August 12, 2019
Xcertia Board of Directors Approves Final Version of the 2019 Guidelines
The Xcertia Board of Directors has approved the 2019 version of the Xcertia Guidelines. Initially previewed at the Connected Health Conference 2018 and then released at HIMSS19, the draft guidelines were available for a ninety day public comment period that closed at the end of May.
Since that time the work group teams representing the major areas of concentration within the guidelines; Privacy, Security, Usability, Operability and Content took into account all public comments and updated the guidelines accordingly. Those changes have been approved by both the Xcertia Executive Committee and its Board.
“The Board’s final approval of the 2019 Xcertia Guidelines marks a key milestone for the organization. We hope the publication of these guidelines will encourage others to begin the process of bringing more order to the evaluation and selection of mHealth apps that physicians and consumers will find to be of real value in their health and wellness journeys” said Michael Hodgkins, MD, Chairman of Xcertia. The final version of the 2019 Xcertia Guidelines can be found on the website www.Xcertia.org under the Guidelines tab. Individuals and organizations interested in viewing the guidelines and incorporating them into their best practices for mHealth app selection are encouraged to do so.
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February 13, 2019
Xcertia Announces Updated Guidelines to Accelerate the Development, Adoption and Use of Safe and Effective Mobile Health Apps
Public Comment Period Open Through May 15, 2019
Orlando, Fla. – Today, Xcertia announced the initial release of its updated guidelines for mobile health applications (mHealth apps), addressing five key areas of design and development: privacy, security, operability, usability and content. The Xcertia Guidelines are now available for a public comment period through May 15, 2019. Xcertia, a non-profit organization that supports the collaborative development of industry guidelines for safe and effective mHealth apps, announced availability of the guidelines at the HIMSS Global Conference taking place in Orlando, Florida.
Xcertia work groups, addressing all five key areas of the guidelines, will be responsible for further updates, ensuring that the criteria within each section of the Xcertia Guidelines is current with the latest thinking and best practices. Work group members represent a broad mix of industry expertise and experience, including subject matter experts from Partners Connected Health, HIMSS, the Personal Connected Health Alliance, Consumer Technology Association, Medstar, Duke, the Mayo Clinic, the American Association of Diabetes Education and others.
“Our guidelines development is an iterative process and our goal is to include input and comment from key stakeholders at every step along the way,” said Xcertia Board Chair Michael Hodgkins, M.D. “Recognizing that privacy and security are paramount to overcoming concerns that are hindering the adoption and use of mHealth apps, we accelerated the release of the privacy and security guidelines in October, to gain the endorsement of our board and other key partners. We are pleased to release the guidelines, and seek additional comment on all five sections. We are grateful to our work group members for their efforts to create this important guidance for the mHealth market.”
In October 2018, Xcertia released a draft of the privacy and security sections of the guidelines for public comment. Today’s release incorporates updates to these two sections, as well as new guidelines covering operability, usability and content. The completed guidelines are expected to be released in May 2019, following the public comment period, which expires on May 15, 2019.
Interested parties are encouraged to share their comments by visiting the Xcertia website www.xcertia.org, where comments can be submitted on any or all five sections within the guidelines.
“There is a pressing need in the market to establish a framework to evaluate mobile health apps and build confidence among physicians and consumers, that apps are safe, trustworthy and important tools to help people achieve their health and wellness goals,” said Dr. Hodgkins. “Xcertia encourages stakeholders throughout the ecosystem to participate in this process and support the implementation of these guidelines in the market.”
About Xcertia: Xcertia is a joint mHealth app collaborative effort pioneered by the American Medical Association (AMA), American Heart Association (AHA), DHX Group and Healthcare Information and Management Systems Society (HIMSS). The collaboration builds on each organization’s ongoing efforts to foster safe, effective, and reputable mHealth solutions. Our combined expertise, along with a diverse membership, leverages the insights of clinicians, patients, government agencies and industry experts to help improve patient care. For more information, please visit us at xcertia.org or contact firstname.lastname@example.org.
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October 18, 2018
Xcertia Releases Latest Update of Its Privacy and Security Guidelines
In its continuing effort to bolster the adoption and use of safe and effective mHealth Apps by both clinicians and consumers, Xcertia has released its latest round of revisions to the Privacy and Security sections of the Xcertia Guidelines. The release of the Privacy and Security Guidelines is the second phase of a multi-staged, annual approach in which the guidelines will go through an iterative process that combines both subject matter expert work groups, public comment periods and stakeholder input to secure a broad representation from all interested parties.
The guidelines released today represent the work of subject matter experts from organizations like AMA, AHA, Partners HealthCare, PCHAlliance, HIMSS, Consumer Technology Association and others, drawing on a broad community of experience in the mHealth App space. “As the industry continues to deal with breaches of personal data and information, we made a decision to accelerate the release of this part of the guidelines in an attempt to address these issues” said Chuck Parker, Managing Director for Xcertia.
Beginning October 18, 2018 the Privacy and Security sections of the guidelines will be available for a forty-five (45) day public review and comment period. The guidelines can be accessed at www.xcertia.org/the-guidelines and comments can be submitted via the website. The remaining sections of the guidelines focusing on Content, Operability and Usability, along with updates to the Privacy and Security sections will be released at HIMSS19 in Orlando, Florida this coming February. Interested parties who would like to participate in the process of updating the guidelines can contact Xcertia at email@example.com.
Xcertia is a joint mHealth App collaborative effort pioneered by the American Medical Association (AMA), American Heart Association (AHA), DHX Group and Healthcare Information and Management Systems Society (HIMSS). The collaboration continues to build on each organization’s ongoing efforts to foster safe, effective, and reputable health technologies. Our combined expertise, along with a diverse membership, leverages the insights of clinicians, patients, government agencies and industry experts to improve patient care.
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August 8, 2018
Xcertia Announces Addition of Four New Board Members, Food and Drug Administration (FDA) and Office of National Coordinator for Health Information Technology (ONC) Also Join the Xcertia mHealth App Collaborative
Austin, TX – Xcertia, an industry and government collaborative that supports the unmet need for guidelines that will enhance the development of safe and effective mobile health applications (apps), is pleased to announce the addition of four new directors and two ex officio board members to Xcertia’s leadership. The new board members, representing the federal government and the fields of data science, telemedicine and nursing further increases the breadth of viewpoints and disciplines involved in Xcertia’s efforts as teams of experts are now engaged in updating the draft guidelines released in December 2017.
The new full members of the Xcertia Board of Directors are:
- Murray Aitken, Executive Director IQVIA Institute for Human Data Science
- Ann Mond Johnson, CEO American Telemedicine Association (ATA)
- William Kassler, MD, MPH, Deputy Chief Health Officer, Lead Population Health Officer, IBM Watson Health
- Karen Dunn Lopez, PhD, MPH, RN, Alliance for Nursing Informatics
The ex officio members of the Xcertia Board are:
- Bakul Patel, M.S., M.B.A, Associate Director for Digital Health, Center for Devices and Radiological Health, Food and Drug Administration (FDA)
- Andrew Gettinger, M.D, Chief Clinical Officer, Office of the National Coordinator (ONC) for Health Information Technology
With the recent launch of FDA’s Digital Health Software Precertification (Pre-Cert) Pilot Program and ONC’s instrumental part in enhancing innovation in digital health, Xcertia recognized that these two agencies would be an important voice at the collaboration’s table.
“Bakul and Andrew will be key voices to influence and support how Xcertia evolves its mHealth guidelines. They will provide their expertise and opinions towards developing best practices and design elements aimed at promoting safe, effective and trusted digital health solutions. We believe it’s a significant step forward for the market when industry and government join forces to present a unified voice and positively affect the trajectory of the mobile health app market,” said David Vinson, Founding Director and Vice Chairman of Xcertia.
“Ann Mond Johnson, CEO of the ATA, said, “We are excited to join the Xcertia Board and will work closely with our fellow members to help advance Xcertia’s mission. ATA is committed to ensuring that virtual care is broadly available and implemented to maximum effect. Working in collaboration with Xcertia helps to ensure that virtual care apps are developed and implemented within a consistent framework to the benefit of consumers, providers and technology developers alike.”
The four new Xcertia directors join a board that includes the four founding directors, each representing: American Heart Association (AHA), American Medical Association (AMA). DHX Group and the Healthcare Information and Management Systems Society (HIMSS) as well as directors from the Mayo Clinic, Accenture, Partners Connected Health, and ACT|The App Association.
About Xcertia: Xcertia is a joint mHealth app collaborative effort pioneered by the American Medical Association, American Heart Association, DHX Group and the Healthcare Information and Management Systems Society. The collaboration builds on each organization’s ongoing efforts to foster safe, effective, and trusted mHealth solutions. Our combined expertise, along with a diverse membership, leverages the insights of clinicians, patients, government agencies and industry experts to help improve patient care. For more information, please visit us at xcertia.org or contact firstname.lastname@example.org.
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Healthcare, Technology Sector Leaders Team Up on Mobile Health Solutions
CTA, Xcertia announce new partnership to address accuracy, security and usability of health devices and apps
Arlington, VA, May 7, 2018 – Today, the Consumer Technology Association (CTA) and Xcertia announced a new partnership to collaborate on mobile health (mHealth) solutions guidelines – addressing key topics such as accuracy, transparency, privacy, security, regulatory compliance, interoperability and end-user experience. The agreement will leverage CTA’s technical expertise on mHealth and Xcertia’s established and industry-developed clinical and design guidelines for mHealth apps to create a blueprint for developing and evaluating effective mobile solutions in the future.
“We’re excited to partner with Xcertia to grow our expanding portfolio of health, fitness and wellness standards and address specific challenges for mobile health solutions,” said Brian Markwalter, SVP, research and standards, CTA. “U.S. sales of health and fitness devices – including wearables, hearables and sports tech – will approach 50 million units this year. And with the subsequent increase in health data these devices provide, our work with Xcertia is a critical step in addressing the availability, transparency and reliability of that data.”
“The agreement with CTA is an important step in finally bringing some order to the mobile health app market of over 350,000-and-growing apps and the relationship between apps and the devices they interface with. By developing guidelines and standards for mHealth solutions that draw upon the unique expertise of our respective organizations, we believe that the end result will be the emergence of digital solutions with a higher level of trust and confidence for both consumers and healthcare professionals,” said Michael Hodgkins, MD, Chairman, Xcertia.
The collaboration between CTA and Xcertia represents how cross-functional organizations can come together to leverage their combined expertise in an effort to advance the potential mobile health solutions can have in healthcare. Xcertia experts began their work with CTA’s Health, Fitness and Wellness Standards Subcommittee (R6.4) at CTA’s recent Technology and Standards Spring Forum.
CTA has published a robust set of Health, Fitness and Wellness Standards, creating industry testing protocols, accuracy thresholds and data availability minimums for biometric conditions such as step counting, heart rate and sleep monitoring. For additional information about the mobile health solutions framework or CTA’s Health, Fitness and Wellness Standards effort, contact standards@CTA.tech.
Xcertia publishes annually the Xcertia Guidelines, a set of app design guidelines that help ensure accuracy, content, security and privacy within a context of appropriate user experience for application programmers and organizations looking to validate applications for use. For more information, contact email@example.com.
CTA’s latest biannual U.S. Consumer Technology Sales and Forecasts report projects the total health, fitness and sports tech market will reach sales of 49.3 million units in 2018, a four percent increase from 2017; and earn $6.4 billion, a one percent year-over-year increase.
About Consumer Technology Association:
Consumer Technology Association (CTA)TM is the trade association representing the $351 billion U.S. consumer technology industry, which supports more than 15 million U.S. jobs. More than 2,200 companies – 80 percent are small businesses and startups; others are among the world’s best known brands – enjoy the benefits of CTA membership including policy advocacy, market research, technical education, industry promotion, standards development and the fostering of business and strategic relationships. CTA also owns and produces CES® – the world’s gathering place for all who thrive on the business of consumer technologies. Profits from CES are reinvested into CTA’s industry services.
Xcertia is a joint mHealth app collaborative effort pioneered by the American Medical Association (AMA), American Heart Association (AHA), DHX Group and Healthcare Information and Management Systems Society (HIMSS). The collaboration continues to build on each organization’s ongoing efforts to foster safe, effective, and reputable health technologies. Our combined expertise, along with a diverse membership, leverages the insights of clinicians, patients, government agencies and industry experts to improve patient care. For more information, please visit us at xcertia.org.
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Xcertia Announces New Board Members
September 13, 2017
CHICAGO – Xcertia, an organization that supports the collaborative development of industry guidelines for safe and effective mobile health applications (apps), announced four newly appointed members to its Board of Directors drawn from organizations that are some of health care’s biggest movers and shakers.
The new members of the Xcertia Board of Directors include:
- Kaveh Safavi, M.D., J.D., senior managing director, health industry, Accenture
- Morgan Reed, president, ACT | The App Association
- Steve Ommen, M.D., associate dean and medical director of connected care, Mayo Clinic
- Joseph Kvedar, M.D., vice president, connected health, Partners HealthCare
The four new directors join a board that includes four directors, each representing one of Xcertia’s founding organizations: American Heart Association (AHA), American Medical Association (AMA), DHX Group and Healthcare Information and Management Systems Society (HIMSS).
The directors representing Xcertia’s founding organizations include:
- Meighan Girgus, chief marketing & programs officer, AHA
- Michael Hodgkins, M.D., chair, Xcertia, and vice president & chief medical information officer, AMA
- David Vinson, vice president, Xcertia, and founder and chairman, DHX Group
- Carla Smith, treasurer, Xcertia, and executive vice president, HIMSS
“Xcertia is fortunate to have a diverse, influential and highly motivated core group of individuals representing and guiding our collaborative effort to develop best practices aimed at promoting safe, effective and reputable mobile health apps,” said Dr. Hodgkins, chair of the Xcertia Board of Directors. “We look forward to the contributions from our new directors as Xcertia continues to grow and prepares to introduce a trusted set of guidelines for the industry.”
The eight current directors will work together on appointments to fill the remaining board seats. When fully appointed, the Xcertia Board of Directors will have 15 members.
Established in December 2016, Xcertia responds to the critical need for a comprehensive effort to develop a framework of principles to promote safe and effective mobile health apps and positively affect the trajectory of the mobile health app market. Xcertia has started the guideline development process and is focused on topics such as privacy, security, usability, content and adaptability to clinical practice with the goal of being a trustworthy resource to support consumer and clinician choice of mobile health apps.
Xcertia’s governing board is committed to broad representation from consumers, developers, payers, clinicians, academia and others with an interest in the development of guidelines for mobile health apps. To join the diverse and expanding list of member organizations, visit xcertia.org for more details.
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Below are links to articles and announcements mentioning Xcertia.