mHealth Policy| Mobile Healthcare Technology Regulations

Tenzing Group looks to help mHealth companies face the FDA gauntlet May 21, 2013 |

Eric Wicklund

The California-based advisory firm advises developers of mobile medical apps and their investors on how they fit under the FDA's still-unclear regulatory umbrella. More

WLSA gears up for 8th Annual Convergence Summit May 20, 2013 |

Eric Wicklund

The three-day conference, taking place May 28-30 in San Diego, aims to separate the old-style thinking of healthcare from the brash, new, disruptive world of connected health. More

Study gives YouTube the edge over other social media channels May 15, 2013 |

Diana Manos

The new report, issued by Ideahaus, indicates healthcare communications professionals are shaping their communications policies despite a lack of guidance from the FDA on the use of social media. More

Mobility: Key to overcoming barriers to clinical transformation and ACOs May 14, 2013 |

Matt Patterson

Matt Patterson, AirStrip's senior vice president of business transformation, discusses the advantages that mobility offers in transitioning to an accountable care setting. More

DocbookMD, Medweb unveil secure messaging platform for physicians May 13, 2013 |

Eric Wicklund

Unveiled at the ATA conference in Austin, Texas, Docbook Gateway offers clinicians a HIPAA-compliant platform to communicate and share images, x-rays and other reports. More

Reducing risk: Why the lack of a wireless healthcare strategy is not an option May 13, 2013 |

Eric B. Abbott

In this contributed commentary, Eric B. Abbott of ExteNet Systems lays out the four steps to establishing an effective wireless strategy in a healthcare setting. More

Tuckson tells the ATA to keep being disruptive May 10, 2013 |

Eric Wicklund

The former UnitedHealth executive helps close out the 18th Annual International Meeting & Exhibition with a call for meaningful innovation. More

Why not MU for telemedicine? May 10, 2013 |

Bernie Monegain

Ryan Spaulding, director of telemedicine and telehealth at the University of Kansas Medical Center, calls for meaningful use, a national coordinator, standards and quality measures during a presentation at the ATA's annual meeting. More

UPMC doc states his case for ROI in telemedicine May 7, 2013 |

Mike Miliard

In a session at the ATA's 18th Annual International Meeting & Trade Show, Andrew Watson examines the value derived from UPMC's programs to show 'how one model can work for telemedicine.' More

ATA breakfast panel takes a look at connected care - and 'Super Docs' May 7, 2013 |

Eric Wicklund

A Monday morning discussion hosted by Healthcare IT News at the ATA's 18th Annual International Meeting & Trade Show touts the benefits of telemedicine in four of the nation's largest healthcare networks. More

ATA kicks off its annual meeting with a call for Mercy May 6, 2013 |

Mike Miliard

The American Telemedicine Association highlights the Missouri-based healthcare network in Sunday's opening plenary to kick off the 18th Annual International Meeting and Trade Show. More

Continua Alliance launches presence in Latin America May 3, 2013 |

Eric Wicklund

The Oregon-based standards group, now established in Europe and several other emerging nations, has unveiled a Brazil Work Group to bring plug-and-play connectivity guidelines to South and Central America. More

A call for patience May 22, 2013 |

Eric Wicklund

As the mHealth world anxiously awaits the U.S. Food and Drug Administration's final ruling on how it will regulate mobile medical apps, a new blog from Kaiser Health News shows just how important that ruling will be --and may shed some light on why it's been slow in coming. More

Is design important in healthcare? May 21, 2013 |

Joseph C. Kvedar, MD

I've been in the healthcare delivery business now for 30 years and I can confidently say we've paid almost no attention to design. Systems are built around physicians' desires and workflows, and physicians tend to be quantitative, content-focused and able to handle multiple variables at once. More

Advancements abound in mHealth, but what about the pace of policy? May 20, 2013 |

Lee Kim, Esq.

Advancements in mHealth but what about the pace of policy? More

Let’s play word association: I say 'mobile,' you say … May 20, 2013 |

David Collins

I recently watched the latest 007 flic, "Sky Fall", in which Bond "comes back to life" after being killed by one of his fellow operatives. However, Bond stays out of pocket for quite some time "enjoying" his assumed death. More

A diabetes prevention coalition meets in NYC - will mHealth be on the agenda? May 15, 2013 |

Eric Wicklund

Like any chronic condition, diabetes is a disease that must be managed continuously - not just when you're visiting with your endocrinologist or doctor. A care management plan, therefore, must involve family members, other caregivers, schools and employers. More

Innovation in telemedicine: An entrepreneur's perspective May 7, 2013 |

Yulun Wang

The need to provide high-quality healthcare to everyone while reducing costs has reached a crisis level, where it's a major focus of the highest government offices. More and more politicians and healthcare leaders are realizing that telemedicine is clearly a cornerstone of the solution. This is tangibly seen by the increasing number of healthcare systems that are adopting telemedicine, by the growth of ATA and by industry investments in telemedicine products and services. More

The year ahead for the ATA and telemedicine May 7, 2013 |

Edward M. Brown

Telemedicine as we know it has been around for almost 50 years. It has moved from humble beginnings as an experimental curiosity delivering rural healthcare to become something on track for mainstream acceptance across the healthcare system. More

5 questions about mobile heath (mHealth) and defining what it is. April 26, 2013 |

Jonathan Levoy

With the emergence of mHealth, telehealth has become a sub-category inside the definition of mHealth. More

Remote patient monitoring will lead value-based healthcare April 25, 2013 |

David Lee Scher, MD

Traditional health insurance reimbursement to providers (though "payment" is a more appropriate word) for healthcare services and products is at the root of our healthcare crisis. More

Mobile Shmobile April 18, 2013 |

Matthew Grob

Mobile health is hot. It's innovative. It's impactful. It matters. But it isn't everything. More

Marrying the BYOD phenomenon to HIPAA compliance April 15, 2013 |

Lindy Benton

In today's mobile-friendly culture, few people think twice before pulling out their phone or tablet to take a picture. Recently, this cultural affinity for mobile technology has appeared in healthcare settings through the form of 'Bring Your Own Device' (BYOD) initiatives, which allow employees to use their personal smartphones and tablets to connect to a hospital's network. In fact, the Ponemon Institute reports 81 percent of healthcare providers have adopted some form of a BYOD policy. More

Remote patient monitoring, part 3: The ideal RPM system April 1, 2013 |

David Lee Scher, MD

Remote patient monitoring may serve patients who are in the post-acute care phase of recovery from a hospitalization as well as those with chronic diseases. More

mHealth Summit 2011 - Policy Track // mHealth: A Status Update and View of the Future Across U.S. Government Entities April 2, 2012 |

Foundation for NIH

Officials from the FDA, CMS, FCC and HRSA will recap federal activities related to mHealth and provide a look at policy priorities for the year ahead. Learn about where we are now and where innovation is likely to take us. More

mHealth Summit 2011 - Policy Track // Open Standards for mHealth Interoperability in Severely Resource-Constrained Environments April 2, 2012 |

Foundation for NIH

Many of the world’s funders of mHealth programs are interested in seeing international standards adopted by tools providers in order to expand the reach of programs they are currently supporting. To identify and decide on the appropriate standards is one of the key focus areas for the funders and implementers of national scale mHealth deployments. NetHope is undertaking a study for PEPFAR on this topic and they are interested in using the findings to initiate a broader discussion with industry stakeholders. Preliminary documentation will be published on HealthUnbound.org for review prior to this panel discussion. More

mHealth Summit 2011 - Policy Track // Interoperability: Overcoming the Challenges of Silos in Medical Device Development April 2, 2012 |

Foundation for NIH

Experts will discuss what it means to be interoperable and how we get there. Join the debate on what the private sector should be doing and what role government should play. More

mHealth Summit 2011 - Policy Track // Medical Grade Wireless Testing: Accelerating Deployment in Healthcare Settings through Test Environments April 2, 2012 |

Foundation for NIH

Test beds play a promising role in advancing wireless innovation. To be successful, supportive policies and coordinated activity are needed across the private sector and government. Help shape the path forward. More

mHealth Summit 2011 - Policy Track // Mapping Mobile Health Regulatory Experiences for Small and Large Companies April 2, 2012 |

Foundation for NIH

What you need to know about navigating the FDA and CMS. Learn how companies are advancing efforts to reimburse for mHealth solutions and working with the FDA on product clearance. More

mHealth Summit 2011 - Policy Track // Global Regulatory Frameworks: Understanding Regulatory Concerns Across Different Markets April 2, 2012 |

Foundation for NIH

Officials from around the globe will discuss policy initiatives in their respective countries related to mHealth. Gain better insight into markets where your company currently operates or plans to conduct business. More

mHealth Summit 2011 - Policy Track // Government Role in Scaling mHealth: Collaborations to Launch National mHealth Strategies April 2, 2012 |

Foundation for NIH

Case studies of national strategies and strategic partnerships to roll out mHealth. Learn how South Africa and Ethiopia brought together government, private and non-profit sectors to implement mHealth. More

mHealth Summit 2011 - Policy Track // The Role of Standards in mHealth April 2, 2012 |

Foundation for NIH

Experts will explore the complex standards arena, focusing on current gaps, collaborations across standards entities and implications for industry. Weigh in on how governments should use standards – from playing a role in FDA approval processes to incorporating the work of the International Standards Organization (ISO). More

mHealth Summit 2011 - Policy Track // mHealth 101: Overview of Regulatory Bodies April 2, 2012 |

Foundation for NIH

Representatives from agencies relevant to mHealth will provide a tutorial of their basic activities. Learn what innovators, investors, developers, etc. need to know about the FDA, CMS and FCC. More

mHealth Summit 2011 - Policy Track // Privacy and Security Implications of mHealth April 2, 2012 |

Foundation for NIH

Experts share the latest government thinking on privacy and security related to mHealth. Learn how we can strike the right balance between individual protections and mHealth promotion. More

Startup Elements // HIPAA Compliance March 27, 2012 |

Rock Health

Join HIPAA legal expert Stefano Quintini of Fenwick & West for everything you’ve ever wanted to know (but didn’t ask) about HIPAA. More

Startup Elements // The Entrepreneur & the FDA March 27, 2012 |

Rock Health

Bob Kocher, partner at Venrock Capital and former Special Assistant to the President for Healthcare and Economic Policy, shares everything entrepreneurs need to know about the FDA. More

Beyond the EHR: Seamlessly Connecting Nurses and Physicians Using an EHR-Extender (EHR-e) January 2, 2013 |

mHIMSS

This white paper focuses on how an EHR-Extender (EHR-e) can help hospitals leverage data trapped in the EHR and other clinical systems to establish better care team communication. The result of contextual critical alerts and texts are improved communication and enhanced workflows which makes patients, healthcare staff, administration, and regulators happy. More

Unified Communications and Surveillance in the Clinical Setting October 1, 2012 |

mHIMSS

For the modern healthcare delivery model to operate efficiently there is an undeniable mandate for seamless, comprehensive and real-time communications across the continuum of care. In this paper we will look at the link and need for collaboration and clinical information amongst various stakeholders from acute care hospitals, primary care physicians, long-term and sub-acute care providers, and to patient’s family care providers to ensure they receive the right care at the right time. More

Coordinating Care Across The Healthcare Continuum: The Value and Importance of a Connected Healthcare Platform September 20, 2012 |

mHIMSS

Healthcare delivery in the US is undergoing massive changes and while much of the discussion has centered around how best to reach National goals on quality, safety and clinical efficiency, one thing is clear. The vast amount of data elements from multiple and disparate clinical sources is compounded when patients receive care from multiple providers and the ability to provide comprehensive and real-time patient clinical information to every healthcare provider is an essential requirement to reduce costs and provide better care process. More

The 5 Rights of Clinical Decision Support: Mobile Platforms Succeed Where EM/HRs Fail September 20, 2012 |

mHIMSS

Since the first electronic medical record(EM/HR) was proposed nearly 5 decades ago, the importance of integrating pertinent clinical data focused upon relevant patient information has become increasingly important. Recognizing that when this first EM/HR was developed desktop PCs were not available, the internet was not even being considered and mobile real-time data access was science fiction, the advances we see being placed on data and the importance of structuring this into meaningful information are becoming the driving force behind healthcare informatics. More

The iEverything Enterprise: Understanding and Addressing IT's Dilemma in a World Dominated by Wireless Smart Device April 2, 2012 |

Aerohive Networks

Virtualization, cloud computing, and wireless technology are fundamentally changing enterprise computing, providing revolutionary gains in productivity and cost savings. Powerful enterprise applications can now be delivered to almost any device, anywhere, at any time. More

Branch on Demand for Healthcare: Extending and Securing Access Across Caregiving Locations April 2, 2012 |

Aerohive Networks

Healthcare professionals need to focus on quality of patient care and on securing the patient data, even in the most remote locations. Network services provided to remote facilities, clinics, and offices depend less on the size of the location and more on the functions being performed at that location. Aerohive provides Branch on Demand a cloud-enabled networking solution for remote locations that simplifies provisioning, management, security, and troubleshooting for these deployments. More

Toward an mHealth Ecosystem: Extending Access, Remote Connectivity and Engagement January 9, 2012 |

mHIMSS

According to the CDC and NIH, over 50 percent of the factors related to personal health can be traced to lifestyle choices, while only 10 percent is related to the medical care system. This finding illustrates a stark truth: the US healthcare system in its current incarnation, a system of facility based, episodic care, is insufficient to the task of improving population health. More

Enabling Collaborative Healthcare Delivery: Care Coordination Strategies with 21st Century Technology December 15, 2011 |

Intel

This paper, based on a roundtable session featuring John Mattison of Kaiser Permanente, identifies the building blocks of care coordination and the innovative technologies being deployed to support continuity of care by visionary health systems and the healthcare IT vendor community. More

Where Information and Care Meet: Secure Mobile Healthcare Solutions that Drive Care Coordination December 15, 2011 |

Intel

This paper, based on a roundtable session featuring Liz Johnson of Tenet Healthcare Corp., examines how leading hospitals and health systems in the country are implementing mobile point of care, sharing best practices and lessons learned, to deliver real-time, high-quality care anywhere. More

The Healthcare IT Innovation Imperative: Harnessing the Power of Technology for 21st Century Care Models December 15, 2011 |

Intel

This paper, based on a roundtable session moderated by Eric Dishman, highlights how the private and public sectors in the U.S. and Europe are unleashing the power of data in innovative ways to improve the quality of care while making the system more efficient and cost-effective. More

Policy and regulation for Innovation in Mobile Health December 1, 2011 |

GSMA

mHealth provides many opportunities for changing lives, and there is many considerations in terms of policies, regulation, and innovation, read one of GSMA Development Fund & PA Consulting’s whitepapers on this topic and join them in Cape Town on May 29 – June 1st www.mobilehealthsummit.org More

Providing Wireless Technology for Healthcare Transformation November 29, 2011 |

Verizon

The U.S. healthcare industry is undergoing a game-changing transformation in the way it delivers care. The “meaningful use” requirements under the HITECH Act, the new payment and delivery reform model under the PPACA and the consumer movement are all converging to help create a system that improves the quality of care and clinical outcomes, drives workflow efficiencies, and reduces and manages cost. Forward-thinking healthcare providers, payers and suppliers are taking up the challenge and looking to health IT to enable the new delivery system. Healthcare stakeholders are embracing mobility technology as a viable solution. More

mHIMSS Case Study: The Children's Hospital of Philadelphia February 26, 2013 |

mHIMSS

The key findings are focused on current and future projects which integrate mobile and wireless devices into the care delivery setting.The framework provided is based on the mHIMSS Roadmap which highlights six key areas of focus. More

June 4th @ 1PM ET -- Standalone Universal Viewing Platform: A practical and affordable approach to image enabling the EMR May 15, 2013 |

mHIMSS

Accessing a patient’s complete longitudinal medical record is frequently a cumbersome process that frustrates physicians and diminishes quality of care. The inclusion of the patient’s medical images in that record is complicated by an absence of interfaces to the various data repositories and the lack of a single multi-modality viewing application. The recent explosion of Electronic Medical Record system deployments suggests that most healthcare organizations are preparing themselves to meet Meaningful Use mandates, but a sound strategy for image-enabling the EMR remains elusive. Join us to review the many issues associated with image-enabling the EMR and see how an advanced image viewing technology can meet the numerous technical challenges as well as satisfy the physician’s performance expectations. More

Next Generation Messaging and Collaboration Strategies for Smartphones and Tablets April 4, 2013 |

mHIMSS

Physicians and nurses are increasingly using mobile devices to communicate and collaborate with their team members, the need for a secure, integrated and enterprise-wide platform that handles all form of communications – text messages, calls, alerts & tasks is crucial for patient care coordination. More

FDA Regulations on Medical Data Systems February 14, 2012 |

mHIMSS

mHIMSS Workgroup members Lee Kim (@lee_kim) and Dr. Mohamd Arif Ali (@mhealth1) presented on February 10th, 2011. The webinar provides a perspective from the clinical provider side (Dr. Ali’s perspective) and the enforcement perspective (Lee Kim’s role as an attorney). The presentation is recorded and available to members with full HIMSS access. More

Video Presentations from The 2011 mHealth Summit, December 5 - 7 2011 January 18, 2012 |

mHIMSS

This webpage hosts all of the video presentations from the The 2011 mHealth Summit, December 5 - 7 2011. More

George Washington University Course: Innovations in Telemedicine and mHealth April 2, 2013 |

mHIMSS

Advances in wireless broadband networks, almost ubiquitous mobile phone penetration, and data compression technologies are providing new avenues for radical change in the way doctors practice medicine and patients access care. More

Priority Countries and Sectors for U.S. Health IT Exports April 2, 2012 |

mHIMSS

Matthew Hein, International Trade Specialist, Department of Commerce presents on Priority Countries and Sectors for U.S. Health IT Exports. Included in the US federal government’s focus for potential export is Health Information Technology i.e. Electronic Health Records and mHealth technologies. More

Government Information Security Reform Act (GISRA) March 23, 2012 |

mHIMSS

The Government Information Security Reform Act (GISRA) requires federals agencies to implemen sound security management practices, Conduct internal as well as independent (IG) reviews of their security and Office of Management and Budget as part of the budget process (OMB will report to Congress) More

Tag you're it! You Just Became a FDA Regulated Manufacturer of Medical Device - Effect of new FDA regulations covering MDDS on Healthcare Providers November 17, 2011 |

mHIMSS

HIMSS Medical Devices & Patient Safety TF and CE-IT Community are offering an On Demand webinar that provides illustrations of what qualifies as an MDDS, FDA Requirements for MDDS manufacturers, overview of major implications for healthcare providers, timetable for compliance, what you need to know, patient safety implications, cost implications, and resources. More

Featured

Summary and Analysis of the Mobile Medical Applications Draft Guidance from FDA

mHIMSS

The mHIMSS Policy and Regulatory Implications Workgroup is pleased to present this summary and Analysis of the Mobile Medical Applications Draft Guidance for Industry and Food and Drug Administration (FDA) Staff. For those developing a mobile policy, summaries regarding OCR’s HIPAA and CMS/ONC/NIST’s Meaningful Use will be particularly insightful. Additionally, the group published material related to developers and manufacturers, and includes insights from the FTC, FCC, and FDA’s Mobile Medical App Guidelines available on the www.mHIMSS.org website. More

Meaningful Use, Stage 2 - Medicare and Medicaid Programs; Electronic Health Record Incentive Program--Stage 2

CMS, (Centers for Medicare and Medicaid Services)

HHS (US Dept. of Health and Human Services)

This final rule specifies the Stage 2 criteria that eligible professionals (EPs), eligible hospitals, and critical access hospitals (CAHs) must meet in order to qualify for Medicare and/or Medicaid electronic health record (EHR) incentive payments. In addition, it specifies payment adjustments under Medicare for covered professional services and hospital services provided by EPs, eligible hospitals, and CAHs failing to demonstrate meaningful use of certified EHR technology (CEHRT) and other program participation requirements. This final rule revises certain Stage 1 criteria, as finalized in the July 28, 2010 final rule, as well as criteria that apply regardless of Stage. More

Meaningful Use, Stage 2 - Health Information Technology: Standards, Implementation Specifications, and Certification Criteria for Electronic Health Record Technology, 2014 Edition; Revisions to the Permanent Certification Program

ONC

With this final rule, the Secretary of Health and Human Services adopts certification criteria that establish the technical capabilities and specify the related standards and implementation specifications that Certified Electronic Health Record (EHR) Technology will need to include to, at a minimum, support the achievement of meaningful use by eligible professionals, eligible hospitals, and critical access hospitals under the Medicare and Medicaid EHR Incentive Programs beginning with the EHR reporting periods in fiscal year and calendar year 2014. This final rule also makes changes to the permanent certification program for health information technology, including changing the program’s name to the ONC HIT Certification Program. More

Definitions of mHealth

mHIMSS

A collection of mHealth definitions from key healthcare organizations. More

The mHIMSS International Ecosystem Map May 20, 2013 |

mHIMSS

More

Survey: Attitudes towards Apps in Healthcare April 14, 2013 |

mHIMSS

The University of Delaware is collaborating with HIMSS Analytics and mHIMSS to assess provider attitudes towards applications “Apps” in healthcare settings. More

Policy Brief: National Broadband Plan (Chapter 10) April 2, 2013 |

mHIMSS

In 2009 the Federal Communications Commission (FCC) started work on a National Broadband Plan to create a national strategy to ensure “access to broadband capability”. More

Policy Brief: APPS Act March 14, 2013 |

mHIMSS

The Application Privacy, Protection, and Security Act (APPS Act) was introduced in a discussion draft form to the 113th congress by Congressman Hank Johnson (D-GA) on January 16th, 2013. This act, which continued themes from similar recently introduced legislation, would require application developers for various mobile devices to maintain privacy policies, obtain consent from consumers prior to collecting data, and securely maintain the data that they collect. More

Policy Brief: Mobile Device Privacy Act October 15, 2012 |

mHIMSS

Legislation introduced in the 112th Congress aims to improve mobile device security for consumers. This policy brief highlights the potential impacts on mHealth. More

Policy Brief: SET Act October 2, 2012 |

mHIMSS

The Safe, Efficient, and Transparent Medical Device Approval Act was introduced in the Senate by Senator John McCain (R-AZ) and Bob Casey (D-PA) on February 1, 2012 during the 112th Congress. More

HIMSS Vantage Point Survey: Mobile Medical Applications September 10, 2012 |

mHIMSS

On July 19, the FDA released a set of proposed guidelines on the regulation of certain mobile medical applications. Under the draft regulations, only a small number of the apps available on the market would be covered by the draft guidelines. At present, the FDA is seeking to regulate only apps that meet certain criteria. More

HIMSS response to Draft Guidance for Industry and Food and Drug Administration Staff - Mobile Medical Applications July 27, 2012 |

mHIMSS

HIMSS’s Comments on the Draft Guidance for Industry and Food and Drug Administration Staff - Mobile Medical Applications published in the Federal Register by the Department of Health and Human Services (HHS) Food and Drug Administration on July 21, 2011. More