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Bosch’s Telemedicine Shutdown Suggests New Models Are Needed

Posted on June 25, 2015 I Written By

Anne Zieger is veteran healthcare editor and analyst with 25 years of industry experience. Zieger formerly served as editor-in-chief of FierceHealthcare.com and her commentaries have appeared in dozens of international business publications, including Forbes, Business Week and Information Week. She has also contributed content to hundreds of healthcare and health IT organizations, including several Fortune 500 companies. She can be reached at @ziegerhealth or www.ziegerhealthcare.com.

While many new telehealth plays are rapidly gaining ground, the previous generation may be outliving its usefulness. That may be the message one can take from one giant German conglomerate’s decision to shut down its U.S. telemedicine division.

Robert Bosch GmbH recently announced that it would shut down its U.S. telehealth unit, Robert Bosch Healthcare Systems, which makes business-to-business telemedicine systems. Its offerings include patient interfaces, software and platforms.

You may never have heard of this healthcare company, nor of its massive corporate parent Robert Bosch GmbH, but it’s part of a very large conglomerate with virtually infinite resources.

As it turns out, Bosch is a massive firm which competes with market leaders like GE and Siemens. Robert Bosch GmbH, which has existed since 1886, has more than 350 subsidiaries across about 60 countries and employs about 306,000 people. (I could share more, but I’m sure you get the idea.)

While the failure of one company’s telemedicine strategy doesn’t necessarily mean death for all similar plays, it does suggest that the nimble smaller firms may have more of an advantage than it appears.

Bosch Healthcare was actually way ahead of the market with its offerings, which included remote monitoring tools such as a touch-screen device for home use after hospital discharge and a family of mHealth tools aimed at chronic care management.But they appear to have been held back by proprietary technologies in a market that demands cheap and easy.

Ultimately, the end came when the parent company wasn’t happy with how the telehealth division was performing financially, and decided to cut and run. A statement from the company said that Bosch plans to shift its medical focus to sensor technologies to support improved diagnostics.

It’s hardly surprising that a company Bosch’s size would fail to keep up with the marketplace, given its size. No matter how smart the division’s 125 employees were, they were probably saddled with big company politics which prevented them from making big changes. Not to mention low priced tablets appeared and created a low cost competitor.

The question is, will other large players follow Bosch’s lead? It will be worth noting whether other large companies cede the telehealth market to small and emerging entrants as well. It’s not a no-brainer that this will happen; after all, there’s billions to be made here. But they may actually be wise enough to know when they’re ill-equipped to proceed.

I’ll be particularly interested to see what strategies existing health IT players adopt toward telehealth. It’s unclear how they’ll react to rising consumer and professional interest in telehealth technology, but whatever they do it will probably be worth analyzing.

That being said, with smaller companies out there breaking new ground with next-gen telemedicine apps and tools, they’re probably going to be in the unusual position of playing catch up. And in this case, slow and steady may not win the race.

FDA-Approved Digital Health Should Save $100B+ Over Next Four Years

Posted on June 8, 2015 I Written By

Anne Zieger is veteran healthcare editor and analyst with 25 years of industry experience. Zieger formerly served as editor-in-chief of FierceHealthcare.com and her commentaries have appeared in dozens of international business publications, including Forbes, Business Week and Information Week. She has also contributed content to hundreds of healthcare and health IT organizations, including several Fortune 500 companies. She can be reached at @ziegerhealth or www.ziegerhealthcare.com.

Here’s some research which suggests that a lack of “medical grade” digital health tools is perhaps the final obstacle holding healthcare back adopting them full scale — and reaping the benefits.

Accenture released a study last week concluding that FDA-regulated digital health solutions should save the U.S. healthcare system more than $100 billion between now and the next four years.

The scant number of digital health solutions the FDA has already approved has already had a meaningful impact, generating $6 billion in cost savings last year courtesy of improved med adherence, fewer ED visits and digitally-supported behavior changes, Accenture reports.

But that’s just a drop in the bucket, if Accenture is right. The consulting firm expects our health system to save $10 billion this year thanks to use of such devices. And then, as the FDA approves more digital health technology, the savings figure should make dramatic jumps over the next few years, hitting $18 billion in ’16, $30 billion in ’17 and $50 billion in ’18.

What’s intriguing about these numbers is that they assume each FDA approval will seemingly generate not only more savings, but also a cumulative “whole is greater than the sum of its parts” effect.

After all, in raw numbers, the number of devices Accenture is relying on to achieve this effect is small, from 33 approved last year to 100 by the end of 2018. In other words, 67 devices will help to generate an additional $44 billion in savings.

That being said, what makes Accenture so sure that the ever-so-slow FDA will approve even 70-odd devices over the next few years?

* Provider demand:  At present, about one-quarter of U.S. doctors “routinely” use tele-monitoring devices for chronic disease management, researchers found. As hospitals and medical practices look to integrate such solutions with their core EMR infrastructure, they’ll look to please providers who want digital health tech they can trust.

Reimbursement shifts:  Accenture argues that as value-based reimbursement becomes more the norm, health leaders will increasingly see digital health solutions as a means of meeting their goals. And medical device providers will be only to happy to provide them.

Regulatory conditions: With FDA guidelines in place specifying when wellness tools like heart rate monitors become health devices, it will be easier for the FDA to speed up the process of digital health technologies, Accenture predicts. This should support 30% annual growth of such solutions through 2018, the study found.

Consumer health tracking:  Consumer demand for health tracking devices, especially wearables, should continue its rapid expansion, with the number of consumers owning a wearable fitness device to double from 22% this year to 43% by 2020, according to the consulting firm.

While Accenture doesn’t address the impact of digital health tech that doesn’t get FDA approval, there’s little doubt that it too will have a significant impact on both health outcomes and cost savings. Ultimately, though, it could be that it will take an FDA seal of approval to get widespread adoption of such technologies.

Hospitals Test New Early-Warning Systems

Posted on June 3, 2015 I Written By

Anne Zieger is veteran healthcare editor and analyst with 25 years of industry experience. Zieger formerly served as editor-in-chief of FierceHealthcare.com and her commentaries have appeared in dozens of international business publications, including Forbes, Business Week and Information Week. She has also contributed content to hundreds of healthcare and health IT organizations, including several Fortune 500 companies. She can be reached at @ziegerhealth or www.ziegerhealthcare.com.

The following story offers some tidbits on how new technologies, some EMR-based and some offering independent forms of patient monitoring, are popping up in hospitals.  I found the technologies profiled to be quite interesting and I think you will too.

According to a new piece in The Wall Street Journal, U.S. hospitals have begun to test wireless monitoring systems to track the condition of potentially unstable patients, such post-surgical patients or those on narcotic meds that can suppress breathing. The new technology is most popular on med/surg units where patients aren’t generally monitored 24/7 for changes that can prove fatal.

One approach hospitals are adapting is a wireless monitor which is placed under a mattress and tracks patients’ breathing and heart rate. The monitors, which were developed by an Israeli firm called EarlySense, also lets nurses know when patients get out of bed and when to turn them to avoid bed sores. According to the WSJ, EarlySense costs between $80,000 to $200,000 for a 30-bed unit; prices vary depending on how big the hospital is and how many features the product includes.

Academic research is already suggesting that such monitors can make a significant impact on patient care in hospitals. One study appearing in the American Journal of Medicine last year found that use of the wireless monitors was correlated with both shorter stays and a lower rate of code blue events as compared to units that didn’t use the monitors.

Another technology, software known as the Rothman Index, cross-references 26 variables in medical records and uses them to score a patient on a scale from 1 to 100, with lower scores suggesting that the patient needs to be watched more closely or receive immediate help. The software, which costs roughly $150,000 for a 300-bed hospital, places updated scores regularly on a graph. Some 70 hospitals already have the software in use.

The University of Pittsburgh Medical Center children’s hospital will soon join that number, rolling out a pediatric version of the Rothman Index software in June. UPMC, which has always invested heavily and inventively in new HIT approaches, chose to implement the new software after a research study appearing in Pediatric Critical Care Medicine found that it could effectively supplement staffs’ effort to track kids.

Yet another technology, used at Brigham and Women’s Hospital in Boston, rates patients’ risk of developing serious problems in real time, by analyzing patterns found in lab results, vital signs and nurses’ assessments gathered from EMRs.

Regardless of how you slice it, it’s clear that hospitals are poised to make big leaps in how they monitor patients on the verge of destabilization. This looks like a very promising set of approaches.

Infographic: How Mobile Health Use Is Changing

Posted on May 26, 2015 I Written By

Anne Zieger is veteran healthcare editor and analyst with 25 years of industry experience. Zieger formerly served as editor-in-chief of FierceHealthcare.com and her commentaries have appeared in dozens of international business publications, including Forbes, Business Week and Information Week. She has also contributed content to hundreds of healthcare and health IT organizations, including several Fortune 500 companies. She can be reached at @ziegerhealth or www.ziegerhealthcare.com.

Mobile health apps and hardware offer intriguing possibilities, though it’s hard for providers to tell what models and methods of use are going to stand out.  Clearly, mHealth is going to change the way care is delivered, and how patients take part in that care, but how?

Here’s a tidbit from McKesson that might offer some useful insight. The infographic, which draws on data from The Economist Intelligence Unit, predicts that mHealth is moving from providing consumer information to driving patients’ involvement in their own care.

One of the more interesting details in this chart is the prediction that within five years, the percentage of people using mHealth apps to share information will fall from an already-low 17% to 14%.

I was also intrigued by the notion that the number of people using mHealth to gain social support will rise from 17% now, rise to 26% then fall to 13%.  Does this suggest that consumers will shift communications styles back to more face-to-face channels of support?  That they’ll rely on some technology or model that hasn’t been invented yet?
It’s something to consider.

 

photo-changing-trends-in-mobile-health-technology

 

5 Medical Device Tips for Maximizing Your IP (Intellectual Property) Portfolio

Posted on March 3, 2015 I Written By

John Lynn is the Founder of the HealthcareScene.com blog network which currently consists of 10 blogs containing over 8000 articles with John having written over 4000 of the articles himself. These EMR and Healthcare IT related articles have been viewed over 16 million times. John also manages Healthcare IT Central and Healthcare IT Today, the leading career Health IT job board and blog. John is co-founder of InfluentialNetworks.com and Physia.com. John is highly involved in social media, and in addition to his blogs can also be found on Twitter: @techguy and @ehrandhit and LinkedIn.

The world of medical devices is really fascinating. It’s a world that I think many hospitals know about and many more hospitals are starting to learn about as they grow some medical device innovations in house. With that in mind, I was really intrigued by a list I was emailed of 5 medical device IP tips from Frank Becking of Panthera MedTech.

  1. Control access to sensitive information: Don’t talk publicly about your idea before pursuing the necessary protection. Even with confidentiality agreements in place, until you have filed for a patent any disclosure risks your potential rights and future prospects.
  2. Make sure your company owns its intellectual property: This might seem obvious but it is easy to overlook key steps, like putting in place and enforcing agreements that ensure that work produced by employees and independent contractors becomes the property of the company. And making sure that those same contractors or employees do not have pre-existing, conflicting obligations to other parties. Work with legal counsel to ensure state law compliance of IP-related agreements, as some states restrict assignment and other scope.
  3. Don’t neglect country-by-country protection: IP protection opportunities differ around the globe. Select state-side IP counsel that has existing relationships with expert foreign counsel who can advise on how best to navigate international waters.
  4. Actively avoid third-party IP entanglement: Too often, corporate executives focus on the patentability of their own IP. Understanding and tracking 3rd party patents and the progress of their pending claims (i.e., handling questions of Freedom to Operate) often has a greater effect on corporate valuation. A startup with technology that infringes upon another company’s IP can be dead in the water. Design-around is very often an option, but usually represents a costly and time-consuming exercise that should be guided by experienced IP counsel.
  5. Formulate an IP enforcement strategy: It is important to monitor the market to ensure that your IP rights are not being infringed. However, the bigger question is often what a company should be done if it detects infringement. Venture-capital funded startups are notoriously averse to engaging in litigation. Sending a cease-and-desist letter can open the door for the noticed party taking the fight to you. Again, working closely with experienced IP counsel is key to understanding and pursuing your enforcement goals.

How many of your hospitals are dealing with these types of issues?

A Turning Point? Wearables Could Save 1.3M Lives by 2020

Posted on December 22, 2014 I Written By

Anne Zieger is veteran healthcare editor and analyst with 25 years of industry experience. Zieger formerly served as editor-in-chief of FierceHealthcare.com and her commentaries have appeared in dozens of international business publications, including Forbes, Business Week and Information Week. She has also contributed content to hundreds of healthcare and health IT organizations, including several Fortune 500 companies. She can be reached at @ziegerhealth or www.ziegerhealthcare.com.

For years, wearable health bands have been expensive toys useful almost exclusively to fit people who wanted to get fitter. On their own, wearables may be chic, sophisticated and even produce medically relevant information for the user, but they haven’t been integrated into practical care strategies for other populations.

And with good reason. For one thing, doctors don’t need to know whether an otherwise-healthy patient took 10,000 steps during a run, what their heart rate was on Thursdays in June or even what their pulse ox reading was if they’re not wheezy asthmatics. Just as importantly, today’s EMRs don’t allow for importing and analyzing this data even if it is important for that particular patient.

But as the banners at last week’s mHealth Summit pointed out, we’re headed for the era of the mHealth ecosystem, a world were all the various pieces needed to make patient generated data relevant are in place. That means good things for the future health of all patients, not just fitness nuts.  In fact, a Swiss analyst firm is predicting that smart wearable devices will save 1.3 million lives by 2020, largely through reductions in mortality to in-hospital use of such devices, according to mobihealthnews.

New research from Switzerland-based Soreon Research argues that smart wearables, connected directly with smart devices, projects that using wearables for in-hospital monitoring will probably save about 700,000 lives of the 1.3 million it expects to see preserved by 2020. Even better, wearables can then take the modern outside the hospital. “New wearable technology can easily extend monitoring functions beyond the intensive care unit and alert medical professionals to any follow on medical problems a patient may develop,” according to Soreon Research Director Pascal Koenig.

Not surprisingly, given their focus on monitoring aerobic activities, Soreon projects that wearables can be particularly helpful in avoiding cardiovascular disease and obesity. The firm believes that monitoring patients with wearables could prevent 230,000 deaths due to cardiovascular diseases, and reduce obesity related deaths by 150,000.

And that’s just a taste of how omnipresent wearables use may be within a few years. In fact, Soreon believes that patients with chronic conditions will help push up the smart wearables market from $2 billion today to $41 billion, or more than 1000% growth. That’s a pretty staggering growth rate regardless of how you look at it, but particularly given that at the moment, clinical use of smart wearables is largely in the pilot stage.

What few if any pundits are discussing — notably, as I see it — is what software tools hospitals will use to crunch this flood of data that will wash it on top of the astonishing volume of data EMRs are already producing.

True, at the mHealth Summit there were vendors pitching dashboards for just this purpose, who argued that their tools would allow healthcare organizations to manage populations via wearable. And of course tools like Apple HealthKit and Microsoft Health hope to serve as middlemen who can get the job done.

These solutions will definitely offer some value to providers. Still, I’d argue that wearables will not make a huge impact on clinical outcomes until the day what they produce can be managed efficiently within the EMR environment a provider uses, and I don’t see players like Epic and Cerner making big moves in this direction. When the mHealth ecosystem comes together it’s likely to produce everything analysts predict and more, but bringing things together may take much longer than they expect.

To-Do List for Making Your Mobile Devices HIPAA Compliant

Posted on March 3, 2014 I Written By

The following is a guest blog post by Joe Grettenberger, HIPAA Security Analyst with HIPAA One.
Joe Grettenberger
Mobile device use in the workplace is becoming more commonplace today, and this is true with many healthcare professionals. Staff members can now more easily communicate through text message or iChat and quickly look up and share a patient’s health information or status through mobile devices.

But it’s also true that the increased use of mobile devices leads to an increased chance of healthcare providers being at risk of protected health information being seen or stolen by unauthorized people, which in turn means an increased chance of dealing with HIPAA compliance issues.

Follow these steps below to ensure your healthcare business and its mobile devices are HIPAA compliant.

  1. Perform a mobile device environment inventory (including all applications, ICT services & security services expected) and risk assessment that includes system threat models per SP 800-124 R1.
  2. Create an “approved mobile device” policy for the company that specifies what approved mobile devices are.
  3. Configure applications and systems that make up the mobile device environment (client & server side) and the mobile devices themselves per the policy (e.g. disable USB ports on laptops & desktops that connect to company network, lock mobile device SIM cards, etc.  See more suggestions below.)
  4. Carefully evaluate current solutions and add mobile device management and mobile device protection software that make sense.
  5. Run a pilot, test it and roll out when the risks are acceptable.
  6. Educate/train users on their portion (their responsibilities) of mobile device security.
  7. Monitor the policy.
  8. Enforce the policy with appropriate sanctions for mobile device security incidents.

Additional suggestions to step 3 are:

Use and activate a phone passcode or some other type of user authentication. All mobile devices allow for a password, PIN, or passcode to be set up before a user can access that device. Typing that information in provides user authentication for that device. Make sure your password, PIN, or passcode is strong so it’s hard for someone to guess it. It’s also wise to keep it a secret and not store it in your mobile device. You can also set up a screen lock so your device locks and requires inputting your user authentication again after a short amount of time of not being used. Doing these things prevents unauthorized access to your mobile device.

Set a required login for apps and research each app before downloading. Some apps save your information after you’ve logged in once, which is convenient because you don’t have to input that information every time you open it. But that also makes it easier for someone who gains access to your phone to gain access to protected health information. Any app you use that stores or delivers this private data should have its settings set to require a login each time you try and open the app. Be sure to also research apps before you download and install them on your mobile device. Verify that each app only performs functions you agree to so you don’t put yourself or your healthcare company at risk.

Install and authorize encryption. Encryption converts your data into a form that can’t be read without a password or the decryption key. You can encrypt data that’s stored on and sent by your mobile device. If your mobile device has an encryption capability, then enable it. If it doesn’t, then download an encryption app. To protect data sent to your device, use a secure browser connection or a virtual private network. When you encrypt data on your mobile device, you prevent unauthorized access to that data.

Install and activate remote wiping or disabling. Remote wiping lets you erase data on your mobile device remotely if for any reason it gets lost or stolen. Remote disabling lets you remotely lock your device or erase the data stores on that device. If and when you recover your device, you have the ability to unlock it with remote disabling. Using one or both of these security tools is quite valuable. No one plans on losing or having their mobile device stolen, but sometimes it happens, and with these security tools you’re able to safeguard any protected data on your device.

Install and enable a personal firewall and security software. A firewall protects your mobile device against unauthorized connections. It intercepts any incoming or outgoing connection attempt and then blocks or permits each attempt based on certain guidelines. Security software protects your device against any malicious software, such as viruses and malware. Make sure to keep your software up to date though. You can enable a personal firewall and security software if your mobile device has them, or you can download and install both if needed. These protect the private health information on your phone and help keep certain information from being accessed by the wrong person.

Keep physical control of your mobile device. Because mobile devices are smaller in size and easily portable, they’re also easily lost or stolen. To keep your device and the confidential information on it secure, always try and keep it with you, don’t let others use it, and keep it safely put away when you’re not using it. All these things help with the prevention of unauthorized user access to your mobile device and the data on it.

Mobile device use with healthcare professionals is only going to continue rising, so it’s extremely important to take all the necessary measures to safeguard your patients’ health information with all mobile phones, tablets and laptops. Following this to-do list will make sure your mobile device is HIPAA compliant, and it will keep you, your mobile device, your healthcare company, and all your patients’ health information protected.

Also see OWASP’s Top 10 Mobile Controls and Design Principles:

https://www.owasp.org/index.php/Projects/OWASP_Mobile_Security_Project_-_Top_Ten_Mobile_Controls

Extra:  The following recommendations are adapted from the 2012 CIS Google Android 4 Benchmark:

  1. Update ‘firmware’ to latest version
  2. Enable ‘password’
  3. Enable ‘Require alphanumeric value’
  4. Set ‘timeout…’ for ‘Sleep’ after 5 seconds
  5. Remove Entries in ‘Wi-Fi’
  6. Disable ‘Network Notification’
  7. Disable ‘Wi-Fi’ where unnecessary
  8. Disable ‘Bluetooth’ where unnecessary
  9. Disable ‘Location Services’ where unnecessary
  10. Enable ‘Airplane Mode’ where signal reception is unnecessary
  11. Erase all data before return, recycle, reassignment, or other disposition
  12. Disable ‘Notifications’
  13. Enable ‘Lock SIM card’
  14. Disable ‘make passwords visible’
  15. Enable ‘Encrypt phone ‘
  16. Disable ‘developer options’
  17. Disable ‘Unknown sources’
  18. Limit the ‘number of messages’ for ‘Text message limit’
  19. Limit the ‘number of messages’ for ‘Multimedia message limit’

About The Author         
Joe Grettenberger is a HIPAA Security Analyst with HIPAA One. Joe has over 25 years experience as an IT Assurance professional, with 8 years of technology auditing experience both in the public and private sectors. Joe is a certified information systems auditor (CISA) and compliance & ethics professional (CCEP). For more information about HIPAA One, please visit their website.

Market For Wireless Health Tracking Technology To Double Over Next Four Years

Posted on January 22, 2014 I Written By

Anne Zieger is veteran healthcare editor and analyst with 25 years of industry experience. Zieger formerly served as editor-in-chief of FierceHealthcare.com and her commentaries have appeared in dozens of international business publications, including Forbes, Business Week and Information Week. She has also contributed content to hundreds of healthcare and health IT organizations, including several Fortune 500 companies. She can be reached at @ziegerhealth or www.ziegerhealthcare.com.

Wondering where the market for wireless tracking devices for patients is going?  Well, according to recent research, the market should explode over the next four years, increasing from $9.6 billion in 2012 to double that within four years, according to market research firm BCC Research.

The research firm is projecting the market for such technology climb at a five-year compound annual growth rate of 16.1 percent between 2013 and 2018.

What technologies are they talking about?  Well, it’s a pretty long list, including blood glucose meters, blood pressure monitors, pulse oximetry, stress monitoring devices, pediatric growth trackers and peak flow meters.  According the report, these devices will access a variety of wireless protocols, including 3G, RFID, and Zigbee. (They don’t mention Bluetooth, but it will certainly be part of the mix as well.)

As BCC sees it, these devices are poised not only to streamline data collection and storage options, but also provide important analytical data inside and outside the hospital setting.  The firm argues that such information is extremely useful in tracking patient health, providing alerts and encouraging adherence to medication will teams.

As I see it, there’s a major divide emerging between those who see these devices in the data they deliver as central to future healthcare, and others — notably EMR-scarred doctors — who feel that they’ll be swamped with data they have no time to parse or work with.

As I’ve mentioned before, I’m doubtful that this cornucopia of data will do the good it can until some sort of middleware emerges to filter this incoming tidal wave of data.  But I do think will find a solution soon enough, and then these devices will really shine.

Deploying WiFi For Clinicians, Hospital Guests A Complex Problem

Posted on December 3, 2013 I Written By

Anne Zieger is veteran healthcare editor and analyst with 25 years of industry experience. Zieger formerly served as editor-in-chief of FierceHealthcare.com and her commentaries have appeared in dozens of international business publications, including Forbes, Business Week and Information Week. She has also contributed content to hundreds of healthcare and health IT organizations, including several Fortune 500 companies. She can be reached at @ziegerhealth or www.ziegerhealthcare.com.

These days, offering WiFi for both hospital visitors and clinicians is pretty much de rigeur. The problem is, clinicians need different things from their Wi-Fi connection than consumers do. And as a recent story in Healthcare IT News notes, that can make it difficult to keep up with everyone’s demands.

According to Ali Youssef, senior clinical mobile solutions architect at Detroit-based Henry Ford Health System, maintaining a wireless network that suits everyone’s needs is “moving target.”

Youssef was responsible for planning and implementing the HFHS wireless network, which included expanding coverage from 4 million to 8 million square feet. What’s more, the network rollout had to take into account the needs of the HFHS enterprise EMR system, according to the HIN piece.

For Youssef, one of the most difficult problems health IT managers face in this situation is provisioning bandwidth appropriately to all the different types of devices that will share the bandwidth.

Not surprisingly, Youssef believes that one of the most important ways to see that everyone has enough bandwidth is regular contact with the system’s clinicians.

In some situations, clinicians may need far more bandwidth then the IT department had anticipated, for example, where clinician is launching a new project fueled by grant money, notes the Healthcare IT News piece. (We’re also increasingly see a growing list of wireless medical devices, such as wireless glucometers, edge into mainstream clinical care.)

To cope with these rapidly changing demands, Youssef recommends planning for a high level of wireless system redundancy and conducting site surveys.

And in what may be a more difficult challenge, he recommends that network architects keep continuous tabs on what types of devices are going to be used, and testing them see how they behave on their health system’s network.

Youssef didn’t offer any detailed advice on how to accommodate hospital visitors in this story, but clearly, they will pose a significant challenge to any hospital network architect as well.

Particularly as apps become part of patients’ health system experience, network architects will need to bear consumer experience of the network in mind as well. It will be interesting to see, over the next few years, whether consumer wireless health use demands a fresh approach to network architecture generally.

HIMSS: The FDA Should Tread Carefully With Health IT Oversight

Posted on November 12, 2013 I Written By

Anne Zieger is veteran healthcare editor and analyst with 25 years of industry experience. Zieger formerly served as editor-in-chief of FierceHealthcare.com and her commentaries have appeared in dozens of international business publications, including Forbes, Business Week and Information Week. She has also contributed content to hundreds of healthcare and health IT organizations, including several Fortune 500 companies. She can be reached at @ziegerhealth or www.ziegerhealthcare.com.

Of late, the FDA has been looking at into how it will regulate health IT generally, and EMRs especially, under the authority of the Food and Drug Administration Safety Innovation Act of 2012.  This, of course, has the vendor community very nervous, as they’re not eager to have an agency as powerful as the FDA breathing down their neck.

In an effort to soften the blow somewhat, the chairman  and CEO of HIMSS  have written a letter to HHS outlining why health IT products, especially EMRs, have unique functions and requirements.

In the letter, they argue that any regulatory efforts that are made should have the following characteristics:

• Holistic Approach: Any regulatory or oversight framework should recognize that health IT is part of a complex patient care ecosystem involving providers, product developers, vendors, a  wide array of use cases, and consumers as patients and caregivers.
• Shared Responsibility: The safety and efficacy of health IT as it fits within the patient care
system can be enhanced through non-punitive surveillance and reporting systems based on mutual trust and shared responsibility by all participants.
• Clear Oversight Direction: Clear and consistent guidance regarding proposed regulatory and/or  oversight activity is essential to ensure that health IT can continue to provide the innovation and tools necessary to achieve the patient safety and quality improvement goals, and cost efficiencies sought by all stakeholders.
• Role of Intended Use/Functionality: Regulation and oversight actions should be based on the  intended purpose and intended user of a particular product or service.

Cutting a nice wide path for EMRs and related clinical data systems, HIMSS argues that health IT products largely used for transmission, storage and management of data should not be considered medical devices. The execs also argue that there’s a big difference between products which are “integral to the functioning of a medical device,” and those that communicate with such devices. (While there’s definitely a move on to integrate EMRs and medical devices, progress has been scant to date.)

We’ll see how successful HIMSS was at shaping the FDA’s expectations next year, when the agency releases a joint report outlining its strategy in cooperation with the FCC and ONC.

In the mean time, the three agencies have formed a workgroup under the ONC’s HIT  Policy Committee which will provide recommendations to the Health IT Policy Committee.  If you’re as worried as HIMSS is, and there’s no reason not to be, the workgroup may offer a chance to make your voice heard. Getting involved, or at least commenting on draft report docs, is probably a good idea.