvement of an alphabet soup of agencies–Health and Human Services (HHS), the Federal Communications Commission (FCC) and, most importantly the Office of the National Coordinator for Health Information (ONC) under HHS, which seems to be breaking away and asserting control in the FDA vacuum. Cheering on ONC for dominance are health IT companies such as McKesson and perhaps some members of the Committee. This apparent lassitude on FDA’s part is certainly odd, as according to Mobihealthnews, the FDA has already approved 75 mobile medical apps. Brian Dolan over there has done fine work on sorting out this ‘who’s on first?‘–and why–situation in two articles, Republicans, EHR vendors want ONC to take over medical app regulation (14 Mar) and Congress asks FDA if “actual use” is factor in medical app regulation (6 Mar).
Related TTA: The mHealth road map, as drawn by the FCC and Adding another chef to the government regulation kitchen