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Legal
This section outlines the specific uses for our Welldoc solutions, protects our brand identity through trademarks, and clarifies important limitations of liability through disclaimers. It provides essential information to ensure a clear understanding of our offerings.
Welldoc Indications for Use
The Welldoc® App combines the FDA cleared medical device functionality of Welldoc Diabetes and Welldoc Diabetes Rx with other non-FDA cleared products – Welldoc for Diabetes in Pregnancy and Insulin Pump Users, and Welldoc Non-Diabetes Functions.
FDA Cleared – Welldoc Diabetes and Welldoc Diabetes Rx:
Welldoc Diabetes is indicated for use by healthcare providers (HCPs) and their patients – aged 18 years and older – who have type 1 or type 2 diabetes. Welldoc Diabetes is intended to provide secure capture, storage, and transmission of blood glucose data as well as information to aid in diabetes self-management. Welldoc Diabetes analyzes and reports blood glucose test results and supports medication adherence. In addition, Welldoc Diabetes provides coaching messages (motivational, behavioral, and educational) based on real-time blood glucose values and trends. It includes software intended for use on mobile phones or personal computers in the home or in professional healthcare settings. The software also allows for entry of other diabetes-related healthcare information and provides educational information.
Welldoc Diabetes Rx adds the following prescription use only insulin management features:
- For bolus insulin users with type 1 or type 2 diabetes, Welldoc Diabetes Rx includes an insulin dose calculator* to allow patients to use their prescribed regimen to calculate a dose of bolus insulin for a given amount of carbohydrates and/or blood glucose value.
- For basal insulin users with type 2 diabetes, Welldoc Diabetes Rx includes an Insulin Adjustment Program (IAP) which calculates appropriate long-acting basal insulin doses for titrating insulin levels based on configuration by a healthcare provider. The healthcare provider must activate the IAP and configure it with patient-specific parameters.
Welldoc Diabetes and Welldoc Diabetes Rx are not intended to replace the care provided by a licensed healthcare professional, including prescriptions, diagnosis, or treatment.
*Insulin Dose Calculator may also be referred to as Insulin Calculator
Non-FDA Cleared – Welldoc for Diabetes in Pregnancy and Insulin Pump Users:
Welldoc for Diabetes in Pregnancy and Insulin Pump Users (the software) is Software as a Medical Device (SaMD) intended to be used by patients – aged 18 years and older – who have type 1, type 2 diabetes, or gestational diabetes – who are also pregnant or use an insulin pump. The software is intended to help people with diabetes manage their health in their daily environment. The software, running on a mobile phone, collects health data, promotes healthy behavior, and encourages adherence to treatment plans and self-monitoring practices as advised by a healthcare provider. The software also generates electronic reports intended for a healthcare provider. The software provides secure transfer, storage, and secondary display of data from devices such as continuous glucose monitors (CGM), blood glucose meters, blood pressure monitors, activity trackers, and weight scales as well as self-reported health information. When receiving CGM data, the software also serves as a secondary CGM alarm system, providing alerts to enable immediate awareness of conditions that may require clinical intervention. The software also performs retrospective analysis of CGM data which may be used by people with diabetes and their healthcare provider when determining therapeutic strategies. The software provides educational content to encourage behaviors which may help living well with diabetes based on guidance from healthcare professional organizations. This may include promoting healthy lifestyle choices such as getting enough sleep, eating a balanced diet, maintaining a healthy weight, and promoting physical activity.
The software is not intended to replace the care provided by a licensed healthcare professional, including prescriptions, diagnosis, or treatment nor is it intended to replace self-monitoring practices as advised by a physician. The software does not provide treatment recommendations.
Non-FDA Cleared – Welldoc Non-Diabetes Functions: Prediabetes, Hypertension, Heart Failure, Weight, and Behavioral Health
The other disease state-focused products in the Welldoc App are non-FDA-cleared wellness and educational/self-management products and DO NOT interact with Welldoc Diabetes or Welldoc Diabetes Rx functions. They are intended to help people with hypertension, heart failure, or mild mental health conditions better manage and live well. Visit www.welldoc.com for full labeling information.
Disclaimers
Guidelines
FDA-clearance
- Include an asterisk at first mention of FDA-Clearance* and place disclaimer language as a footnote
- Include an asterisk at first mention of BlueStar within the context of the Welldoc App and place disclaimer language as a footnote
Important safety information
- Include language at the bottom of all commercial facing materials
Apple and Google
- Add disclaimer with Important Safety Information when speaking to app store access
Language
FDA-clearance
- *Welldoc® Diabetes and Welldoc Diabetes Rx is an FDA-cleared medical device, intended for use by healthcare providers and their adult patients with type 1 or type 2 diabetes. For full labeling information, visit www.welldoc.com. The other Welldoc App products are non-FDA-cleared and intended to promote general wellness and education/self-management of various chronic disease states.
Important safety information
- The Welldoc® App includes Welldoc Diabetes, Welldoc Diabetes Rx, Welldoc for Diabetes in Pregnancy and Insulin Pump Users (DIP & IPU) which is Software as a Medical Device (SaMD) intended to be used by healthcare providers (HCPs) and their patients – aged 18 years and older – who have type 1 or type 2 diabetes. Welldoc Diabetes and Welldoc Diabetes Rx is intended to assist patients in managing their diabetes with guidance from their providers. Welldoc Diabetes Rx requires a prescription. Welldoc Diabetes and Welldoc Diabetes Rx should not be used by patients with gestational diabetes or patients using an insulin pump. Improper use of Welldoc Diabetes and Welldoc Diabetes Rx may result in unsafe recommendations that could result in hyperglycemia or hypoglycemia. Welldoc for DIP and IPU intended for type 1, type 2 or gestational diabetes, is not FDA-cleared and not intended to replace self-monitoring practices as advised by a physician. Visit www.welldoc.com for full labeling information.
The privacy and security of your personal information is very important to us. We protect it in accordance with the Health Insurance Portability and Accountability Act.
Apple and Google
- App Store and the Apple logo are registered trademarks of Apple Inc. Google Play and the Google Play logo are trademarks of Google LLC. All other trademarks are the property of their respective owners.
Trademarks
List of trademarks
- Welldoc®
- Welldoc® App
Trademark guidance
Use of trademark symbols with Welldoc’s trademarks
- The registered trademark symbol (®) can be used only with a federally registered trademark. The trademark symbol (™) can be used with an unregistered trademark. These trademark symbols are typically displayed in the upper-right corner immediately adjacent to the Welldoc Trademarks space permitting (e.g., Welldoc®). It is not necessary to use a trademark symbol with each use of a trademark; it is sufficient to use the appropriate symbol only the first time the trademark is used on a product, product packaging, advertisement, brochure, etc.
Guidelines for using Welldoc’s trademarks
- Always display the Welldoc Trademarks in a manner that communicates their trademark status. In addition to using the trademark symbols ® and ™ as appropriate, trademarks that are comprised of or contain words or letters should display those words in all caps or initial caps when typed unless the logo form of the word mark appears in lower-case letters, such as:
- Do not use the Welldoc Trademarks as nouns or verbs, and instead use Welldoc Trademarks as adjectives to modify a noun.
Correct: “I love using my Welldoc App to share health information with my doctor.”
Incorrect: “I Welldoc my health information to my doctor.” - Do not use the Welldoc Trademarks in plural form.
Correct: “The Welldoc features really helps me track my health.”
Incorrect: “I use Welldocs to track my health.” - Do not use the Welldoc Trademarks in the possessive form.
Correct: “The health tracking function on the Welldoc App is great”
Incorrect: “Welldoc’s health tracking function is great”
- Do not use the Welldoc Trademarks as nouns or verbs, and instead use Welldoc Trademarks as adjectives to modify a noun.
The rule against use of trademarks in a possessive from applies to use of Welldoc when used as a trademark. However, when Welldoc is used as a company name to identify the business, it is ok to use Welldoc in a possessive form (e.g., Welldoc’s award-winning apps make chronic condition self-management easier). Do not change any element of the Welldoc Trademarks through punctuation, abbreviation, alternate spelling, spacing, or other means. For example, do not display the BlueStar mark as Blue-Star or Blue Star.
If you have any questions about the use of trademarks, please reach out to Welldoc for more information.