Connect Health Initiative Lauds CMS Digital Health Interoperability Initiative

Las Vegas, NV - Today, CMS Administrator Seema Verma announced new proposals to promote interoperability in the digital health ecosystem that support greater patient data access. The proposals, which include a new version of the Blue Button API and stricter rules on data blocking, will bring significant benefits to innovators in the digital health ecosystem. Morgan Reed, executive director of ACT | The App Association's Connected Health Initiative (CHI) released the following statement in support response to the new proposals.

“CMS Administrator Seema Verma’s remarks reiterate CMS’ commitment to a 21st century healthcare system. We are hopeful that measures announced today lead us on a path to make that a reality. The new Blue Button 2.0 API should bring two-way capable APIs into the healthcare marketplace to be used across platforms and doctors. Additionally, access to Medicare data is critical in turning data into actionable information for doctors and healthcare providers. We have long advocated for these changes and recognize this as a huge step in the right direction. CHI applauds CMS’ intent to reexamine meaningful use and consider measures that increase interoperability and penalize data blocking activities. Our members need access to interoperable data to fuel and effectively implement their digital health solutions. We are encouraged by this cross-agency cooperation, and we look forward to working with CMS on the path forward.”


Significant FDA Regulatory Advancements Clear a Path Forward for Connected Health Innovators

More than 60 percent of Americans already use mobile apps to make informed choices about their health. In the year ahead, we expect app-enabled telehealth tools and remotely monitored patient-generated health data (PGHD) to present more promising avenues to improve care quality, reduce hospitalizations, avoid medical complications, and improve patient satisfaction, particularly for the chronically ill.

As the sole regulator of medical devices, the Food and Drug Administration (FDA) plays a vital role for connected health innovations to get into the hands of doctors, caregivers, and patients. The Connected Health Initiative (CHI) has long worked with the FDA to shape policies and regulations that support and foster medical innovations, while protecting patient safety.

In 2017, the FDA introduced new guidance and programs that will greatly influence our members’ ability to introduce new telehealth tools to market and into the doctor’s office. We will use the momentum of these new changes and regulatory advancements to continue our advocacy with the FDA in 2018.

New Draft Guidance for Clinical Decision Support Software

For years, CHI members have developed clinical decision support (CDS) tools that help doctors use data to make treatment decisions. However, silence from the FDA on whether, and how, it regulates CDS software ultimately dampened the drive to bring these care-improving, cost-saving innovations to the medical community. In fact, several of our members recalled or redesigned effective products because of the uncertainty surrounding the FDA’s regulatory approach to CDS.

The 21st Century Cures (21CC) Act includes a requirement that the FDA issue CDS software guidance—a provision that CHI recommended. Following the passage of the 21CC Act, the FDA finally released draft regulatory guidance on CDS software.

The draft guidance clarifies the necessary functions of CDS software to be considered a “device,” as amended by the 21CC Act. The guidance states that CDS software is considered a regulated medical device if it makes clinical diagnoses or treatment decisions independent of the doctor. Conversely, CDS software is not considered a regulated medical device if it enables a doctor or healthcare professional to make recommendations or independent review decisions. In other words, the FDA sees CDS software as a tool to assist physicians and their ability to make treatment decisions; if the software makes autonomous decisions, it will be regulated.

In addition to this definition, the FDA’s draft guidance offers examples to illustrate its regulatory approach to CDS software. The examples confirm that software making recommendations by combining patient-specific information with widely-available medical practice guidelines, public drug labeling information, or publicly-available information will not be regulated as medical devices. Conversely, software that independently analyzes or manipulates data, like “proprietary algorithms,” to recommend a specific treatment, without prompting the healthcare professional to review the decision, will be classified as medical devices. It is important to note that the FDA guidance reinforces the policy of enforcement discretion (i.e., absolving the need for regulation) for software that is considered a medical device but poses a low risk to patients.

The draft guidance also introduced a new category, Patient Decision Support (PDS) software, which pertains to software used by anyone not classified as a healthcare professional (such as a patient or other caregiver). This definition leaves PDS software unaffected by the 21CC Act’s section 520(o). The FDA’s approach to PDS software aligns with CDS software and uses the same “independent review of the basis of the recommendation” differentiation. The guidance also offers), offering an enforcement discretion policy for PDS software equivalent to that taken for CDS software excluded from the definition of a medical device as well as that taken for CDS that qualifies as a medical device but would enjoy enforcement discretion. Examples of PDS software that will see future FDA regulatory oversight, as well as software that will not, are included.

Public comment is sought on this draft guidance by February 6. CHI staff is currently working with its members to formulate our detailed input on this draft.


Draft Changes to Various Guidance Documents in Light of 21st Century Cures Act Changes to Medical Device Definition

The FDA has also issued draft guidance titled Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act, which proposes modifications to four key guidance documents for the connected health tech community:

Further, the FDA proposes to withdraw one existing guidance document, Guidance for the Submission of Premarket Notifications for Medical Image Management Devices.

With the 21CC Act’s passage, the FDA is proposing to revise each guidance document per the alternations made to the definition of a medical device under section 520(o)(1)(A)-(D) of the Federal Food, Drug, and Cosmetic Act. In short, the 21CC Act restricted the FDA from regulating certain kinds of software, and the FDA is now revising its relevant guidance documents accordingly.

With the passage of the 21CC Act, the definition of a medical device must now exclude:

  • Software used for admin support of a healthcare facility (including “population management”);
  • Software that encourages a healthy lifestyle (unrelated to disease prevention or treatment);
  • Software that serves as an EHR and does not interpret or analyze for purposes of prevention or treatment; and
  • Software for storing/transferring/displaying data that does not interpret or analyze for purposes of prevention or treatment.

The FDA discusses each of the above categories of software and related changes needed in various guidance documents (and proposes that its rationale will be added to the ‘Background’ section of each guidance document once finalized), particularly to the examples listed in each. Notable proposals include:

  • Reinforcement by the FDA of its commitment to continue to not enforce applicable requirements for general wellness/healthy lifestyle software functions that present a low risk to the safety of users and other persons.

  • That mobile apps intended for individuals to “log, record, track, evaluate, or make decisions or behavioral suggestions related to developing or maintaining general fitness, health or wellness” be indicated as not qualifying as medical devices.

  • That electronic health record (EHR) software certified by HHS’ Office of the National Coordinator for Health IT (ONC) and mobile apps used to access an EHR are not considered medical devices.

  • That products solely intended to “transfer, store, convert formats, and display medical device data and results, including medical images, waveforms, signals, or other clinical information” are not medical devices

Public comment is sought on this draft guidance by February 6. CHI staff is currently working with its members to formulate our detailed input on this draft.

Final Guidance on Clinical Evaluation of Software as a Medical Device (SaMD)

The FDA has also issued final guidance titled Software as a Medical Device (SaMD): Clinical Evaluation. This guidance, adopting the approach to clinical evaluation of SaMD developed within the International Medical Device Regulatory Forum, is intended to provide “a path for global regulators to converge on terminology, a risk-based framework, an understanding of quality management system principles, and…an approach to making [SaMD] clinically meaningful to users.”

This extensive IMDRF-developed document approaches SaMD clinical safety, effectiveness, and performance evaluation through a process broken down into three areas: (1) valid clinical association, (2) analytical validation, and (3) clinical validation. Further, it describes how:

  • Clinical evaluation should be “an iterative and continuous process as part of the quality management system for medical devices.”
  • Certain SaMD may need “independent review of the results of the clinical evaluation” to validate its clinical value, “commensurate with the risk posed by the specific SaMD.”
  • SaMD manufacturers/developers should employ continuous monitoring of the safety, effectiveness, and performance of SaMD to understand and modify software based on real-world performance.

FDA’s Software Precertification Program

Building on extensive collaborative work with several key stakeholder groups (including CHI) across the last few years, in mid-2017 the FDA announced a new “Software Precertification Pilot Program.” The program aims to build a new streamlined approach to its regulation of software, including a precertification program for the assessment of companies that design and test software. At the time of this announcement, the FDA stated that it intends to “develop a precertification program that could replace the need for a premarket submission in some cases and allow for decreased submission content and/or faster review of marketing applications for software products in other cases.” CHI has publicly supported the FDA’s pilot program.

In September 2017, the FDA announced that nine organizations were accepted to participate in the pilot program. The FDA later announced plans to convene a public workshop on January 30-31, 2018, at the National Institute of Health’s main campus in Bethesda, Maryland. According to a detailed agenda, the workshop’s purpose is to “discuss the progress of the pilot precertification program and to seek input on the ongoing development of the Software Precertification Program.” CHI has been invited to participate in the workshop, and we look forward to playing a role in the development of this program.


CHI is thrilled to witness the significant steps the FDA is taking to modernize its approach to software-driven innovations in the healthcare space. We strongly support the FDA’s efforts to update oversight and regulation while providing American patients with safety and confidence in their care. Paired with recent breakthroughs, driven by CHI’s efforts, towards establishing reimbursement in the Medicare system (in both the CY 2018 Physician Fee Schedule and in the latest Quality Payment Program) for caregivers that wish to use remote monitoring tools to improve patient care while reducing costs, CHI continues to see evidence of, and grow more and more optimistic about, the ability of the IoT to transform American healthcare, also providing global leadership to other key market regulators.

We encourage you to reach out to us with your interest and views on any of the above as CHI moves forward into 2018.

Recognition, Reimbursement, Results: Why 2017 Was a Win for Connected Health

As we look to the year ahead, this is an important time to reflect on 2017, and the exciting developments that will make 2018 even better for connected health innovation. 2017 was a busy and successful year for the Connected Health Initiative (CHI). We worked with the Centers for Medicare and Medicaid Services (CMS) to propose incentive and reimbursement opportunities for the use of remote monitoring tools, we urged the U.S. Food and Drug Administration (FDA) to administer much-needed guidance around the use of digital health tools and software, and we advocated for congressional efforts that support innovations in digital medicine and the protection of patients’ sensitive health data. In addition to the 17 comments filed to health agencies in the United States and the European Union, more than 40 connected health-related meetings held on the Hill, and a host of briefings and coalition meetings, CHI led several successful efforts to encourage the integration of connected health technologies throughout the American healthcare ecosystem. Here are the top five highlights for 2017.

1) CMS Introduced New Incentives to Encourage Physician Review of Patient Generated Health Data

 In February, CHI answered CMS’ call for new improvement activities under the Quality Payment Program (QPP) Merit-based Inventive Payment System (MIPS) by suggesting that the activity of reviewing patient generated health data (PGHD) be recognized under the program. By November, CMS heard our call, and made it official, by including our improvement activity in their final rulemaking. For background, CMS maintains a database of Improvement Activities that qualifying physicians can use to calculate their MIPS score at the end of each year. As the name suggests, the merit-based system allows participating physicians to accrue points upon completing a specific activity, and those points can result in a financial bonus if a certain threshold is met, or a financial penalty if the points are insufficient. The improvement activity from CHI enables doctors to earn the highest number of MIPS points when they bring PGHD into their practice for the purposes of beneficiary engagement.

This is a huge win for connected health innovators. As written, this new improvement activity is “technology agnostic,” enabling doctors to equally review data gathered from patients’ wearable device or connected health tool of their choice. What’s more, many Medicare doctors and hospitals rely on improvement activities to meet their MIPS requirements. For smaller practices with fewer than 15 physicians, this improvement activity allows doctors to accrue all of their MIPS points! (For larger practices, the activity can account for half of the required points!) This marks a huge step for digital medicine and the adoption of PGHD into the management and treatment of chronic conditions.

2) CMS Activated the Reimbursement Codes for Remote Monitoring Tools, Too

2017 also saw the “unbundling” of Medicare reimbursement code 99091. Though it may seem like a random group of numbers, 99091 refers to the Physician Fee Schedule code established to account for time spent reviewing patient generated health data. Since 2015, CHI has urged CMS to unbundle and activate this code. Not only did CMS agreed to unbundle the code, but they also have assigned a value for the time spent reviewing patient generated health data. Specifically, physicians may now be reimbursed when they spend a minimum of 30 minutes reviewing PGHD from a remote monitoring tool.

This is a big deal. Considering the $1.02 trillion spent by CMS on reimbursement last year, unbundling the 99091 code will allow pioneering physicians to be reimbursed for incorporating patient generated health data into their practice and treatment efforts. By acknowledging the value of patient generated health data, we remove a significant barrier to the uptake of remote monitoring and telehealth tools. In the year ahead, we look forward to working as part of the American Medical Association’s Digital Medicine Payment Advisory Group (DMPAG) to create additional reimbursement codes to allow doctors to be paid for a broad array of innovative telehealth solutions.

3) FDA Issued Long-Awaited Guidance on Clinical Support Software

In early December, the FDA released draft guidance on the regulatory treatment of clinical decision support (CDS) software and its role within the FDA risk framework. Since 2011, CHI has urged the FDA to provide greater clarity in the regulatory requirements for medical grade software. The draft guidance finally makes clear that the FDA will place their regulatory focus on the safety and effectiveness of software that independently analyzes patient data, rather than on software that facilitates physicians’ ability to use data to make treatment decisions. This nuanced guidance will help create a clearer landscape for the current and future developers of clinical decision support software.

This is important because, after years of engagement, our advocacy is beginning to pay off. Since our inception, CHI has worked with the FDA in a variety of ways, including educating staff on the potential of digital medicine for patients and physicians, providing technical overviews of CDS software, and exploring how to improve the relationship between physicians and technology. We will continue these efforts in the year ahead.

4) CHI Collaborated with Health and Human Services (HHS) to Create Opportunities for Remote Monitoring

In May, CHI sent a letter to HHS leadership outlining the ways the agency could better support the adoption of digital medicine. In particular, the letter called on HHS to use their authority to waive payment and program requirements to allow remote monitoring tools to be used in treatment.

Throughout the year, HHS used our letter to guide several internal actions related to remote monitoring. Significantly, they heeded our call to waive the telehealth restrictions within 1834(m) of the Social Security Act to allow for reimbursement of remote monitoring activities within the 2018 Physician Fee Schedule. We’re honored that HHS took our advice to create opportunities for increased use of remote monitoring tools, and we look forward to covering more ground with the agency in 2018.

5) The CHRONIC Care Act Gained Traction on the Hill

Ever since the Creating High-Quality Results and Outcomes Necessary to Improve Chronic (CHRONIC) Care Act was introduced in Congress in April, CHI has been a vocal supporter. The bill looks to improve care options for patients with chronic conditions, particularly those aged 65 and older. The bill looks to expand telehealth offerings for this community to allow patients on dialysis, at risk of stroke or on specific insurance plans to receive at-home telehealth treatment and assessment, regardless of their geographic location.

In the months following the bill’s introduction, CHI signed and sent several letters in support, and our advocacy paid dividends. With a chorus of supportive voices from throughout the connected health ecosystem, the Senate passed the CHRONIC Care Act in October. The House has also agreed to adopt the bill, and we hope they will vote on it in early 2018.


We have a lot of exciting work to continue in 2018. We will continue to work with Congress to pass legislation that removes barriers to the use of connected health solutions.  In the regulatory sphere, we will maintain an open dialogue with the FDA to ensure their guidance protects the safety, effectiveness, and availability of clinical software. Specifically, we plan to submit comments on the draft CDS software guidance and participate in the Pre-Certification Pilot workshop within the FDA’s Digital Health Innovation Action plan to continue our efforts to create a supportive regulatory environment for connected health innovators. And we will continue to collaborate with CMS to develop reimbursement codes and opportunities for remote monitoring solutions while engaging with our members and connected health innovators as they create secure, interoperable, and life-saving solutions for doctors and patients across the country.


Connected Health Initiative Sees Positive Movement in FDA Guidance

This morning, the United States Food and Drug Administration (FDA) released new guidance to provide greater clarity in the regulation and adoption of medical-grade software and digital health innovations. Under the direction of the 21st Century Cures Act, the three new pieces of guidance target the role and regulation of software, dependent on their specific use and beneficiaries. Morgan Reed, executive director of ACT | The App Association’s Connected Health Initiative, released the following statement in response to the FDA’s announcement.

“Today, the FDA finally released guidance on clinical decision support software. This long sought-after guidance is an important first step, and recognizes the many ways software can help physicians make meaningful decisions about patients’ health and treatment options. We look forward to analyzing the specifics in the guidance, and seeing how we can better support our members in developing live-saving software.

“For years, our members have developed clinical and patient decision support software, but their solutions will not be adopted, nor their benefits felt, absent a clear regulatory framework. Today’s guidance focuses regulatory intent on the safety and effectiveness of software that independently analyzes patient data, rather than on software that supports doctors’ ability to use data to make treatment decisions. We certainly expect new questions to arise as innovative software is introduced, but this marks an important beginning in recognizing the utility of decision support software as a supplemental tool in the continuum of care.”

On the FDA’s changes to Mobile Medical Applications (MMA) guidance, Reed noted:

“We have long been strong supporters of the FDA’s risk pyramid framework that was part of the September 2013 MMA guidance. We are pleased to see the FDA move additional categories of applications into the “unregulated” space as they pose no significant patient risk. In light of the increasing number of health and wellness products, the FDA’s decision to reduce regulation will support greater innovation and impact.

“In the year ahead, we look forward to participating in Pre-Certification Pilot workshop as part of the Digital Health Innovation Action Plan. This dialogue is a vital opportunity to inform FDA regulators and staff about new changes in software development models to help create a more iterative and reactive regulatory process—to the benefit of doctors, patients, and innovators alike.”


Recognition, Reimbursement, Results: Opportunities Ahead for Remote Monitoring and Connected Health Innovations

On December 4, the Connected Health Initiative and Politico welcomed the American Medical Association's Director of Physician Payment Policy Sherry Smith, University of Mississippi Medical Center, Center for Telehealth Executive Director Michael Adcock, and Podimetrics CEO Jon Bloom, MD to discuss new incentive and reimbursement opportunities for connected health innovations.

Join the conversation below.

To learn more about why reimbursement is key to the future of connected health innovation, please read Morgan Reed's most recent Medium blog "Slaying Silicon Valley’s White Whale: Realizing the Benefits of Connected Health Innovation"

Connected Health Initiative Congratulates the University of Mississippi Medical Center for Recognition as a Telehealth Center of Excellence

“We commend the UMMC Center for Telehealth for this well-deserved recognition. For more than a decade, the Center for Telehealth has been serving remote and underserved communities with their forward-thinking approach to telehealth. Telehealth solutions are not only vital to the treatment of chronic illnesses, but they also provide innovative means to improve patient outcomes and lower medical costs. We hope UMMC’s award serves as a signal for medical centers across the country to use telehealth to bring effective, low cost, high result healthcare solutions to the Americans who need them most.”

Connected Health Initiative (CHI) Check-In – Halfway Through 2017!

2017 has been a busy year for the Connected Health Initiative (CHI). As we reflect on the first half of the year, we’ve pulled together highlights of what we have done, and what lies ahead in our mission to foster a robust connected health ecosystem. No post could fully encapsulate all the work that we do, but below we provide a broad outline of our work and accomplishments this year.

MACRA: Medicare’s Opportunity to Finally Embrace Connected Health Technology

The nation’s healthcare system is in the middle of a major transition – one that, if done well, will have an incredible impact on the lives of millions Americans who rely on Medicare.

The $900 billion federal program provides health insurance for Americans over 65 and others who suffer from certain conditions and diseases. For a long time, Medicare has had a reputation for being bureaucratic, lethargic, wasteful, and outdated.

Further, the Center for Medicare and Medicaid Services (CMS), which administers Medicare, has been slow to incorporate advances in advanced health technology in the program. In 2014, the agency allocated barely 2 percent of its nearly $1 billion Medicare budget to support telehealth.

CHI Launches New Tool to Help Health Tech Entrepreneurs Navigate HIPAA

Everything about the Health Insurance Portability and Accountability Act of 1996 (HIPAA), even its name, seems unwieldy and complex, especially for health tech startups. First time health tech entrepreneurs usually begin rethinking their life choices after we start discussing "covered entities" and "business associates," but in reality you can comply with the law relatively easily once you know the rules. That's why we built the HIPAA Check tool to help health tech entrepreneurs understand whether they need to comply with HIPAA and, if so, how to comply.