Docket No. FDA-2011-D-0530
Draft Guidance for Industry and Food and Drug Administration Staff: Mobile Medical Applications
These comments are submitted on behalf of Fight Colorectal Cancer, a non-profit, nonpartisan advocacy organization that is committed to the fight against colon and rectal cancer. Fight Colorectal Cancer (Fight CRC) is the leading colorectal cancer advocacy organization in Washington, DC, empowering survivors to raise their voices, training advocates around the country, and educating lawmakers and pushing them for better policies. We offer support for patients, family members, and caregivers and we serve as a resource for colorectal cancer advocates, policymakers, medical professionals, and healthcare providers. Additionally, we do everything we can to increase and improve research—at all stages of development and for all stages of cancer.
Fight CRC believes in fully disclosing all potential conflicts of interest. We are working with Genomic Health to develop a mobile application for patients diagnosed with colorectal cancer. The mobile app will help patients identify questions for their doctor appointments, and help record the answers. We have received unrestricted educational grants from Genomic Health which have supported our annual conference.
Neither this company nor any of our other corporate supporters have influenced our comments on this issue.
We strongly support FDA’s efforts to regulate software products which help medical professionals define treatment for specific patients in a medical setting.
We have concerns with specific examples in Appendix A – Examples of Mobile Medical Apps. In some cases, the definitions seem to blur the distinction between apps intended for use by medical professionals in a medical setting and apps used by patients. We are concerned that this lack of clarity may have unintended consequences when it comes to FDA regulation of patient-oriented apps, or even patient-oriented websites.
Following are two specific areas of concern with language in Appendix A – Examples of Mobile Medical Apps.
“Mobile medical apps that allow the user to input patient-specific information and - using formulae or a processing algorithm - output a patient-specific result, diagnosis, or treatment recommendation that is used in clinical practice or to assist in making clinical decisions”
- “output a patient-specific result, diagnosis, or treatment recommendation that is used in clinical practice or to assist in making clinical decisions” – We are concerned that this would encompass information that was intended for a patient to serve as a discussion starting point with their physician. We believe that information intended only for patient education should not be regulated under this provision since treatment protocol would not be determined by patient-focused educational materials.
- Additionally, we feel that the “formulae/algorithm” sentence is too broad. An algorithm can use very simple criteria that have nothing to do with diagnoses or prognoses. The concern should not be the use of algorithms; the concern should be what a physician can and cannot do with an algorithm’s results.
“Apps that define disease stage or progression, and provide a prognosis of a medical condition or predict a patient’s response to treatment based on analysis of physiological, laboratory, and other data…”
- We feel that many patient-focused software products, including clinical trial searches, could potentially fall into this category.
- We feel that “and other data” is too broad and opens the possibility that the use of non-relevant data could compel the FDA to regulate an app based on the collection of demographic data or even opinion surveys.
In conclusion, we urge FDA to clarify that the intent of the regulation is to regulate apps used by medical professionals to diagnose and treat specific patients in a medical setting, and specifically rule out that the regulation is intended to regulate apps used by patients to understand their medical situation and track their questions and treatment.
Thank you for the opportunity to provide comment on this topic.