Intouch Health Announces New fda 510(k) Clearance For Its Remote Presence Acute Care Telemedicine Devices

InTouch Health, the world's premier provider of acute care telemedicine solutions, has received a new Food and Drug Administration (FDA) 510(k) clearance with expanded indications for use for its range of Remote Presence devices which includes RP-7i®, RP-Lite®, RP-Vantage® and RP-Xpress® as well as VisitOR1® which is sold by and is a registered trademark of Karl Storz. The expanded indications for use clear InTouch Health's Remote Presence devices for active patient monitoring in high acuity environments where immediate clinical action may be required. The clearance specifically allows InTouch Health's Remote Presence devices to be used for pre-, peri-operative and post-surgical, cardiovascular, neurological, pre-natal, psychological and critical care assessments and examinations.

This clearance is part of InTouch Health's regulatory commitment to increase its level of compliance with the FDA February 14, 2011 announcement regarding Medical Device Data Systems (MDDS). The MDDS final rule provides clarification on the critical difference between the handling of medical device data intended simply for documentation versus that of active patient monitoring. The FDA indicated in its press release that MDDS classified devices are intended only to transfer, store, convert from one format to another according to preset specifications, or to display medical device data. The Final Rule further stipulates that as an FDA class I device, an MDDS is not intended to be used in connection with active patient monitoring (i.e. real time, active or online patient monitoring).

Any device that transmits, stores, converts, or displays medical device data that is intended to be relied upon in deciding to take immediate clinical action by a health care professional is not an MDDS. Active patient monitoring solutions, such as InTouch Health's telemedicine devices, are primarily FDA class II medical devices requiring more stringent manufacturer controls. The MDDS final rule is published in the Code of Federal Regulations 21 Part 880, Docket No. FDA-2008-N-0106. The MDDS final rule also states if a third-party company or hospital (i) develops its own software protocols or interfaces that have an intended use consistent with an MDDS, or (ii) develops, modifies, or creates a system from multiple components of devices and uses it clinically for functions covered by the MDDS classification, then that entity would also be considered a device manufacturer and be subject to FDA regulations.

“With these expanded indications for use, InTouch Health's platform of telemedicine devices now has clearance for active patient monitoring in high acuity clinical environments with specific language clarifying the allowance of clinical applications of importance to customers in our core TeleStroke and TeleICU markets,” said Dr. Yulun Wang, Chairman and CEO of InTouch Health. “This clearance raises the bar for regulatory compliance in acute care markets and we are proud to have achieved this regulatory objective. We are absolutely committed to stringent regulatory compliance, and we are pleased to provide customers the assurance of knowing that our telemedicine solutions have withstood vigorous testing and are fully compliant with FDA regulations.”

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mHealth Alliance to Receive $1 Million From HP to Improve Health Through Mobile Technology

mHealth Alliance Board welcomes HP as Founding Partner

The mHealth Alliance today announced a two-year, $1 million aggregate donation from HP to help improve health care and health systems around the globe using mobile technology. The announcement was made at the opening of the mHealth Summit, a three-day event bringing together leaders from the global health and technology communities to explore ways mobile technology can increase the access, quality and efficiency of healthcare to communities in the U.S. and abroad.

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HTM Speaks with Dr. Adam Chee, Chief Advocate binaryHealthCare

 

Dr. Adam Chee has several years of professional working experience in the IT industry before venturing into Health IT in 2002 where he specialized in Medical Imaging Informatics and related technologies before moving onto the wider spectrum of Healthcare Informatics. An active contributing member to several international Technology and Health IT initiatives, Adam runs binaryHealthCare, a social enterprise advocating Health ITas an enabler for “better patient care at lower cost” by raising the standards of health informatics through training, continuing education and providing a vendor neutral community for knowledge exchange and collaboration.

A recognized subject matter expert on the area of Health IT, Adam is an experienced conference speaker, adjunct faculty with institutes of higher learning (on health informatics) and serves on several Technical and Health Informatics committees. “Healthcare Informatics has not only become an integrated part of modern healthcare but has also propagated the entire industry into a new era of efficiency and it will continue to play avital rolein the quest of providing quality health services. The potential for Healthcare Informatics is colossal and the growth is right here in Asia Pacific.”

Please introduce yourself, your background and your current role within the healthcare information technology industry:

My training and background has predominantly been in the area of Information Technology and Healthcare Informatics and I am a lifelong learner who has never pause in the quest for knowledge in areas related to work and interest. I have worked across a broad spectrum of healthcare informatics in terms of perspective (from the healthcare provider to solution provider as well as consulting, research and education aspects etc) as well as the industry segments (from primary care informatics to CDSS, EMR, Tele-medicine and of course medical imaging informatics etc).

I am a firm believer and advocate on the importance of Health IT as an enabler for “better patient care at lower cost” and I take action through binaryHealthCare by raising the standards of health informatics through training, continuing education and providing a vendor neutral community / hub to enable knowledge exchange and collaboration. The work done though binaryHealthCare is important because if an adopter of healthcare informatics ‘don’t know what they don’t know’, then how can a successful implementation takes place? How can the clinicians and most importantly, the patients, benefit from the implementation?

What are the driving forces behind the demand for Healthcare Informatics in the Asia Pacific?

Asia Pacific is an extremely huge region so it is difficult to generalize the unique driving forces behind the demand for Healthcare Informatics but in general, it includes; -Medical tourism (patient safety and quality of care) -Rapid aging population (tele-health / remote and home monitoring) -Preventive care (public health, surveillance and containment) -Lack of qualified professionals (lured to work overseas or simply shortage of qualified professionals in rural area) -and of course, cost savings

How has the market place grown and developed in the last 5 years?

The health informatics industry in Asia has definitely undergone tremendous changes over the past 5 years, while the adoption rate varies tremendously throughout the region, it is clear that the industry in this region now process greater awareness and knowledge on the benefits that an effective health informatics implementation can bring to their healthcare enterprises as well as the common pitfalls to avoid. At the same time, the rising affluency in this region also means that the desirable solutions that was previously out of reach is now affordable.

Explain the emerging technologies that are redefining the delivery of healthcare today:

The introduction of new generation tablets, advances in unified communications and cloud computing will definitely redefine the rules and boundaries. Mobility is the key word here. The finer convergence of relevant industry Standards is also taking shape and this is important because the individual silos of data stored in disparate or extremely loosely coupled information systems needs to be consolidated in a structured and interoperable format that allows integrated care to take place so effective utilize of data for trending, profiling and most importantly, preventive measures can happen. The goal and focus in many developed countries has also shifted to the utilization of healthcare informatics in primary and community care as well as public health as opposed to diagnostic care - Prevention is better than cure.

How can international healthcare technology providers position themselves within the Asia Pacific and what business opportunities exist?

The pace of adoption for healthcare technology varies tremendously across the Asia Pacific region but it is evident from the increasing demands in this region that there exist an abundance of opportunities for providers of all ‘shapes and sizes’, it’s a matter of finding the right fit for both sides. The raising affluency and hunger for knowledge in this region is amazing and this is the right place to be for those truly passionate about utilizing technology to enable effective healthcare while lowering cost for patients. For international healthcare technology providers, it is important that they understand that the healthcare systems in Asia Pacific can vary dramatically and whatever ‘success formula’ that brought them to fame in their home country / region may very well be their Achilles heels in this region.

Do not operate out from an ivory tower, it is important to take the time and effort to understand the unique characteristics and culture of each country of interest and most importantly, the need to build trust and understand that the sales cycle can be very long. Demonstrate the commitment to show that they are not in for the short-term but rather, the willingness to form a true partnership with the healthcare enterprise in their journey towards healthcare technology adoption. E.g. what sort of support commitment are you offering? Are you establishing any R&D centers in the region?

Recently on linkedin.com it was asked “what are the major reasons that EMR/EHR implementations fail; what do you think?

It is important to first understand that healthcare systems differ from counties and workflow differs from healthcare enterprises (even within the same state/country). An EMR/EHR implementation will have a huge impact on workflow and it is important that this aspect is addressed properly; in addition, I cannot emphasis enough on the need for proper expectation management. Focusing on the important aspects will mitigate the chances of failure. I know it’s easier said than done but it is possible.

What do hospital providers want and what do they get?

The typical hospital provider really just wants to see a return of investment, this can range from operational efficiency, workflow improvement, lowering operating cost, manpower reduction and increase in patient safety and quality of care, the bottom line is, it must be money well spent. The good news is, hospital providers will (most of the time) get some form of value from health informatics projects but the bad news is, these value might not be proportional with the investment made, be it time, money and efforts. The success level really depends on the expectation management (was the project oversold?) and whether the projects are implemented properly. Half a crooked bridge serves no real valuable purpose at all.

Asia Pacific is a vast region of the world. How can information technology bridge the digital divide faced in rural healthcare service delivery, in countries like China?

For large regions where delivery of healthcare services in rural areas can be a challenge, the adoption of tele-medicine technologies can definitely help bridge the gap. However, it is more important to first have the approval and support by the government and ensure that any policies and regulations issues be ironed out. For example, how would the rei