This definition suggests that a mobile medical app is inevitably a medical device from a legal perspective and, thus, is intended to be used for the same medicinal purposes as a medical device. In parallel, the German Federal Institute for Drugs and Medical Devices orientation guide on medical apps also qualifies medical apps as medical devices, referring to particular intended purposes [43]:
The connection between health apps, medical apps, digital health applications (DiGA), and digital care applications (DiPA). Can be affected by medical device regulation because of the intended use for medical purposes. ~Regulated by section 33a of volume 5 of the German Social Insurance Code and DiGAV as low-risk mobile medical devices in Germany only. *Regulated by section 40a of volume 11 of the German Social Insurance Code in Germany only.
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Most of the definitions of medical apps given by scientific papers (6/11, 55%) matched the legal regulations in the United States and the EU insofar as they listed medical purposes (if they did not, it was because the scientific descriptions were not as specific as the legal papers). Owing to this finding, the flowchart offers insights on health and medical apps based on the legal definitions in the United States and the EU. However, it does not provide insights into whether an app is legally regulated. Instead, it showcases a specific app that fits the legal definitions in the named regions. However, other countries might have different legal regulations for mobile medical apps, so this flowchart can only report on the 2 regions given as case studies. The decision tree is intended to provide a low-threshold and practical way to differentiate between health and medical apps quickly. Therefore, it can be used by scientists and developers, politicians, or users of health-related apps. Owing to the recent introduction of DiPA, a concrete regulatory framework for these apps is still missing in Germany. As such, the flowchart does not include DiPA.
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IATROGENIC caused by a physician or by treatment
IDE investigational device exemption, the license to test an unapproved new medical device
IDIOPATHIC of unknown cause
IMMUNITY defense against, protection from
IMMUNOGLOBIN a protein that makes antibodies
IMMUNOSUPPRESSIVE drug which works against the body's immune (protective) response, often used in transplantation and diseases caused by immune system malfunction
IMMUNOTHERAPY giving of drugs to help the body's immune (protective) system; usually used to destroy cancer cells
IMPAIRED FUNCTION abnormal function
IMPLANTED placed in the body
IND investigational new drug, the license to test an unapproved new drug
INDUCTION PHASE beginning phase or stage of a treatment
INDURATION hardening
INDWELLING remaining in a given location, such as a catheter
INFARCT death of tissue due to lack of blood supply
INFECTIOUS DISEASE disease that is transmitted from one person to the next
INFLAMMATION swelling that is generally painful, red, and warm
INFUSION slow injection of a substance into the body, usually into the blood by means of a catheter
INGESTION eating; taking by mouth
INTERFERON drug which acts against viruses; antiviral agent
INTERMITTENT occurring (regularly or irregularly) between two time points; repeatedly stopping, then starting again
INTERNAL within the body
INTERIOR inside of the body
INTRAMUSCULAR into the muscle; within the muscle
INTRAPERITONEAL into the abdominal cavity
INTRATHECAL into the spinal fluid
INTRAVENOUS (IV) through the vein
INTRAVESICAL in the bladder
INTUBATE the placement of a tube into the airway
INVASIVE PROCEDURE puncturing, opening, or cutting the skin
INVESTIGATIONAL NEW DRUG (IND) a new drug that has not been approved by the FDA
INVESTIGATIONAL METHOD a treatment method which has not been proven to be beneficial or has not been accepted as standard care
ISCHEMIA decreased oxygen in a tissue (usually because of decreased blood flow)
SARCOMA a type of cancer
SEDATIVE a drug to calm or make less anxious
SEMINOMA a type of testicular cancer (found in the male sex glands)
SEQUENTIALLY in a row, in order
SOMNOLENCE sleepiness
SPIROMETER an instrument to measure the amount of air taken into and exhaled from the lungs
STAGING an evaluation of the extent of the disease
STANDARD OF CARE a treatment plan that the majority of the medical community would accept as appropriate
STENOSIS narrowing of a duct, tube, or one of the blood vessels in the heart
STOMATITIS mouth sores, inflammation of the mouth
STRATIFY arrange in groups for analysis of results (e.g., stratify by age, sex, etc.)
STUPOR stunned state in which it is difficult to get a response or the attention of the subject
SUBCLAVIAN under the collarbone
SUBCUTANEOUS under the skin
SUPINE lying on the back
SUPPORTIVE CARE general medical care aimed at symptoms, not intended to improve or cureunderlying disease
SYMPTOMATIC having symptoms
SYNDROME a condition characterized by a set of symptoms
SYSTOLIC top number in blood pressure; pressure during active contraction of the heart 2351a5e196
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