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COMING INTO COMPLIANCE WITH IDMP

The European Medicines Agency (EMA) is in the process of implementing the standards developed by the International Organization for Standardization (ISO) for the identification of medicinal products (IDMP). These are a set of common global standards for data elements, formats and terminologies for the unique identification of and the exchange of information on medicines. Following a phased implementation process, pharmaceutical companies will be required to submit data on medicines to EMA in accordance with these formats and terminologies:

  1. Preparation phase for controlled vocabularies, initial organisation dictionary and document approach such as ISO technical specifications and EU implementation guide, is scheduled for July 2016.
  2. The transition phase will follow with product & substance pre submission (Q1 2017) and submission (Q2 2018). eMEDICS.org form solution could help pharmaceutical companies in:
    • the preparation of electronic submission of product and substance information – the Marketing authorisation holders will still have to submit in the XEVPRM format during this phase to comply with their regulatory obligations under Article 57 of Regulation 726/2004, and
    • the phased implementation of electronic submission (product iteration 1, substance, product iteration 2) – EMA will convert existing medicinal product and substance entities into the new HL7 format and assist industry in the submission of IDMP products via the new format. Pharmaceutical companies will be required to confirm this conversion performed by EMA, and to enrich the data with additional information. The XEVPRM format will then be decommissioned and the new format will become mandatory to comply with Article 57 data submission requirements. The Agency will provide a detailed plan, including details of what data is to be submitted, and communicate when the new format will become mandatory well in advance of any change.
  3. After Q2 2018, the maintenance phase will start with the implementation of subsequent product iterations and expansion and management of pharmaceutical content.

eMEDICS.org generic form solution allows pharma companies to implement any IDMP submission form and its associated HL7 messages. We support ISO 11238 (regulated information on substances), ISO 11239 (routes of administration, packaging, pharma dose forms…), ISO 116115 (product information, entire product life cycle…), ISO11616 (pharmaceutical product ID – PhPID…) and ISO11240 (unit of measurement…).

For additional information about IDMP, please see below a great white paper from the consulting company HighPoint Solutions.

New regulations for the identification of medicinal products (IDMP) are in the process of being finalized by the European Medicines Agency (EMA), the Food and Drug Administration (FDA), and, in all likelihood, other authorities as well. They will be based on a series of standards that were created by the International Organization for Standardization (ISO) and will go into effect in Europe July 2016. The regulations provide a common framework for identifying medicinal products and should lead to better drug safety.

While IDMP started as a European initiative, its impact actually extends far beyond Europe. As the FDA and other ICH region regulators adopt IDMP, the regulations will affect every pharmaceutical company that manufactures or sells medical products in the respective regions. As such, all pharmaceutical companies intending to market products in ICH regions need to develop an IDMP compliance strategy. Companies found to be noncompliant risk fines or exclusions that are not trivial. European regulators may fine non-compliant companies—even those only selling products in Europe—to the tune of 5% of the products’ annual gross revenues from the European region. Should the company be found to be out of compliance on a recurring basis, that company could be barred—completely—from doing business in Europe until such time as it can prove IDMP compliance. The FDA has not yet published non-compliance penalties, but they are expected to be on par with those imposed by the European authority. Yet there lies the real issue: How do you develop—let alone implement—a compliance strategy when the authorities have not yet agreed upon the final standards? If you prepare a strategy based solely on the ISO Standards and the authorities either decide not to implement all of them (or decide to implement some of them in an unanticipated manner), you may find yourself having put considerable effort moving down a dead-end path. If you wait until the IDMP standards are approved then you may find yourself left with little time to implement your compliance strategy.

Indeed, according to the outcomes of a recent ISO TC 215 meeting in Japan, the European authority driving the IDMP process intends to provide a final draft of the IDMP guidelines only 11 months in advance of the July 2016 compliance date. The “official” guideline will not even be published until five months after the final draft is released, which realistically leaves no option to wait until the official IDMP standard becomes available! Moreover, as of this writing there is no clear provision for a compliance extension or grace period. Regulators in all the regions expect that your company will be IDMP compliant starting in July of 2016.

Understanding the Compliance Requirements

So what does IDMP compliance look like? Fundamentally, IDMP requires that information about your medicinal products be expressible in terms of a set of standard identifiers. The identifiers are not altogether new: they build on an identification hierarchy that you may already have created in the course of building a EudraVigilance Medicinal Product Dictionary (in its original form [EVMPD] or in its extended form [xEVMPD]). They likely will also have overlap with information filed within Structured Product Labeling (SPL) filings used in the U.S. and other product registries globally.

However, IDMP is a quantum leap beyond EVMPD, xEVMPD, and SPL. There are new identifiers, new categories, and new ways to express the relationships between the elements in the data model. While it may have seemed possible (not advisable, but possible) to maintain the data for an EVMPD or even an xEVMPD via spreadsheets, that’s simply not going to be possible with IDMP. IDMP should be integrated into the DNA of the enterprise itself. It needs to drive the construction of data models throughout your enterprise. Your IT infrastructure can then recognize it, even across multiple systems, processes, and organization divisions. So will your R&D, testing, documentation, and manufacturing processes.

Reframing the Requirements

For a pharmaceutical company, the question surrounding the matter of IDMP compliance is fundamentally a strategic one: how you integrate these identifiers into your enterprise to achieve compliance? There are really only four paths open to you. You could redefine all your existing products, processes, and procedures in terms of the new IDMP data models and schemas. For any but the smallest startup this is likely to be an extreme response—in terms of cost, effort, and virtually any other metric you might consider.

A second possible approach to IDMP could be the “Integral Approach,” in which a Regulatory Information Management (RIMS) solution holds all the data required to create and manage IDMP submissions. But since most pharmaceutical companies already have established systems for regulatory affairs, supply chain, packaging, and the management of product documentation (national and global labeling, submissions), IDMP data would have to be entered multiple times, which not only creates redundancies but also exacerbates the risk of introducing data errors and inconsistencies. Thus, like the first path described above, the “integral approach” is likely to be an option for smaller companies that that are starting with a “green-field” IT infrastructure.

A third path to compliance involves creating a data warehouse that could systematically extract and transform
information about medicinal products whenever an IDMP-compliant view of medicinal products is required.
Proponents of this approach suggest that it might avoid having to retrofit existing information into a new data
model while still enabling you to provide IDMP-compliant reports that regulators might require at any point.
We at HighPoint consider the data warehouse approach unadvisable—for several reasons:
– A data warehouse is typically built to reconcile disparate data sources with reporting outcomes in mind, but IDMP is more about understanding and managing the relationships between data entities. As such, solving for IDMP is more of an upstream challenge, one that requires tools for managing data relationships and the data model itself.
– We don’t know how IDMP regulations may evolve over the coming decade, but we can confidently predict that evolving a data warehouse implementation to accommodate changes in IDMP regulations will be a costly and complicated endeavor.
– The extract/transform processes associated with a data warehouse project assume the integrity and quality of the source data itself—and assume that all the data that might be required for IDMP compliance is already present in the existing data stores. These assumptions may not be valid, and a data warehouse is not designed to address quality and completeness issues. IDMP should be integrated into the DNA of the enterprise itself. It needs to drive the construction of data models throughout your enterprise.

Ultimately, a data warehouse may be part of an overall information management solution, but by itself it will likely be an insufficient solution for IDMP. Instead of looking at IDMP compliance as a pharmacovigilance reporting challenge, it’s worth stepping back and taking a second look: IDMP is really a challenge around visibility and insight into the essential elements that inform your business. Most organizations and processes have grown—either organically or through acquisition—in ways that occlude the insight that IDMP demands. You may still have data silos that limit visibility, different ways of describing doses or units of measurement among product lines, and/or a variety of substance naming conventions that vary from product to product. IDMP is really all about enabling a single, consistent view of all medicinal products— aggregated across all regions, processes, and business functions.

Viewed this way, we at HighPoint firmly believe that IDMP should be seen less as compliance challenge and more as an operational opportunity. Any company that wants to operate more efficiently, effectively, and nimbly in a rapidly changing world would do well to have a central, standard way of understanding their product data across (and outside of) the enterprise. This view presents a fourth path to IDMP compliance.

A Master Data Approach to IDMP Compliance

From HighPoint’s perspective, the underlying challenge of IDMP is fundamentally a master data challenge. Thus, the fourth channel to compliance is to leverage a master data-driven methodology to solve for IDMP. Your organization must discover how and where key data elements relating to IDMP exist within the organization, cleanse and transform certain data elements for consistency (as required), and then harmonize those data elements and definitions across the enterprise. Thus, the name of each substance becomes consistent across the enterprise, as do units of measure, the names of vendors and suppliers, and so much more. In turn, with a master data-driven approach you can effectively refine your underlying data schemes and relationship models as necessary to map to the IDMP standards. You will even be positioned to discover where certain data elements may be missing from the data scheme you are using—and with that insight you can determine a best course of action to account for that data element in any reporting that may later be required.

By approaching IDMP compliance as a master data challenge you can avoid many of the drawbacks associated with the aforementioned data warehouse approach while still achieving the goal of regulatory compliance. When it comes time to prepare compliance reports in response to a request from the authorities, you will be reporting on the actual master data—not an extract of that raw data that must first be transformed and refined on the fly to provide the information a regulator requires. Having performed the analysis requisite to undertaking a master data project, you will be able to report on that data with a much higher level of confidence than you would when reporting on extracts of data from a data warehouse. Along the way, you will gain something else, too: by solving for IDMP with a master data-driven methodology, you will gain that single, trusted view of your product data—across product lines, across facilities, across geographies, and more. Such insight positions you to make better strategic and operational decisions because you’ll have a greater understanding of the impact of small decisions on the whole of your operations. You’ll be able to respond to change—whether imposed from without or elected from within—with greater agility, greater speed, and a greater understanding of the ramification of the changes you make.

Indeed, approaching IDMP compliance as a master data project enables you to deliver benefits far beyond the ability to report accurately to health authorities. Some of the benefits that accrue to different parts of your organization include:
– Regulatory can easily determine the currency and geography of marketing authorizations.
– Manufacturing can easily and accurately compare production across sites (internal and external). This includes single- version-of-the-truth insights into quality, production costs, and overall equipment effectiveness (OEE).

  • With clean, consistent, well managed master data, manufacturing also gains insight into raw material and work in progress inventory for improved planning. Supply chain managers gain global inventory visibility and an improved ability to plan. Procurement gains a consistent and complete view of spend across the entire enterprise, which improves the organization’s ability to negotiate and take advantage of volume-based discounts.
  • Finance gains accurate insight into inventory and stores, which can result in lower requirements for working capital and improve cash flow.
  • Customer/Patient Services gains complete information on products, increasing patient/prescriber confidence and reducing call center time per call – R&D gains better and faster visibility into molecule performance in the market, beyond clinical trials.

For many large pharmaceutical companies, the need to manage organizational data more effectively has been known for some time, and the compliance requirements of IDMP provide just the excuse to implement a master data solution.

For many smaller pharmaceutical companies, though, the problem of inconsistent master data and the management complexities arising from data silos and disparate data structures are not as immediate. Smaller companies, even many mid-sized companies, may not feel those pains as acutely. No matter: you still need to achieve IDMP compliance. If you approach this effort from a master data perspective then you will set a foundation in place that will help you continue to avoid problems as you grow. Your efforts to manage your master data today should be viewed as proactive efforts to avoid master data problems tomorrow—because without a strategy and a solution for managing master data in the future you will find yourself struggling in future years. It really isn’t a question of whether; it is simply a question of when. Acting now, before the problem is acute, can help you avoid that problem later on.

HighPoint and the IDMP Challenge

HighPoint Solutions is singularly positioned to help pharmaceutical companies meet the challenges posed by IDMP. The final regulations remain subject to approval by the authorities, but we recommend that organizations plan ahead by developing and executing a strategy for compliance. While this might seem unwise, given the possibility that health agencies might not use (or might use differently) some of the ISO IDMP regulations, the approach to execution that we recommend makes it quite easy to adjust your efforts at a later date in compliance with any changes that may occur. That flexibility arises in part from the master data- driven approach to which we have already alluded. Implementing a master data solution requires you to develop a comprehensive understanding of all the data structures within the enterprise—and there’s no reason to delay the commencement of that task. The health authorities may have approved the standards by the time your data structure inventory is complete, which will make it easier to determine how the data you already have will need to be transformed or normalized. Yet even if your inventory is complete before the rules are finalized, the project tasks involved with planning the transformation can continue—at least up to the point at which the data must be imported, cleansed, and transformed.

As noted previously, IDMP builds upon EVMPD. HighPoint has a prebuilt EVMPD solution that positions the organization to move to IDMP. As soon as the authority provides their final guidance on the IDMP standards, an organization that has already mastered its data into the schema outlined by the HighPoint EVMPD solution is well-positioned to evolve their data models into the schema approved by the authority (and achieve greater control of master data at the same time). Some pharmaceutical companies will already have master data solutions for product data. The challenge facing these companies becomes one of evolving an existing deployment to meet the needs of IDMP. Companies in this position may be much closer to compliance than they know. More than anything, most companies with existing solutions will simply need guidance on how to evolve their solutions to accommodate the specifics of the data models and schema associated with the IDMP regulations.

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congress interoperability

Interoperability – Docs send Congress meaningful SOS

HealthCare IT News, Interoperability in Healthcare, November 6, 2015

The rallying cry about interoperability to do something about the meaningful use program is getting louder and more insistent.

Earlier this week, the American Medical Association and 111 medical societies sent please to Congress urging a reprieve – or at the very least, a “refocus” of Stage 3 of the program, they write.

“We are writing to express our strong concerns with the decision by the Administration to move ahead with implementation of Stage 3 of the Meaningful Use program despite the widespread failure of Stage 2,” they state in their Nov. 2 letter to Majority Leader Mitch McConnell and Minority Leader Harry Reid.

Interoperability should be front and center now, they say.

“We believe that the success of the program hinges on a laser-like focus on promoting interoperability and allowing innovation to flourish as vendors respond to the demands of physicians and hospitals rather than the current system where vendors must meet the ill-informed check-the-box requirements of the current program,” leaders of the medical organizations write.

They claim the Administration has not responded to this need and instead has chosen to perpetuate the current failed program through the release of Stage 3 Meaningful Use.

“It is unrealistic to expect that doing the same thing over and over again will result in a different outcome,” they write. “We believe, therefore, that it is time for Congress to act to refocus the Meaningful Use program on the goal of achieving a truly interoperable system of electronic health records that will support, rather than hinder, the delivery of high quality care.”

In their letter to House Majority Leader Paul Ryan and Minority Leader Nancy Pelosi, they write: “Congressional action to refocus this program is urgently needed before physicians, frustrated by the near impossibility of compliance with meaningless and ill-informed bureaucratic requirements, abandon the program.”

In a move that surprised many healthcare providers – both in hospitals and in physician practices – CMS released the final rules for both Stage 2 and Stage 3 in one fell swoop October 6.

In the months leading up to the reveal of the final rules, many stakeholders continued to hope for a delay of Stage 3 requirements.

By the time 600 or so CIOs met for CHIME’s Annual Fall Forum in Orlando in mid October, the rules were out – and CIOs Pamela McNutt and Liz Johnson were prepared to analyze and advise.

They were specific about their Stage 3 concerns:

  • Requires 365-day reporting
  • Increased thresholds on troublesome measures
    – Patient Engagement Threshold – 10%, includes use of APIs
    – Requires inclusion of patient-generated data or from non-clinical settings
    – Transitions of Care Threshold increased
    – Establishes six public health reporting measures, requires bi-directional exchange with immunization registries
  • Actions to meet measures must be electronic – paper-based methods will not suffice (e.g. summary of care and patient education)
  • 2015 Edition of CEHRT required for Stage 3 reporting
  • Vendor and Provider readiness
  • CQM’s can be reported by attestation through 2017, electronic submission required starting in 2018

There still remains an opportunity to comment on the rules through December 15.

“It is your right and duty to comment,” Johnson told a packed room one of CHIME forum’s sunrise sessions in Orlando.

*American Medical Association (AMA)
Centers for Medicare & Medicaid Services (CMS)
College of Healthcare Information Management Executives (CHIME)

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smatphone hipaa

HIPAA privacy and Mobile app. Check with OCR

HealthNews – ‘Building HIPAA privacy and security protections into technology products enhances their value’

Many mobile health developers — and rightfully so! — are curious about just what features and protections their devices need to have in order to comply with HIPAA privacy rules.

The U.S. Department of Health & Human Services’ Office for Civil Rights launched a website this week where mobile developers can get up to speed with the critical security issues at stake.

“We are experiencing an explosion of technology using data about the health of individuals in innovative ways to improve health outcomes,” write OCR officials. “Building privacy and security protections into technology products enhances their value by providing some assurance to users that the information is safe and secure and will be used and disclosed only as approved or expected.”

Even though state and federal laws – such as the HIPAA Privacy, Security and Breach Notification Rules – have specific prescriptions for IT privacy protections, many developers remain in the dark about just how those regulations are germane to their technology, according to OCR.

Anyone is welcome to browse the site: “Users who want to submit questions, offer comments on other submissions or vote on how relevant the topic is will sign in using their email address, but their identities and addresses will be anonymous to OCR,” officials write. “OCR will consider the input provided on this site in developing our guidance and technical assistance efforts.”

The aim is a two-way flow of information, also helping OCR get a better handle on what HIPAA guidance is most helpful: “What current provisions leave you scratching your heads? How should this guidance look in order to make it more understandable, more accessible? Stakeholders can also use this page to submit questions about HIPAA, present a use case, or see what their peers are discussing. Users can comment on the discussions and vote on which topics or use cases would be the most helpful or important.”

Posting or commenting on the site “will not subject anyone to enforcement action,” officials are careful to note.

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Office 2016 – 3 data privacy features

Microsoft Office 2016 and Windows 10 coming on the heels. The new productivity and collaboration suite brings security features specifically for healthcare entities

Those were mostly lost amid most of the trade press and mainstream media coverage, which largely focused on the new collaboration functionalities. That makes sense given the new Office’s overarching themes as collaboration, productivity, and security.

While there are collaboration and productivity enhancements for health entities, healthcare CIOs and CISOs might be most interested in the privacy features.

Here are three of those:

1. PHI recognition: Outlook can now recognize protected health information in an attachment and warn the user before sending to avoid the common mishap of PHI landing in the inbox of someone who should not receive it. And different permissions can be set to stop some users from even sending PHI at all.

2. Smart Attachments: This feature gives users the option of sending a link in lieu of heavy documents that consume a lot of memory. The reason that matters: When clinicians send a link via OneDrive for Business, the security mechanism authenticates the user and Exchange can track whether a recipient even clicked on that link – which could help account for what happens should data be sent to unintended recipients.

3. Encryption, single sign-on and authentication: This is kind of a threefer, admittedly. They are connected enough to group together. In addition to Office, Microsoft injected encryption into Office 365 services, so now both documents and emails are encrypted, while Windows Hello serves as a single sign-on capability and Windows Passport is now being used by third-party apps, such as Allscripts EMR, for facial recognition.

Office 2016 comes on the heels of Windows 10, which also brought new features specifically for healthcare.

Those include the ability to “snap together” different applications so clinicians can view an EMR alongside, say, a home health app, business intelligence tools for visualizing care data, mapping techniques for population health, as well as care management and information sharing functions

Windows 10, Office 2016 and the forthcoming Windows 10 Mobile are the foundation of the company’s “One Windows” strategy — to enable healthcare organizations to sync apps and data across smartphones, PCs, tablets and a wide range of medical and IoT devices.

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Forbes – A Startup Poised To Disrupt In-Home Senior Care

The stark reality is that we will all grow old at some point.

The years have a way of catching up with us–and when they do, we generally have one common wish: to live out our years in our existing homes in a safe and comfortable manner.

But finding a qualified caregiver for our loved ones, if we are unable to care for them, may be the most difficult part of realizing that wish.

The statistics are daunting when it comes to home care for older persons. There are some 55 million adults taking care of their parents, with over 2 million caregivers.

And close to 92% of adults when surveyed would rather live in their own home as opposed to a nursing home. The fact is that in a large percentage of cases, family members have difficulty caring for a senior relative, so searching for a caregiver is a necessity.

While there are tens of thousands of agencies across the country that can match you with a caregiver, there is no customization of the process, and you have no way of seeing what’s going on when you are not home.
unnamed

Programming since the age of 12, the computer engineer-turned-entrepreneur migrated to Silicon Valley working at Yahoo YHOO +0.00%, then transitioned to Bain Ventures.

After he and his family struggled to find a caregiver for his 93-year old grandfather who was previously living independently, Bruno decided to quit his job at Bain Ventures to start a company that would make it easier for families to locate and hire qualified caregivers.

“If you asked me four years ago what I would be doing now, there was no way I would have guessed that I would be working in aging—but these things all happen through personal experience,” said Bruno.

Bruno did some research, and after contacting and volunteering at several dozen homecare agencies, he realized what a huge need — and opportunity — exists in the $80 billion in-home senior care market, which today has a poorly organized workforce and a customer base often with chronic medical illnesses who may not receive the best possible care.

Bruno’s personal journey to find the best possible care for his grandfather uncovered myriad issues ranging from lack of coordinated training for caregivers to a feeling of emotional detachment that emanated in the quality and approach to geriatric care, he explained.

Without the proper tools for the families, and without the support from the caregivers themselves, there had to be another answer to providing high quality home care for seniors.

Bruno kept asking himself why the homecare industry was in such disarray, and by volunteering at several agencies, he became convinced that there was a more efficient way to improve delivery by using technology to power the change.

“We have focused on building a technology platform that supports caregivers and empowers them to do the best job possible, at the same time creating transparency for families so they can see what’s happening real-time in the home,” explains Bruno. “It also creates a very reliable service which demonstrates that we will do the work that requires older adults to be happy.”

Bruno’s core philosophy and company’s mission is simple: “Every older adult deserves a beautiful day.”

So, Bruno assembled a team of other like-minded 20-somethings, including Harry Heymann, who designed the architecture and wrote the backend code for Four Square, considered a pioneer of consumer mobile applications.

Hometeam, launched in 2013, is based in New York City, but also has clients in New Jersey and Philadelphia. The company plans to expand into nine more states within the next year. The company raised $11 million last year from Lux Capital, IA Ventures and Recruit Strategic Partners.

The company has already sent more than 250 caregivers into hundreds of homes throughout New York, New Jersey, and Pennsylvania.

The caregivers are made to feel part of a team, and are given employee status with health insurance and workers comp benefits, as opposed to being independent contractors or considered part-time workers. They are also compensated 30-50% more than a typical caregiver hired by a standard agency in current markets. While typical wages for a standard caregiver hover around $9-$10 per hour, Hometeam’s wages are closer to $15 per hour. Clients are charged from $20-$27 per hour.

The company’s mission is to transform the in-home care and aging experience by providing elderly clients with personalized care planning, expert caregiver matching, custom mobile technology, and proactive case management to improve older adults’ health and well-being while giving their families peace of mind.

Using technology to improve in-home care has other competitors currently in the marketplace. Among the notables, Honor, founded by Seth Sternberg, formerly of Google GOOGL -0.77%, launched earlier this year in the San Francisco Bay Area, and had raised 20 million by April of 2015. Touting itself as a technological solution to in-home care, its impressive line-up of supporters include Marc Andreessen, as well as Jeremy Stoppleman, CEO of Yelp. Its caregivers are not employees, but independent contractors.

CareZapp, a UK start-up in 2014, prides itself on its technological wizardry leading to more holistic care, allowing patients to communicate with other patients as well as doctors and family members. The app can also interface with other smart in-home technologies including motion sensors that can track movements and alert family members when there are aberrations.

 

The Hometeam Solution

Hometeam sets itself apart from its competitors by developing its own software that intelligently matches families with experienced caregivers, connects families to their loved ones through the use of mobile technology in the home, and helps caregivers plan days that improve the quality of life of older adults.

Hometeam also distinguishes itself is by having its caregivers identify activities which every patient prefers–something that can be challenging when a person has physical limitations which impair movement and mobility.
Hometeam iPad mood-3

The core foundation of technology for Hometown begins with an iPad for each home that is used by the caregiver to send texts, pictures, and update family members about any changes in medical conditions.

“I want older adults to live more comfortably and happily in their own homes,” said Bruno. “I want to imagine what a perfect day looks like for each of our clients and make it come alive with a combination of great mobile technology and the best caregiving team possible.”

The broader picture, however, may become the integration of technology-enabled apps that also can monitor key parameters of health such as blood pressure, heart rate, medication compliance, and ideally dispatch and communicate with a medical provider when there are aberrations in patterns of vital signs.

“America will face a tremendous challenge in caring for our senior citizens,” said Rich Able, Founder of X2 Biosystems and Partner, Stratos Group Seattle. ”It will be imperative to implement ‘The Connected Senior Citizen’.”

Family members, clinicians, and assisted care providers will need a new generation of technology platforms to help them stay informed, coordinated, and most importantly, connected,” added Able.

“Aging in place and staying in one’s own home environment is highly desirable to most senior citizens,” emphasizes Able, so in order to accomplish this goal, equipping the home with the most useful technology will become critical in the next few decades.

“Startups in the ‘Connected Senior’ vertical must develop meaningful biometric wearables that provide familty members, caregivers, and clinicians the information necessary to attenuate the need for costly emergency care, hospital stays, and multiple physician visits,” he added.

Bruno explains that his company is actively seeking partners to accomplish these higher level functions to advance the concept of such a “connected senior home.”

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icon form health care hospital

Patient Home Care Monitoring Will Revolutionize the Health sector in 2016

Real-time health care monitoring including the patient’s home continues to gain importance as pressures come from a variety of sources to reduce risks and costs of readmissions and hospitalizations.

The Centers for the Medicare and Medicaid Services (CMS), enforcing the 2012 Medicare Readmission Reduction Program, the States and managed organizations have to deal with tighter budgets, rising costs of service, and stricter capitation rates.

Until recently, homecare reporting was archaic at best. The home was a “black box” where no information was generated when a home aide entered the residence and closed the door. Well-intentioned aides and nurses visited a patient’s home, administered and documented their visit in piles of paperwork that were often not reviewed or actionable.

Data input was first “modernized” to record home aide hours and minimal data about care by telephone. Such systems are used primarily for time and attendance. Aides visit the patient’s homes and use the patient’s home phone to document that their work shift has started. When the shift ends (and only when the shift is over), the home aide dials the phone to report the end of their shift, and with all the limitations inherent in pressing numbers on a dial pad, report that they had administered a few elements of care. Since they cannot see the output of what they entered, such data entry is error prone and of limited value.

To move home health care forward and to reduce costs requires a new approach. Forward thinking home aide agencies, health care providers, managed care organizations and hospitals are looking for innovative solutions that leverage the proliferation of tablets, smartphones and the ubiquitous Cloud to improve care at home, where patients spend most of their lives and where so many significant health events occur.

Thanks to technology, the “black box” of healthcare monitoring can be transformed into a sea of data where home health aides can gather 500-1,000 data points per month. The real-time collection and utilization of data from the home will offer these ten key benefits for specific patient populations, their families and every member of the patient’s care team in 2016.

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Reality check-up for health care in Canada

Reality check-up for health care in Canada

Canada’s health care system has had an unhealthy cough for years and it’s not getting better on its own.

According to the Fraser Institute the median wait time for treatment after seeing a doctor is now 18.2 weeks. So, on Jan. 1, your doctor tells you that discomfort on your backside might be a disorder that causes you to grow a tail. He refers you to a specialist who confirms the diagnosis. Alarming news for sure.

You could try to manage your condition but you’ve noticed that your golden retriever is forever coming home with twigs and brambles in his tail, which would be embarrassing in an office setting. So, you opt for the surgery. Then your specialist delivers the bombshell. You can’t get in until May.

You briefly consider going to a veterinarian before accepting that you have to live with the pain and embarrassment. You will need to get your pants altered.

Now, please understand that the situation I have described is not based on an actual case. I use it only to illustrate the seriousness of the situation in Canada. In 1993 the same process would have taken 9.3 weeks, or about half as long as it does today. Doctors tells us the median time between seeing a specialist and getting treatment is three weeks longer than is “clinically reasonable.” This is health care in Canada.

Note too that spending on health care is rising. Depending on the province it may now consume as much as half of all provincial spending. The polls tell us that timely access to health care is always the public’s first or second priority. And yet after 20 years, many great speeches and campaign promises and trillions of dollars in government spending, the time it takes to access treatment has essentially doubled.

Let’s get specific and look at one medical condition and one province. Consider lung cancer treatment in Alberta.

On Dec. 15, 2011, Alberta Health Services announced “the Expedited Management of Lung Cancer Program aims to ensure that, by March 2013, 75% of patients will wait no longer than 30 days from the time of referral from their primary care physician to when a treatment decision is made, and 60 days from the time of referral from their primary care physician to surgery.” They proclaimed it a “top priority” and allocated $15 million to make it happen.

But on March 27, 2014, the Canadian Institute for Health Information announced that the average wait time in Alberta between a specialist booking a date and the actual surgery was 85 days vs. 49 days, the national average. An epic fail.

I am not picking on Alberta. If the average wait times in Canada have doubled over the last 20 years then Alberta is clearly not alone. Canada’s health care system does not provide timely care and it’s not financially sustainable. Baby boomers are retiring in huge numbers. We are losing them as big taxpayers and gaining them as big patients.

There are a range of possible solutions. We shouldn’t shrink from discussing them just because they challenge old beliefs, many of which are crumbling under the weight of reality.

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October 10, 2015 / Posted by / Reality check-up for health care in Canada