Mobile Medical Image Analysis – Part Two

Medical imaging technology helps patients and physicians in many different ways such as helping doctors make a more accurate and timely diagnosis. Medical imaging software is also being used to monitor and treat patients. The Federal Drug Administration regulates medical devices and may regulate medical software depending on the purpose of the software and other factors.

In part one of our discussion, we reviewed some of the current applications in specific medical practices such as cardiology and some compliance issues such as the Health Insurance Portability and Accountability Act (HIPAA). In the second part of our discussion, we review in more detail the role of the FDA in the regulation of medical imaging analysis software – whether it’s used as part of a mobile application, laboratory analysis, or for other medical reasons.

What is the role of the FDA’s Division of Imaging, Diagnostics, and Software?

The Division of Imaging, Diagnostics, and Software Reliability (DIDSR) is a department  within The FDA’s Center for Devices and Radiological Health Office of Science and Engineering Laboratories (OSEL).

Some of the focal points of the division include:

• Medical imaging and diagnostics
• Artificial intelligence and Machine Learning
• Augmented and virtual reality
• Digital pathology
• Credibility assessment in modeling
• Post-market signal response

The DIDSR department

• “Develops methods for evaluating the image quality of emerging imaging systems
• Develops methods for characterizing new medical image display devices
• Evaluates the dose reduction potential of new image reconstruction methods
• Assesses the performance of Artificial Intelligence and Machine Learning algorithms.
• Develops state-of-the-art methods for the design of clinical trials involving imaging devices and the evaluation of resulting trial data to enable more efficient and effective utilization of imaging data and more powerful clinical studies.”

Members of the DIDSR include science professionals in physics, biomedical engineering, electrical engineering, mathematics and statistics, medical radiology, and computer science.

The FDA and medical imaging

The FDA states that medical imaging refers to different technologies used to diagnose, monitor, and treat medical disorders. The technologies differ – but each type of technology generally focuses on disease, injury, and treatment of specific body areas. The FDA has guidance and regulations about the following types of medical imaging:

• Ultrasound Imaging
• MRI (Magnetic Resonance Imaging)
• Pediatric X-ray Imaging
• Medical X-ray Imaging
• Radiography
• Computed Tomography (CT)
• Dental Cone-beam Computed Tomography
• Fluoroscopy

One example of The FDA’s oversight of medical imaging – ultrasound imaging

The role of the FDA in the oversight of medical imaging technology can be quite confusing. Developers and users of various medical imaging technologies need to understand the FDA’s oversight roles. A failure to comply with FDA requirements can mean the technology cannot be used or marketed. Manufacturers may receive warning letters for noncompliance.  Our seasoned healthcare lawyers can provide more compliance review depending on the particular type and use for any specific medical technology.

One illustrative common digital imaging technology is ultrasound imaging.

What is ultrasound imaging?

The FDA states that:

“Ultrasound imaging (sonography) uses high-frequency sound waves to view inside the body. Because ultrasound images are captured in real-time, they can also show movement of the body’s internal organs as well as blood flowing through the blood vessels. Unlike X-ray imaging, there is no ionizing radiation exposure associated with ultrasound imaging.”

An ultrasound image is produced based on the reflection of the waves off of the body structures.

What are the uses for ultrasound imaging?

Ultrasound imaging helps doctors evaluate, diagnose and treat medical conditions. There are many uses for ultrasound including:

• “Abdominal ultrasound (to visualize abdominal tissues and organs)
• Bone sonometry (to assess bone fragility)
• Breast ultrasound (to visualize breast tissue)
• Doppler fetal heart rate monitors (to listen to the fetal heartbeat)
• Doppler ultrasound (to visualize blood flow through a blood vessel, organs, or other structures)
• Echocardiogram (to view the heart)
• Fetal ultrasound (to view the fetus in pregnancy)
• Ultrasound-guided biopsies (to collect a sample of tissue)
• Ophthalmic ultrasound (to visualize ocular structures
• Ultrasound-guided needle placement (in blood vessels or other tissues of interest)”

What are the benefits and risks of ultrasound imaging?

Generally, ultrasound, which has been used for more than 20 years, has an excellent safety record. Ultrasound is considered less dangerous than X-rays because ultrasound uses non-ionizing radiation unlike X-rays which use ionizing radiation. There are concerns though.

“Ultrasound energy has the potential to produce biological effects on the body. Ultrasound waves can heat the tissues slightly. In some cases, it can also produce small pockets of gas in body fluids or tissues (cavitation). The long-term consequences of these effects are still unknown.”

Because of the particular concern for effects on the fetus, organizations such as The American Institute of Ultrasound in Medicine has expressed concerns about the effects on the fetus of pregnant women. Using ultrasound to obtain “fetal ‘keepsake’ videos is generally discouraged. “Keepsake images or videos are reasonable if they are produced during a medically-indicated exam, and if no additional exposure is required.”

The FDA does recommend, for all medical imaging procedures that patients speak with their healthcare provider about why the need for the ultrasound examination, what medical information is needed, the risks, and how the results will be used.  Ultrasound is a commonly used medical imaging technique for viewing a fetus to determine the health of the fetus and mother.  Parents can hear a fetus’ heartbeat, bond with the unborn baby, and captures images for relatives and friends.

“In fetal ultrasound, three-dimensional (3D) ultrasound allows the visualization of some facial features and possibly other parts such as fingers and toes of the fetus. Four-dimensional (4D) ultrasound is 3D ultrasound in motion. While ultrasound is generally considered to be safe with very low risks, the risks may increase with unnecessary prolonged exposure to ultrasound energy, or when untrained users operate the device.”

There are additional concerns for expectant mothers such as the use of over-the-counter fetal heartbeat monitoring systems (also called doptones). “These devices should only be used by trained health care providers when medically necessary. Use of these devices by untrained persons could expose the fetus to prolonged and unsafe energy levels, or could provide information that is interpreted incorrectly by the user.”

Information for Health Care Providers

As part of the FDA’s Initiative To Reduce Unnecessary Radiation Exposure From Medical Imaging, FDA recommends that health care providers consider using ultrasound or MRIs, when medically appropriate, because ultrasound and MRIs have little or no ionizing radiation exposure.

Ultrasound imaging does introduce energy into the body, and laboratory studies have shown that diagnostic levels of ultrasound can produce physical effects in tissue, such as pressure oscillations with subsequent mechanical effects and rise in temperature. Therefore, FDA recommends that health care providers consider ways to minimize exposure while maintaining diagnostic quality when using ultrasound. As with all other imaging modalities, the principles of As Low As Reasonably Achievable (ALARA) should be practiced by health care providers.

Individual states also regulate the use of diagnostic ultrasound. Health care facilities that use ultrasound should regularly test the equipment to make sure they’re functioning properly.

Information for Industry: Ultrasound Manufacturers

Manufacturers of ultrasound equipment have additional compliance issues:

“Manufacturers of electronic radiation emitting products sold in the United States are responsible for compliance with the Federal Food, Drug and Cosmetic Act (FFDCA), Chapter V, Subchapter C – Electronic Product Radiation Control.”

“Manufacturers of ultrasound imaging products are responsible for compliance with all applicable requirements of Title 21 Code of Federal Regulations (Subchapter J, Radiological Health) Parts 1000 through 1005.”

Another example – MRI (Magnetic Resonance Imaging) | FDA

Magnetic Resonance Imaging (MRI) is a medical imaging procedure that makes images of the internal structures of the body. The images are made by the use of MRI scanners that use strong magnetic fields and radio waves (radiofrequency energy). “The signal in an MR image comes mainly from the protons in fat and water molecules in the body.”

“During an MRI exam, an electric current is passed through coiled wires to create a temporary magnetic field in a patient’s body. Radio waves are sent from and received by a transmitter/receiver in the machine, and these signals are used to make digital images of the scanned area of the body. A typical MRI scan last from 20 – 90 minutes, depending on the part of the body being imaged.”

For some MRI exams, intravenous (IV) drugs, such as gadolinium-based contrast agents (GBCAs) are used to change the contrast of the MR image. Gadolinium-based contrast agents are rare earth metals that are usually given through an IV in the arm.

Compliance issues for medical imaging software

Some medical imaging technology is becoming portable. The compliance issues for medical imaging technology are quite complex. We’ve reviewed digital health and the FDA (Part one and Part two), previously. We’ve also discussed mental mobile health apps, and many other related issues – depending on the type of digital health technology – including:

• Medical devices
• Software as a Medical Device
• Device software functions
• Artificial Intelligence and Machine Learning (AI/ML) in Software as a Medical Device,
• The Digital Health Center of Excellence Services
• Cybersecurity
• Mobile medical apps
• HIPAA

The manufacturers of medical imaging technology and the medical practices that recommend and use the technology should contact Cohen Healthcare Law Group, PC to review the federal and state compliance issues. Our experienced healthcare attorneys advise medical product companies and doctors about healthcare compliance laws and regulations.