HAPPTIQUE CEO TESTIFIES IN DC ON
THE REGULATION OF MOBILE HEALTH APPS

Supports Continued FDA Role in the Regulation of Mobile Health Technology; Opposes Medical Device Tax on Mobile Devices and Mobile Health Applications

Washington, D. C. – In a hearing today by the U.S. House of Representatives’ Energy and Commerce Subcommittee on Communications and Technology on the regulation of the mobile health (mHealth) application market, Benjamin M. Chodor, Chief Executive Officer of Happtique, Inc., addressed questions relating to the regulation of the rapidly-growing mobile health market. The hearing, “Health Information Technologies: Harnessing Wireless Innovation,” is the first of three hearings on health information technology scheduled for this week by various Energy and Commerce Subcommittees.

Noting that more than 40,000 health apps exist on the market to assist healthcare professionals deliver and improve patient care, Chodor said, “Of course, this raises the issue of who should monitor the mobile health industry. The mHealth community is in need of both direction and a level of expectation to foster innovation while assuring safety and effectiveness. Happtique believes that the industry would benefit from a balanced, risk-based approach where regulation and oversight is borne by various appropriate groups and that is clearly conveyed to all stakeholders.”

Chodor expressed support for the definition of “mobile medical app” that the Food and Drug Administration (FDA) included in its July 2011 Draft Guidance and the examples of mobile medical apps that the FDA plans to include in its regulatory oversight. He said, “Happtique echoes the concerns of the FDA with respect to technologies that pose significant risk and may fall under their surveillance.” Thus, Happtique believes that the FDA is the best-positioned Federal agency to regulate health apps because of its deep expertise on issues of patient safety. Its risk-based approach strikes an appropriate balance for guarding against consumer harm, while not chilling technological innovation, and because it is the most prepared to regulate this technology. But Chodor cautioned that he and Happtique “don’t believe that the FDA should regulate mHealth products that are not considered to be medical devices. The FDA provided clarity in the Draft Guidance as to which mobile apps they do not anticipate classifying as mobile medical apps for purposes of regulation. Happtique agrees with the exclusions.”

The Subcommittee is also looking at the question of whether the medical device tax included in the Affordable Care Act (ACA) applies to mobile devices and mobile health applications. Addressing this issue, Chodor said, “We are opposed to its imposition on the sale of smartphones, tablet devices and apps used by any type of individual in any setting or circumstance. We do not believe that it was the intent of Congress to impose the excise tax on iPhones, iPads, Android phones or tablets, or Blackberries, and certainly not on related applications that run on those devices.”

Internal Revenue Service regulations issued in connection with this ACA provision provide for a so-called “retail exemption,” which exempts any device of a type that is generally purchased by the general public at retail for individual use. Thus, Chodor said, “A fair reading of the final regulations implementing the tax should lead one to conclude that the retail exemption applies to all smartphones and tablets on the market today. A physician’s use of an iPhone to treat or diagnose a patient that has been regulated by the FDA as a mobile medical app does not change the nature of the iPhone from a consumer device sold to the general public at retail to a medical device subject to the medical device excise tax.”

Chodor also described to the Subcommittee Happtique’s Health App Certification Program (HACP), which Happtique began developing more than a year ago and is expected to launch this spring. Given the FDA Draft Guidance’s clarity on the apps that it will regulate, Happtique and other industry stakeholders estimate that only about 20% of all medical and health apps would fall subject to FDA regulatory oversight. Chodor said, “Happtique’s voluntary Health App Certification Program is borne out of the expressed need by many healthcare organizations and clinicians to identify technically and substantively valid apps.” Given the tens of thousands of apps in the market not subject to FDA regulation, Chodor noted that “because there is not a reliable way for app users to readily distinguish credible apps from all others, Happtique saw the need for an objective app assessment and validation process.”

Happtique recently published the Standards and Performance Requirements that will be used to evaluate apps. The Standards encompass four areas: Operability, Privacy, Security (collectively referred to as the “Technical Standards), and Content. In total, there are nearly 150 Standards and Performance Requirements that an app must pass in order to be certified. The Standards and Performance Requirements are explicitly designed as a complement to the FDA regulatory framework and will be updated as needed. They are also designed to take into consideration requirements of other key Federal agencies, including the Federal Trade Commission, Federal Communications Commission, and the Office of the National Coordinator for Health Information Technology.

Under the HACP, Intertek, an internationally recognized leader in the provision of testing, inspection, certification, and auditing services to a wide range of industries and in the mobile app space, will conduct the testing against the HACP Technical Standards. Apps that pass the technical assessment will then be reviewed to validate their content. To evaluate content, Happtique has partnered with the Association of American Medical Colleges to review medical education and patient education apps, and CGFNS International to review nursing apps. Discussions are now underway with numerous other organizations that will provide content experts for the many other types of apps that are expected to seek certification.

Chodor noted that much certification and accreditation in healthcare is private-sector based. Happtique is well-suited to undertake this role and can play a critical part in assuring the quality of apps used by clinicians, patients, and consumers.

ABOUT HAPPTIQUE
Happtique is an mHealth solutions company whose mission is to help integrate mobile health into patient care and daily life. The company’s mRx™ Mobile Platform empowers healthcare providers to prescribe mobile health apps and engages patients to take an active role in the monitoring and management of their personal health. Happtique operates a Health App Certification Program to help healthcare providers and consumers easily identify apps that deliver credible content, contain safeguards for user data, and function as described.

For the latest developments in mHealth visit Happtique.com or tune in to our weekly Internet radio show mHealth Zone Live. Follow Happtique on Twitter, LinkedIn, or Facebook.

Happtique Publishes Final Standards for
Mobile Health App Certification Program

Association of American Medical Colleges, CGFNS International and Intertek to Serve as Content and Technical Review Partners

NEW YORK, NY – Feb. 27, 2013 – Happtique, an mHealth solutions company, today announced the publication of the final Standards it will use to certify apps under the Happtique Health App Certification Program (HACP). The HACP will help healthcare providers and consumers easily identify medical, health, and fitness apps that deliver credible content, contain safeguards for user data, and function as described. The final Certification Standards and associated Performance Requirements, which assess operability, privacy, security, and content, can be read at http://www.happtique.com/app-certification/.

Happtique also announced that the Association of American Medical Colleges (AAMC), CGFNS International, and Intertek will serve, according to their respective subject matter expertise, as HACP Partners responsible for the evaluation of health apps against the Certification Standards.

“The vast sea of mobile health apps—over 40,000 across all platforms—can be overwhelming,” said Ben Chodor, CEO of Happtique. “Healthcare professionals and consumers need third-party certification to verify that the app they are prescribing or downloading delivers credible content, contains safeguards for user data, and functions as described.”

In July 2012, Happtique released a set of draft Certification Standards and associated Performance Requirements that were developed under the direction of a Blue Ribbon Panel with input from many private organizations and representatives of key Federal agencies whom Happtique met with, including: mHIMSS, U.S. Food and Drug Administration (FDA), Federal Communications Commission (FCC), Federal Trade Commission (FTC), and the Office of the National Coordinator for Health Information Technology (ONC). While the final Certification Standards reflect this valuable collective feedback, and input provided during the public comment period, it does not represent their approval or endorsement.

“With mHealth’s footprint and importance rapidly expanding, we can expect a proliferation of health apps that will need careful review from expert stakeholders,” said Lee Perlman, President of GNYHA Ventures, Inc. and Managing Director of Happtique. “The Happtique Certification Standards will not only complement the objectives of key Federal agencies involved in the regulation of mobile health apps, but also raise the bar for a growing segment of apps that are currently not subject to heightened regulatory oversight.”

Internationally Recognized Organizations to Collaboratively Conduct Mobile Health App Evaluation
AAMC, CGFNS International, and Intertek have partnered with Happtique to serve as HACP Partners responsible for the evaluation of apps against the Certification Standards.

“We are honored to partner with such prestigious organizations,” said Chodor. “The involvement of AAMC, CGFNS International, and Intertek will provide healthcare providers and consumers added assurance that Happtique Certified apps have undergone testing and review by experts in their respective fields.”

The testing of the Technical Standards will be conducted by Intertek, a global leader in the provision of testing, inspection, certification and auditing services. Intertek was selected as the HACP Technical Testing Partner after an extensive RFP process.

App evaluation for the Content Standards will be conducted under the auspices of internationally recognized thirty party organizations, including AAMC and CGFNS International, and performed by clinical specialists selected based on the mobile app’s specific subject matter. Happtique will continue to expand its HACP Content Review Partners and is currently in discussions with a number of organizations with various areas of clinical expertise.
• AAMC, represents all 141 accredited U.S. medical schools, nearly 400 major teaching hospitals and health systems, and nearly 90 academic and scientific societies, will conduct the content evaluation for apps related to medical education
• CGFNS International, a global authority on credentials evaluation of the education, registration and licensure of nurses, healthcare and other professionals worldwide, will conduct the content evaluation for mobile nursing applications
After an app successfully meets all of the Happtique HACP Standards and associated Performance Requirements, it will be granted Happtique Certification. Certification is valid for a two-year period and is specifically associated with the app version that was submitted for evaluation.

App developers planning to submit their medical, health or fitness app(s) should register for a HACP Submission Form. As soon as Happtique and its Program Partners are ready to accept submissions, registrants will receive a link to the HACP Portal where they can submit their application.

ABOUT HAPPTIQUE
Happtique is an mHealth solutions company whose mission is to help integrate mobile health into patient care and daily life. The company’s mRx™ Mobile Platform empowers healthcare providers to prescribe mobile health apps and engages patients to take an active role in the monitoring and management of their personal health. Happtique operates a Health App Certification Program to help healthcare providers and consumers easily identify apps that deliver credible content, contain safeguards for user data, and function as described. For the latest developments in mHealth visit Happtique.com or tune in to our weekly Internet radio show mHealth Zone Live. Follow Happtique on Twitter, LinkedIn, or Facebook.

# # #
Media Contacts:

Tammy Lewis | 914-400-4376
TLewis@Happtique.com

Leslie Chasky | 212-691-2800
Chasky@SunshineSachs.com

Nov. 27, 2012

NEW YORK, NY – Happtique, the digital platform for the curation, certification, and prescribing of mobile health apps, today announced the addition of nine key staff, including the appointment of Lois Drapin as Chief Verticals Officer and Tammy Lewis as Chief Marketing and Strategy Officer, effective immediately. Drapin and Lewis will join the company’s executive team and report to Happtique Chief Executive Officer Ben Chodor.

“Lois Drapin and Tammy Lewis have the leadership, experience, and proven record to drive forward our goal to incorporate mHealth into daily workflow and patient care and position the company as a transformational force in the mHealth world,” Chodor said. “We have assembled an outstanding group, and I’m thrilled to welcome all of our new staff.”

Lois Drapin is responsible for corporate development, business partnerships, and strategic alliances. A veteran healthcare entrepreneur and advisor to senior executives, CEOs, and their investors, Drapin has been working strategically with Happtique for the past 18 months. She previously advised pharmaceutical and emerging digital and mobile health companies in the areas of social media, big data, medical education, market research, and remote patient monitoring. Drapin has provided strategic guidance to Johnson & Johnson , United Healthcare, Physicians Interactive, Skyscape, and Healthline Networks. Additionally, Drapin served as the first member of the Innovation Group at Wyeth and as Senior Vice President of Strategic Development at Synetic, CareInsight, Medical Manager, and ultimately for WebMD. Prior to her healthcare career, Drapin pioneered fully credentialed undergraduate and graduate programs in U.S. state and federal correctional facilities in partnership with public and private colleges and universities for nearly a decade.

Tammy Lewis is responsible for strategic marketing, brand development, and marketing communications. A 20-year healthcare marketer, Lewis most recently served as Chief Marketing Officer at Skanz, the first QR-coded social network. She previously served as Chief Marketing Officer at Prematics (now NaviNet), a provider of mobile care management solutions, and was the founding Chief Marketing Officer at Surescripts, operator of the nation’s largest health information exchange. During her six years at Surescripts, Lewis was responsible for the development of the company’s go-to-market strategy and brand development, and the creation of breakthrough marketing and communications programs, including the annual SafeRx Awards, the GoldRx Advanced Certification Program, and the Get Connected Campaign. Additionally, Lewis served as Senior Vice President of Marketing at Medscape and Marketing Director of the HIV Franchise at Hoffmann La Roche, where she launched the first protease inhibitor.

During November, Happtique added nine full-time employees to its staff, including Sandra Maliszewski, Director of the Happtique App Certification Program. The company’s final standards and the operating policies and procedures of the App Certification Program will be available in the first quarter of 2013.

About Happtique
Happtique is the digital platform for the curation, certification, and prescribing of mobile health apps. Happtique offers hospitals and heathcare enterprises the ability to define an mHealth app formulary and create their own white label, health application stores for providers and patients. Happtique helps further incorporate mHealth into daily workflow by allowing physicians and other care providers to prescribe health apps via its patent-pending, secure, developer-agnostic platform. In early 2013, Happtique will launch its App Certification Program to help physicians, patients, and other mHealth consumers identify apps that have reliable content and meet high operability, privacy, and security standards. Happtique is a subsidiary of GNYHA Ventures, Inc., the business arm of the Greater New York Hospital Association. Follow Happtique on Twitter, LinkedIn, or Facebook.

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November 7, 2012

Last week parts of the East Coast were devastated as Hurricane Sandy displaced families, destroyed homes, and wreaked havoc on healthcare facilities. Although I live in lower Manhattan and didn’t have power for almost a week, I consider myself one of the lucky ones. Why? Because I was able to manage my health despite the general state of emergency.

I’ve lived with—and successfully managed—a chronic disease for years. Nonetheless, my health is always in the back of my mind and therefore, the events of last week really got me thinking: How are other chronically ill patients coping? Where do these folks turn during a natural disaster, presuming they don’t need a hospital or emergency medical attention? You might be holding the answer in your hand: mobile health apps.

During emergency situations, patients with chronic—but not urgent—medical needs may not be able to access their healthcare providers as easily. Or, perhaps family members might be especially concerned that these patients aren’t able to manage their health in the absence of daily routine and scheduled appointments.

So what apps can help folks cope? Simply sorting by “apps for patients and consumers” in the Happtique app catalog – I came up with a few essential topics that might pertain to an emergency situation:

Medication Tracker Apps: It’s no secret that medication compliance is a huge issue–studies show 75% of adults do not consistently take prescribed medications. When a significant disruption in daily routine occurs, like a major weather event, those statistics worsen. Medication tracker applications remind users to take their pills and help them keep track of their meds.

Disease Management Apps: Approximately 1 in 10 Americans are living with a chronic disease today. Anyone who has a chronic condition knows that managing your disease on a regular day can be difficult, never mind when you’re in the middle of a natural disaster! Disease management apps help users both track their symptoms and better manage their disease. Other features can include medication reminders and automatic alerts to caregivers and/or providers. If these apps are connected back to healthcare providers, physicians and other clinical staff can help monitor at-risk patients remotely.

Mental Health Apps: Not surprisingly, folks who suffer from mental health issues are at higher-risk for urgent health problems during emergency situations; however, anyone can develop mental health issues following the stress of traumatic incident, such as natural disasters. Depending on your current diagnosis, there are a variety of mental health apps that do everything from screen and check your symptoms, track your mood, and provide tested treatments.

Emergency-Related Apps: Of course anyone can become a victim during a natural disaster and therefore, nothing is more critical than emergency care. Emergency-related apps provide users with critical information utilities and other resources, important transportation info, links to urgent care, and some even allow you to store your personal health information in case your medical files can’t be accessed from your regular healthcare provider. Obviously, apps don’t—and shouldn’t—replace 9-1-1 for actually emergency care, but they certainly can provide access to important, up-to-date information when dealing with a storm and its aftermath.

I think we can all agree that health apps are playing an increasingly significant role in improving people’s health—and empowering patients to manage their own wellbeing. In the aftermath of Hurricane Sandy, these tools seem even more valuable during emergency situations. The storm alone propelled emergency care app Hurricane by the American Red Cross to number 3 in the Apple app store! So, when a storm is headed your way, you might want to add a visit to the app store to your prep list.

And one final thought: For these types of tools to help in an emergency, your smartphone needs power—so make sure you charge your phone early and often!

Happtique, a mobile health application store and total app management solution, today announced the commencement of its pilot program of mRx™, Happtique’s patent-pending solution that enables physicians and other health practitioners to electronically prescribe medical, health, and fitness apps to their patients. mRx™ is designed to improve communications between practitioners and their patients, patient engagement and adherence, and ultimately patients’ health.

“Happtique is pleased to officially launch the mRx™ Pilot Program. Given the tens of thousands of medical, health, and fitness apps on the market today, patients need guidance from health care professionals as they select and use these apps to manage their health. We also firmly believe that app prescribing will prove an effective tool for facilitating positive patient behavior change, which will foster self-management and monitoring and ultimately result in improved health outcomes and lowered health care costs. We welcome the participation of health care practitioners across the U.S. in our mRx™ Pilot Program and look forward to receiving their feedback on mRx,” said Ben Chodor, Happtique’s CEO.

The pilot will focus particularly on cardiology, rheumatology, endocrinology, orthopedics, physical therapy, and fitness training. For these areas, Happtique consulted a specialist in each field and reviewed relevant websites to develop a sample list of apps for each of the targeted areas. Practitioners may prescribe apps from the sample list or other apps of their choice. Licensed or certified health care practitioners in other specialties and disciplines are also welcome to participate in the mRx™ pilot. Such practitioners may include physicians in specialties other than those described previously, nurses, dietitians, therapists (i.e., physical, occupational, respiratory and speech), chiropractors, social workers, etc. Practitioners in these fields will choose the apps they wish to prescribe. The pilot will focus on the usability of mRx™ along with practitioner and patient satisfaction. While the pilot will track how many apps are prescribed and how many times the “fill” button is clicked after an app prescription is sent, it will not measure app usage or clinical outcomes.

“As a rheumatologist, it is particularly important that I work with my patients to enable them to take responsibility for their own health,” said Steven Magid, M.D., of New York-based Hospital for Special Surgery. “As the first physician to prescribe these mobile apps under this program, I am setting a path for my colleagues and patients alike to use these tools to enhance doctor-patient communication and, ultimately, patients’ health.” Specialists at Hospital for Special Surgery, a national leader in orthopedics and rheumatology, work to provide the best possible outcomes for patients with challenging diseases such as lupus, as well as those with inflammatory or degenerative arthritis.

Practitioners who are interested in participating in the mRx™ pilot must complete the mRx™ Pilot Program Practitioner Application Form. Once Happtique reviews and accepts the application, the practitioner will be sent a link and instructions on how to install the mRx app. mRx can be installed on any Apple or Android smartphone or tablet. Happtique’s mRx app comes with:

mHealth App Catalog  - a catalog that contains the apps that the practitioner will prescribe;

Patient Directory – a field that is populated automatically with the patients who are prescribed apps along with the specific apps they are prescribed; and

mRx™ – the electronic prescription form used by practitioners to prescribe apps.

When the mRx™ prescription form is completed, the practitioner sends it to the patient’s smartphone or tablet. Practitioners can track which patients have downloaded prescribed apps and send reminders to patients whose apps aren’t downloaded. At the end of the pilot program, practitioners and patients will be asked for feedback on their experience using mRx™.

mRx Pilot Program Timetable

The Pilot Program is beginning August 20^th, and is slated to run until December. The pilot consists of several phases, including practitioner enrollment, use of the mRx™ app by enrolled practitioners, and feedback.  For specific details about the timetable, click here.

Media Contact:
Leslie Chasky
Sunshine Sachs
chasky@sunshinesachs.com / (212) 691-2800

Follow Happtique on Twitter, LinkedIn, or Facebook.

August 1, 2012

Hundreds of mHealth conferences are held each year. Selecting which ones to attend can be confusing, especially when you consider the registration fees, which are often hefty. As I was fortunate enough to attend, I’ve written a review of the 4^th Annual mHealth World Congress that was held in Boston from July 25–27. My rating? Five stars. Here are four practical lessons that I took away from the conference:

1)      The FDA is not the enemy. As stakeholders in the mHealth space, we want our medical apps and devices to serve a legitimate purpose. Right now, the marketplace is taking a Darwinist approach common in most free markets—survival of the fittest or, in this case, the most popular. While that may be fine for sneakers or vacuums, it’s a little more challenging in the medical field. With patient care at stake, we can’t take a wait-and-see approach about the accuracy or legitimacy of apps. And that’s where the FDA comes in, promoting patient safety and doing so without hampering innovation. Consider the number of mobile blood-glucose testing devices and less-known dermatological apps that with a single picture of a skin lesion can pair that image to a database in the cloud and offer a self-diagnosis.  An incredible advance—if it works. But if clinicians and patients can’t rely on apps to do what they promise, mHealth will quickly lose credibility with the medical establishment.

2)      Healthcare can be fun! There is some really exciting stuff happening with the “gamification” of health.  On one of the summit panels, Jim Burns, Chief Technology Officer at Elbrys Networks, described his image of a future that incorporates gaming into the mHealth space. He envisions a system by which points or currency could be accrued for commendable fitness performance as measured by connected devices. This currency would have purchasing power in traditional mobile gaming applications. For example, if you walked 1,000 steps as measured by any connected mobile device, you might receive 1 point. You could then use those points toward perks in other gaming apps (e.g., 100 points could unlock all levels of Angry Birds).  Another speaker on the panel, Dr. Lisa Shieh, Medical Director at Stanford University Medical Center, described the app that Stanford developed regarding sepsis infections. The app, called Septris, invites physicians to read a patient case and accrue points for proper virtual treatment based on clinical standards. During the panel, Dr. Shieh presented data on the heightened knowledge about sepsis experienced by physicians who played the game, and she elaborated on ways that Stanford will further engage physicians through the game–like by creating a hospital leader board that ranks participating hospitals by their Septris scores.

3)      Behavioral science is paramount. One of the standout moments at the conference was when Dr. Victor Strecher took the podium sporting his Nike fuel band and asked, “Why is Nike Fuel so successful?”  The answer, of course, is that it is fashionable―it looks cool both with workout clothes or a tuxedo…and it acts as a watch, too.  The statement, however simple, was nonetheless an eye-opener. A similar aha moment came when Dr. Naomi Fried, Chief Innovation Officer at Boston Children’s Hospital, described the process used to develop her new Patient Passport app. The app—which helps users track their hospital experience, take notes, and recall names and faces of physicians—first began as a paper passport. Only after the paper version was deemed successful did Fried and her team decide to digitize it. The lesson here? Too often app developers create a product without adequate consumer demand. Dr. John Halamka, Chief Information Officer at Beth Israel Deaconess Medical Center, discussed the influence of behavioral psychology when describing the initiative to secure employees’ personal devices.  Admitting that hoping employees would actually follow policy protocol and secure their personal devices was too good to be true, Dr. Halamka initiated a program by which his IT staff personally secured such devices. Though the process wasn’t exactly convenient, it certainly beat the constant fear of a security breach and the expensive recruitment of a forensics team that had been required when a physician’s laptop was stolen.

4)      There is a new protocol to fund mHealth ventures. With an ever-growing number of mHealth startups, securing venture capital is becoming increasingly difficult. Firms are forced to find new ways to raise money or are forced to find new ways to prove themselves worthy of capital.  Behold crowd-funding.  Now, with sites like Kickstarter and Medstartr, firms are able raise significant amounts of capital through public investment.  Consider Erik Migicovsky, founder of Pebble Technology, who raised over $10 million from 69,000 backers in 30 days.  Admittedly, Migicovsky’s story is unusual. The real strength of crowd-funding lies in the public’s ability to back a firm with a few thousand dollars, offering proof of concept when the start-up makes its VC pitch.

Events like the Boston summit will continue to reveal important trends and clarify erroneous assumptions in this space. With continued collaboration between mHealth professionals, we can look forward to watching the mHealth world blossom and grow.

Happtique, a mobile health application store and total app management solution, today announced the release of a Request for Proposals (RFP) for vendors who have the capability to test whether medical, health, and fitness apps meet certain operability, privacy, and security standards (“Technical Standards”). The Technical Standards, along with standards that focus on app content, are the foundation of an App Certification Program that Happtique is developing to help healthcare professionals, patients, and consumers identify apps that are both technically sound and substantively valid. Earlier this week, a draft of the certification standards was released for public comment.

The Certification Program, which Happtique expects to launch later this year, is a voluntary program for apps intended for use in the U.S. Under the program, an app owner or developer will submit an app for certification via an electronic submission form that will capture information about the app’s operability, privacy, and security features and content. The app will first undergo testing to determine its compliance with the Technical Standards. Apps that pass the Technical Standards assessment will proceed to content review by a professional from the relevant field or discipline. Other details about the App Certification Program process such as submission requirements, length of certification, re-certification requirements, and fees are currently under development.

“The Happtique App Certification Program will play a key role in enabling clinicians, patients, and other mHealth consumers to identify high-quality apps. Releasing the draft standards this week was an important first step in establishing this program. Happtique looks forward to partnering with organizations that have the ability to determine whether or not an app meets the program’s Technical Standards,” said Ben Chodor, Happtique’s CEO.

Proposals, which are due on Friday, August 17, 2012, may encompass any or all three components of the Technical Standards. Contracts will be awarded to one or more qualified vendors by late October.

The RFP is available at: www.happtique.com/app-certification/app-test-rfp.

About Happtique
Happtique is a mobile health application store and app management solution that helps healthcare providers, physicians, and patients easily integrate mHealth into treatment. It offers medical enterprises—like hospitals, continuing care facilities, and physician practices—the ability to create individually branded, secure, multi-platform application stores for staff and patient use. Happtique is a subsidiary of GNYHA Ventures, Inc., the business arm of the Greater New York Hospital Association.

Follow Happtique on Twitter, LinkedIn, or Facebook.

New York, NY – Happtique, a mobile health application store and total app management solution, today released a draft of the standards that it will be using to certify medical, health, and fitness apps under Happtique’s App Certification Program. The purpose of the program is to help users identify apps that meet high operability, privacy, and security standards and are based on reliable content. The draft standards are the product of several months of deliberations by a Blue Ribbon Panel—consisting of a physician, nurse, biotechnology scientist, and patient advocate—that was formed by Happtique to oversee the development of the certification program’s standards and operating procedures.

Happtique is developing this program in response to the many health care organizations and clinicians who expressed a need for a way to identify technically and substantively valid apps. “There are tens of thousands of medical, health and fitness apps on the market and their sheer number makes it difficult for health care professionals and consumers to locate apps that operate reliably, are based on valid information, and safeguard users’ information,” said Happtique CEO Ben Chodor. “Happtique’s App Certification Program will address an important need in the mHealth field by evaluating apps along these dimensions.  We believe the certification process will lead to the identification of truly high quality apps, thereby giving health care professionals and consumers alike the confidence they need in the apps they are recommending or using.”

The Certification Program is a voluntary program for apps intended for use in the U.S. Initially, the program will focus on English language apps with additional languages expected to be added in the future. The draft standards, while not designed to determine clinical efficacy, address four areas:  Operability, Privacy, Security, and Content. Each area consists of multiple standards and associated performance requirements. In developing the standards, Happtique met with and received feedback from a number of private organizations and federal agencies, including the Association of American Medical Colleges (AAMC), Mobile Marketing Association (MMA), GSM Association (GSMA), mobile Healthcare Information and Management Systems Society (mHIMSS), Association for Competitive Technology (ACT), U.S. Food and Drug Administration (FDA), Federal Communications Commission (FCC), Federal Trade Commission (FTC), and the Office of the National Coordinator for Health Information Technology (ONC). For the critical areas of privacy, security and usability, the standards draw heavily on work that has been done by MMA, GSMA, mHIMSS, and ACT on these issues.  Finally, the standards are explicitly designed to be consistent with any guidance or rules promulgated by U.S. regulatory agencies such as the FDA, FCC, FTC, and ONC. While the draft standards reflect the very valuable feedback provided by these organizations and agencies to date, it does not represent their approval or endorsement. Further input from these entities along with input from others who have not seen earlier drafts is anticipated and welcome.

Happtique’s App Certification Program Blue Ribbon Panel is composed of the following recognized leaders in mHealth, health care technology, health care certification and accreditation programs, and patient advocacy:

• David Lee Scher, M.D., Panel Chair – former practicing cardiologist and mHealth authority
• Franklin Schaffer, EdD, RN, FAAN – Chief Executive Officer, Commission on Graduates of Foreign Nursing Schools
• Shuvo Roy, Ph.D. – Director, Biomedical Microdevices Laboratory and Associate Professor, Department of Bioengineering and Therapeutic Sciences, School of Pharmacy, University of California, San Franciso
• Dave deBronkart (“ePatient Dave”) – well-known spokesman for patient engagement

“We are pleased to invite public comments on the draft App Certification Program Standards, and we welcome feedback from organizations and professionals in the medical, health, and fitness community; app owners, developers, and publishers; patients; and consumers. Our goal is to produce a set of rigorous standards that will give both health care professionals and consumers a solid basis for selecting apps,” said Dr. Scher, the Panel’s Chair.

Comments on the draft standards can be submitted until 5:00 p.m. (Eastern Time) on Friday, August 17, 2012 at http://www.happtique.com/app-certification/.

During the comment period, the Panel will be finalizing the Certification Program’s operating policies and procedures. In general, each app submitted for certification will first undergo technical testing to determine its compliance with the Operability, Privacy, and Security Standards. Those that pass the technical assessment will proceed to content review. App reviewers will have credentials relevant and appropriate to the content being reviewed (e.g., cardiologists will review cardiology apps, nurses will review nursing apps, dieticians will review diet and nutrition apps, certified personal trainers will review fitness apps). Details of the full App Certification Program process, including but not limited to submission requirements, review procedures, feedback and resubmission opportunities for developers whose apps don’t qualify for certification, length of certification, re-certification requirements, procedures for assuring compliance with the standards between certification reviews, fees, and procedures for updating the standards will be released in the coming weeks. The program is expected launch in the fall of 2012.

About Happtique

Happtique is a mobile health application store and app management solution that helps healthcare providers, physicians, and patients easily integrate mHealth into treatment. It offers medical enterprises—like hospitals, continuing care facilities, and physician practices—the ability to create individually branded, secure, multi-platform application stores for staff and patient use. Happtique is a subsidiary of GNYHA Ventures, Inc., the business arm of the Greater New York Hospital Association.

Follow Happtique on Twitter, LinkedIn, or Facebook.

Media Contact:
Leslie Chasky
Sunshine Sachs
chasky@sunshinesachs.com / (212) 691-2800

June 25, 2012

The 10th International Cloud Expo at the Javits Center in New York City drew over 100 firms spanning a wide array of geographies and all areas of the cloud space. Situated in a corner of the expo floor, Happtique’s booth was eyed by attendees with more than a little curiosity, as if we were the oddball in the cloud community.  Indeed, we were. But the relevance of the cloud for Happtique cannot be overstated, especially when you consider the momentum of the mHealth industry.

Two things will likely define the new age of healthcare. The first is the digitization of information. As a provision of the American Recovery and Reinvestment Act of 2009, physicians who haven’t implemented an electronic medical record (EMR) system by 2015 could see their Medicare payments cut. EMRs have the potential to improve the quality of care by, among other things, aiding physician decision-making. Perhaps more importantly, digitized health records allow providers to have access to a standardized set of information, thus enabling providers to communicate more effectively about their patients.

The second defining feature of the new age of healthcare will be enhanced data collection, bringing evidence-based medicine to the next level. As part of the 2010 Affordable Care Act, the Patient-Centered Outcomes Research Institute—a group that funds research to determine the most effective treatment options for patients, caregivers, and clinicians—has already been established. Moreover, EMRs will make consolidated healthcare data available for evaluation by data-analysis teams searching for best practices—a kind of evidence-based medicine on steroids. mHealth, Happtique’s focus, is also at the core of healthcare data consolidation. Consider connected mobile devices like the iBGStar® blood glucose monitor, which enables diabetics to test their blood glucose levels and then digitally store the results, or the Zeo® Sleep Manager™, which monitors and stores patients’ sleep patterns.

mHealth will carry the digitized healthcare revolution even further. Over 15,000 health and fitness applications already exist, with countless more in development. Four out of five physicians currently use mobile devices at work. And it is estimated that 500 million people will be using health apps by 2015. Our mRx™ pilot trials are commencing with the belief that app prescribing will bolster preventative healthcare and foster enhanced connectivity between patients and physicians.

The cloud is one avenue by which this data revolution may occur. The cloud facilitates the collection from mobile devices and secure storage of all this data and will enable the next stage of healthcare.

May 9, 2012

NEW YORK, NY – Happtique, Inc., a mobile health application store and app management solution for providers, physicians, and the patients they serve, will launch a trial of mRx™, the first program to enable physicians to prescribe mHealth apps to patients. Grounded in the belief that increased physician-to-patient services will improve compliance and health outcomes, Happtique’s patent-pending technology will enable doctors across all specialties to prescribe apps to patients.

For the program trial, Happtique is recruiting physician prescribers specializing in the treatment of heart disease, diabetes, and musculoskeletal conditions, as well as physical therapists and trainers to test the technology with health and fitness apps. Participating prescribers will receive training and access to a subset of specialty-specific apps, enabling them to integrate appropriate apps into their patients’ treatment programs. Following the training, Happtique will track both prescribing processes and patient mRx™ downloads through early summer.

To build the trial prescribing catalog, Happtique will select 5-10 apps, both connected and non-connected, in each of the designated categories on both Android and iOS platforms. Once the trial apps have been selected, participating physicians and trainers will begin prescribing the apps, depending on individual patient needs.

“Mobile app prescribing will add an entirely new dimension to my ability to care for patients,” said Steven Magid, M.D. of New York-based Hospital for Special Surgery. “In this increasingly connected and mobile world, the use of Happtique’s mRx™ will improve doctor-patient communication, patient engagement, compliance, and ultimately patients’ health.”

“App prescribing will enhance the provider/patient connection and facilitate healthy behavior changes, potentially reducing costs for providers, payers, and patients,” said Happtique CEO Ben Chodor. “mRx™ is the next evolutionary step in the field, and we are confident the provider community will agree and embrace app prescribing as a way to better engage patients in their own health and improve clinical outcomes.”

ABOUT HAPPTIQUE

Happtique is a mobile health application store and app management solution that helps healthcare providers, physicians, and patients easily integrate mHealth into treatment. It offers medical enterprises—like hospitals, continuing care facilities, and physician practices—the ability to create individually branded, secure, multi-platform application stores for staff and patient use. Happtique is a subsidiary of GNYHA Ventures, Inc., the business arm of the Greater New York Hospital Association.

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Media Contact:
Leslie Chasky
Sunshine Sachs
chasky@sunshinesachs.com / (212) 691-2800