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Statement from FDA Commissioner Scott Gottlieb, MD, on advancing new digital health policies to encourage …

Today we’re announcing three new, significant policy documents to advance the FDA’s approach to the development and proper oversight of innovative digital health tools. We know that consumers and health care providers are increasingly embracing digital health technologies to inform everyday decisions. From fitness trackers to mobile applications tracking insulin administration, these digital tools can provide consumers with a wealth of valuable health information. Further, clinical evidence demonstrates that consumers who are better informed about health make better and more efficient decisions, take steps to improve their lifestyles and their health choices, and often experience better outcomes.

Given these meaningful benefits from empowering consumers, we believe the FDA must, whenever possible, encourage the development of tools that can help people be more informed about their health.  And we recognize that our regulations play a crucial role in the efficient development of such technologies. Therefore, our approach to regulating these novel, swiftly evolving products must foster, not inhibit, innovation. Moreover, we must always lean in the direction of enhancing access to more information – not restricting information flow – given the ability of reliable information to positively impact daily life.

Over the last five years, the FDA has made great strides in adapting our policies to better align our regulatory approach to the iterative nature of digital health products. We’re finding that in some parts of our regulatory portfolio, our traditional approach to overseeing certain health care products does not easily fit the types of innovations that are being developed. In these cases, we must adapt and evolve our policies to make sure we continue to provide a gold standard for oversight, while enabling advancement of beneficial innovations and greater consumer access to technologies that can improve their health.

To this aim, this past summer, we issued the Digital Health Innovation Action Plan, which outlines our efforts to reimagine the FDA’s approach to ensuring all Americans have timely access to high-quality, safe and effective digital health products. As part of this plan, we committed to several key goals, including increasing the number and expertise of digital health staff at the FDA, launching the digital health software precertification pilot program (“Pre-Cert”) and issuing guidance to modernize our policies.

As we come to the end of 2017, I’m proud of the significant progress the FDA’s digital health team has made on the Action Plan. We launched the Pre-Cert pilot and selected nine diverse companies to participate. We also have invested in hiring additional talent for our digital health team, including announcing the Entrepreneurs in Residence program. Yet, we recognize there’s more work to do.

Today, we’re announcing three new guidances – two draft and one final – that address, in part, important provisions of the 21st Century Cures Act (“Cures Act”), that offer additional clarity about where the FDA sees its role in digital health, and importantly, where we don’t see a need for FDA involvement. We’ve taken the instructions Congress gave us under the Cures Act and are building on these provisions to make sure that we’re adopting the full spirit of the goals we were entrusted with by Congress.

The first draft guidance, “Clinical and Patient Decision Support Software,” outlines our approach to clinical decision support software (CDS). CDS has many uses, including helping providers, and ultimately patients, identify the most appropriate treatment plan for their disease or condition. For example, such software can include programs that compare patient-specific signs, symptoms or results with available clinical guidelines to recommend diagnostic tests, investigations or therapy. This type of technology has the potential to enable providers and patients to fully leverage digital tools to improve decision making. We want to encourage developers to create, adapt and expand the functionalities of their software to aid providers in diagnosing and treating old and new medical maladies.

This draft guidance is intended to make clear what types of CDS would no longer be defined as a medical device, and thus would not be regulated by the agency. For example, generally, CDS that allows for the provider to independently review the basis for the recommendations are excluded from the FDA’s regulation. This type of CDS can include software that suggests a provider order liver function tests before starting statin medication, consistent with clinical guidelines and approved drug labeling.

However, the FDA will continue to enforce oversight of software programs that are intended to process or analyze medical images, signals from in vitro diagnostic devices or patterns acquired from a processor like an electrocardiogram that use analytical functionalities to make treatment recommendations, as these remain medical devices under the Cures Act.  For example, we would continue to oversee software that analyzes data from a patient’s spinal fluid test to diagnose tuberculosis meningitis or viral meningitis. These are areas in which the information provided in the clinical decision software, if not accurate, has the potential for significant patient harm, and the FDA plays an important role in ensuring the safety and effectiveness of these products.

Similarly, the CDS draft guidance also proposes to not enforce regulatory requirements for lower-risk decision support software that’s intended to be used by patients or caregivers — known as patient decision support software (PDS) — when such software allows a patient or a caregiver to independently review the basis of the treatment recommendation. Although PDS was not part of the Cures Act, the FDA believes that PDS should follow a similar regulatory structure as CDS. An example of lower-risk PDS products could include software that reminds a patient how or when to take a prescribed drug, consistent with the drug’s labeling. PDS software that does not clearly allow independent review of the recommendation by the patient or a caregiver would continue to be subject to the FDA’s active oversight. This might include a warfarin monitoring device that makes recommendations for dosing based on the outcome of a home blood test.

We believe our proposals for regulating CDS and PDS not only fulfill the provisions of the Cures Act, but also strike the right balance between ensuring patient safety and promoting innovation.

The second draft guidance being issued today, “Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act,” addresses other digital health provisions included in the Cures Act. Specifically, this second guidance outlines the FDA’s interpretation of the types of software that are no longer considered medical devices. We’re making clear that certain digital health technologies – such as mobile apps that are intended only for maintaining or encouraging a healthy lifestyle – generally fall outside the scope of the FDA’s regulation. Such technologies tend to pose a low risk to patients, but can provide great value to consumers and the healthcare system.

Through this draft guidance, we’re proposing changes to previously published agency guidance documents, including: General Wellness and Mobile Medical Applications, among others, to be consistent with the Cures Act and reflective of the agency’s new, more modern approach to digital health products. The proposed changes include updating the categories of products for which, prior to the Cures Act, the FDA already intended to exercise enforcement discretion owing to their very low risk and potential benefits to patients from greater innovation. Now, to create an even clearer distinction, consistent with the Cures Act, we’re saying that many of these products no longer qualify as medical devices that would be subject to the FDA’s oversight.

In addition to taking steps to clarify the FDA’s position on digital health, we’re also working with our global counterparts to harmonize and streamline the regulation of digital health products internationally.

Innovations in digital health remind us that we live in an interconnected world – one that reaches across borders and joins us in new and unique ways. That’s why in recent years, we’ve worked closely with regulatory authorities across the globe through the International Medical Device Regulators Forum (IMDRF) to evaluate requirements in individual countries, and harmonize our regulatory approaches to digital health medical devices, where possible. Many of our global counterparts are represented, including Australia, Brazil, Canada, China, the European Union, Japan, Russia and Singapore. 

As part of our package of policies being announced today, the FDA also is issuing a final guidance, “Software as a Medical Device: Clinical Evaluation,” in fulfillment of these international harmonization efforts. This guidance was initially issued in draft in October 2016 and informed by global and domestic comments. Today’s final guidance expands on that draft. It establishes common principles for regulators to use in evaluating the safety, effectiveness and performance of Software as a Medical Device (SaMD). This final guidance provides globally recognized principles for analyzing and assessing SaMD, based on the overall risk of the product. The agency’s adoption of these principles provides us with an initial framework when further developing our own specific regulatory approaches and expectations for regulatory oversight, and is another important piece in our overarching policy framework for digital health.

In sum, these three important guidance documents being issued today will continue to expand our efforts to encourage innovation in the ever-changing field of digital health. Our aim is to provide more clarity on and innovative changes to our risk-based approach to digital health products so that innovators know where they stand relative to the FDA’s regulatory framework. Our interpretation of the Cures Act is creating a bright line to define those areas where we do not require premarket review. And we’re providing more detail on those technologies and applications that would no longer be classified as a medical device subject to FDA regulation. This will allow us to focus our efforts on the highest-risk products. Finally, we’re issuing new details on the common principles we and our international partners will use for evaluating the safety and effectiveness of SaMD. Through this comprehensive approach, we can deliver on our commitment of promoting beneficial innovation in this space while providing proper oversight where it’s merited.

We’ll be taking other steps to implement our Digital Health Innovation Action Plan. We’re hosting a Pre-Cert Pilot Program workshop on January 30-31, 2018  to update FDA staff, participants and stakeholders on the lessons learned from the pilot. Later in the year, we’ll share the pilot’s proof of concept and outline next steps for establishing a Pre-Certification Program. We look forward to working with patients, providers, technology developers and other customers in helping Americans access safe and innovative digital health products.


Sen. Moran questions panelists on advancing the Internet of Things in rural communities

On Nov. 7 U.S. Sen. Jerry Moran, R-KS—member of the Senate Commerce, Science, and Transportation Committee—questioned panelists during a Senate Commerce Subcommittee on Communications, Technology, Innovation and the Internet hearing entitled, “Advancing the Internet of Things in Rural America.” The hearing was convened to examine the current usage of the Internet of Things in rural America, to assess the economic and societal benefits of IoT in rural communities and to explore potential infrastructure needs.

“Making certain that more of our rural communities can utilize technologies related to the Internet of Things in their homes, classrooms and businesses is crucial to closing the digital divide,” said Sen. Moran. “I look forward to continuing this discussion next week during my subcommittee hearing on data usage practices for farms to improve interconnection among members of our rural agricultural community.”

Moran will convene a hearing Nov. 14 in his Senate Commerce Subcommittee on Consumer Protection, Product Safety, Insurance and Data Security titled “Technology in Agriculture: Data-Driven Farming.”

Watch the Nov. 7 hearing below.

Advancing The Mental Health And Well-Being Movement Through Grant Making: Engaged Philanthropy

Investing in the health of a nation requires thoughtful deliberation and vision. Grantmakers, especially those with a focus on health, play a unique role in helping support community innovation that can advance health. However, without a clear focus on what they are trying to effect, the direction they want to go with their investment, and how to accomplish their goals, how will the grant-making community ever know if it is making a difference and if it is improving health?

The United States, now more than ever, needs clear direction to create more comprehensive solutions to fragmented problems. Grantmakers play an essential role in this space and have a responsibility to further the movement currently under way to address mental health and wellness. However, without proper alignment with the community as well as other foundations, grantmakers may add to the cacophony rather than advance the movement.

Health is a state of complete physical, mental, and social well-being and is not merely the absence of disease or infirmity. Health is the foundation of achievement. In our journey to address health through policy, we have too often ignored mental health and substance use, which remain some of the most pressing health issues in our nation. Whole-person well-being requires foundations to use new clinical, financial, policy, and investment strategies that better incorporate and integrate mental health.

Mental health is a highly prevalent health need. However, people with mental health needs often do not get the care they need, and when they do not get that care, they end up costing more to society, the system, their community, and most importantly, their families. This is not to say that individuals with physical health needs always get their needs met, but more that mental health is often not addressed in larger policy and investment deliberations.

Delaying treatment when people need it most can often cause a series of unintended consequences. For example, consider that “suicide in the United States has surged to the highest levels in nearly 30 years,” with a nearly 25 percent increase just from 1999 to 2014, according to an April 2016 article in the New York Times that describes a 2016 National Center for Health Statistics study. And, to compound this problem, the United States woefully lacks the mental health workforce needed to help. And what about the opioid epidemic?

While each of these issues has its own root causes, the fact that we do not have a more responsive and comprehensive strategy is troubling.

Simply funding more programs is not the answer. More systemic solutions for these larger community problems need to be created, and our foundations can help lead the way. Health foundations can lay the groundwork to advance community innovation around mental health and wellness through their leadership, funding, and ongoing understanding of matching their investments with community need and ultimately connecting to policy that allows for scalability and sustainability.

It is within this context that a new foundation emerges to help advance mental health and well-being in collaboration with other foundation and community partners. An independent 501(c)(3) public foundation, Well Being Trust was created in 2016 by an investment from the Providence/St. Joseph Health System. A national funder, Well Being Trust is based in Oakland, California. Well Being Trust’s mission is to improve the mental, social, and spiritual health of the nation. We aim to do this through thoughtful partnerships, strategic grant making, and alignment of the two in an attempt to advance health and wellness through policy.

Aligning with the belief that language changes culture, we at Well Being Trust are progressive with our language, making it reflective of our understanding of health and wellness. For us, mental health is essential to whole health. Whole health is essential to well-being, and to accelerate the adoption of strategies that help support health and wellness, we want our language to guide our discussions in the community, our policy work, and our grant making.

Alongside many of our grantmaker colleagues, we believe that health care has become too fragmented—that those in communities who need care the most must work harder than they should to get the care they need. We also believe that health care is not the most important factor contributing to improved health and well-being. We see the role of community and of social factors as critical in achieving population health and broader well-being. This is the context in which our foundation finds its unique foothold.

Guiding Principles

To separate ourselves from other health foundations and to look for possibilities within partnerships and complementariness, we have established principles—philosophies that we will use to approach our work. We also see these as being applicable for other foundations looking to make an impact and advance mental health and wellness.

Engaged philanthropy: Created to bring together people who can tackle some of the most critical health issues our country is facing, Well Being Trust plans to serve as a funder that partners and engages with communities and leaders to advance mental health and wellness. Building upon our grant-making capacity, we will invest in community initiatives that can make a difference in people’s lives. Like many foundations, we believe that these investments should be partnerships. Further, being aware of community context and strategically connecting innovators and investors across the country with an eye to changing the culture of health (a term coined by the Robert Wood Johnson Foundation), we can make health more integrated, complete, whole, and responsive to the needs of the community. We believe, in doing this, we can help change the health of the nation—making well-being a priority.

Furthering a movement: Recognizing that no movement can be owned, Well Being Trust aims to catalyze and crystallize the innovations that are out there as it attempts to organize and advance the movement of mental health and wellness. Facilitation by a foundation can help by bringing people and organizations together to tackle some of the most critical challenges facing America, such as mental health. As we are driven to serve the poor and vulnerable, our mission when combined with this movement will have the opportunity to help transform communities, change public policy to put people first, and build a bank of hard evidence around what works to make people healthy and well. Change of this magnitude will take time and persistence, but together we can build a future where stereotypes are broken down, communities are stronger and more supportive, and hope is restored.

Have a vision: Transforming health and health care requires thoughtful partnerships and strategic investments, but most importantly, an understanding that health is whole and in need of integrating. Despite so much uncertainty around the future of health care, foundations should commit to have a vision and advance this vision by playing a leadership role in transforming the health of the nation, partnering with those who best know what they need: our communities and our grantees.

To truly advance the mental health and wellness agenda for the country, and to make this work successful, grantmakers will have to be creative with their investments. For example, recently Well Being Trust initiated a partnership with iHeartMedia to bring attention, through radio, to mental health and wellness. Partnering with media to help bring the message that mental health is essential to whole health can help expand and elevate the national dialogue on mental health and wellness. At its core, how we think, feel, and act are basic elements that contribute to our overall well-being. Using the medium of radio to bring attention to mental health and wellness can help lead to conversations in the car, café, community, and, ultimately, Congress.

As foundations like Well Being Trust launch more innovative programs around mental health and wellness, it is important that we all join up in partnerships on this journey. Today, that journey could begin with a hashtag—a hashtag that can help accelerate a national dialogue on mental health and wellness. Tomorrow, that hashtag could turn into broader change that brings a community together. Together, let us #BeWell, and together let us partner to change the health of our nation one community at a time.

Health foundations: it is time to come together and transform mental health in this country.

Related reading:

“Creating A Culture Of Whole Health: A Realistic Framework For Advancing Behavioral Health And Primary Care Together,” by Benjamin F. Miller, GrantWatch section of Health Affairs Blog, April 14, 2016.

“State Licensing And Reimbursement Barriers to Behavioral Health And Primary Care Integration: Lessons From New Jersey,” by Joan Randell and John Jacobi, GrantWatch section of Health Affairs Blog, April 7, 2016.

“Advancing Integrated Behavioral Health Care In Texas And Maine: Lessons From The Field,” by Becky Hayes Boober and Rick Ybarra, GrantWatch section of Health Affairs Blog, August 11, 2015.

“Foundations’ Roles In Transforming the Mental Health Care System,” by Lauren LeRoy, Margaret Heldring, and Elise Desjardins, GrantWatch section, July 2006 Health Affairs.


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