The Food and Drug Administration (FDA) has announced several new initiatives that reflect its ongoing commitment to maintain patient safety, while also championing the need and opportunity for health care innovation.

During opening day of Health Datapalooza, FDA Commissioner Scott Gottlieb highlighted the critical import of novel digital health tools in achieving patient-centered care, and outlined how the agency is committed to moving the ball forward in health care innovation through the following initiatives: Continue Reading FDA Advances Flexibility-Based Framework for Digital Health and AI

On March 6, 2018 at the Healthcare Information and Management Systems Society (HIMSS) 2018 conference, Centers for Medicare & Medicaid Services (CMS) Administrator Seema Verma announced a new initiative furthering the current Administration’s focus on value-based care and increasing patient access to healthcare data. The initiative — called MyHealthEData — will be led by the White House Office of American Innovation, in collaboration with the Department of Health and Human Services (HHS), CMS, the Office of the National Coordinator for Health Information Technology (ONC), the National Institutes of Health (NIH), and the Department of Veterans Affairs (VA). (CMS press release here.) Continue Reading Liberating Data to Transform Value-Based Care: MyHealthEData, Blue Button 2.0, and Price Transparency

This morning, the Food and Drug Administration released highly anticipated guidance on clinical and patient decision support that has been in the works at the agency for several years, advising the digital health community about how it plans to regulate software that offers recommendations or feedback to its users—both healthcare professionals, and patients and caregivers. It also provides guidance on FDA’s interpretation of new software provisions in Section 3060 of the 21st Century Cures Act.

Given the explosion of these innovative digital health tools and their strong potential to transform healthcare, this guidance is a significant development for tech companies and investors focusing on this space. Comments will be accepted for 60 days. Continue Reading FDA Issues New Guidance for Clinical and Patient Decision Support Software

The AMA recently adopted a set of principles on mHealth applications (mHealth apps) and other similar digital health tools, to guide coverage and payment policies and the AMA’s advocacy efforts. While many have touted the potential health benefits of mHealth apps and digital devices, the AMA also raises concerns about the potential health and safety risks that these apps can pose to patients along with privacy and security risks.

In developing a set of principles to support the use of mHealth apps and devices, the AMA has demonstrated a willingness to adapt to such innovation while restating some of its long held positions on the roles of physicians, licensure laws, and the need for evidence. Digital health tools, including mHealth apps, can challenge some of these positions. The principles are:

  • Support the establishment or continuation of a valid patient-physician relationship;
  • Have a clinical evidence base to support their use in order to ensure mHealth app safety and effectiveness;
  • Follow evidence-based practice guidelines, to the degree they are available, to ensure patient safety, quality of care and positive health outcomes;
  • Support care delivery that is patient-centered, promotes care coordination and facilitates team-based communication;
  • Support data portability and interoperability in order to promote care coordination through medical home and accountable care models;
  • Abide by state licensure laws and state medical practice laws and requirements in the state in which the patient receives services facilitated by the app;
  • Require that physicians and other health practitioners delivering services through the app be licensed in the state where the patient receives services, or be providing these services as otherwise authorized by that state’s medical board; and
  • Ensure that the delivery of any services via the app be consistent with state scope of practice laws.

It is clear that as physicians are increasingly incorporating digital health tools such as mHealth apps into their practice and advice to patients, the AMA needed to state its position on these digital health tools.  The AMA’s focus on the impact and the role of the physician is not surprising; however, it may limit the usefulness of some new tools and services.

There are two important issues that the AMA addresses: data protection and safety.  First, the AMA publication serves as an opportunity to advise physicians about new privacy and security concerns that may arise from mHealth apps.  The principles encourage physicians to alert patients of the potential privacy and security risks for any mHealth apps that they recommend and document the patient’s understanding of these risks.  The AMA also advises physicians to consult with legal counsel to ensure that mHealth apps and devices meet privacy and security laws.

Second, the AMA focuses on safety, which is a key issue that will grow in importance, safety and effectiveness.  For example, with the passage of the 21st Century Cures Act, Congress limited FDA’s authority to regulate mHealth apps and related devices.  This could leave physicians with less clarity about the safety and effectiveness of these digital health tools.  An industry-based approach to review mHealth apps may be the only way to give some clarity in this uncertain market.

We will have to wait and see what impact this position has on future policy and industry action, but the publication serves as a reminder about the importance of these issues.