Hitachi Medical Corporation (Tokyo, JP)
What is a Software Medical Device for Method and system for collecting image data from the image data collection area, including regularly moving components
Is Your Software a Medical Device for Method and system for collecting image data from the image data collection area, including regularly moving components
Images taken from the center of an object to examine and reconstructed using the data can cause image quality degradation due to the cardiac motion artifact (a heartbeat) and respiratory motion artifact (a thorax motion related with breathing).
A scanning method referred to as electrocardiographic synchronous scan (electrocardiogram) is employed. This involves collecting electrocardiographic data in order to minimize heartbeat motion artifacts. Then, the image data is gathered. The image is rebuilt using the data. For instance, in accordance with segment reconstruction, which is a form of cardiographic synchronousscanning, using cardiographic data using image data, the data gathered in diastole in which cardiac motions are very few are extracted and an image is reconstructed according to the information, to ensure that the image can be created with a preferred time resolution and with less motion artifact. Conditions for collecting image data such as speed of scanning and resolution is determined in accordance with the object to be examined. It is therefore important to maintain the heart rate in order to maintain the quality of an obtained image.
In order to avoid respiratory motion artifact, the object is typically made to hold his/her breath to prevent a thorax motion while collecting images. Patent document 1: Japanese Patent Application Laid-Open No. 2000-189412
In many cases, however, when an object is breathing the heart rate of their body tends more to fluctuate more than their resting rate. While heart rate fluctuations due to breath holding can vary between individuals, they do not affect the resolution of images obtained through cardiographic scans that are synchronous. Conditions of data collection for images that are suitable for resting heart rates produce images that have a better and more constant resolution. But, in actuality, the heart rate at the time of the data collection differs from that of the resting rate. Thus, a good image cannot be obtained when using the conditions for image data collection which are compatible with the resting rate.
The invention described hereinafter is designed to address these circumstances. The invention described herein provides an image data gathering method and a system to collect better image data, even if the heart rate of an object is fluctuating during the process of collecting image data.
In an aspect of this disclosure, there is provided an image data collection control method for collecting multiple pieces of image data from an image data collection range including a periodically moving part of an object to be examined, themethod including: a periodic motion data obtaining step of obtaining periodic motion data indicating changes of a periodic motion with time, an image data collection condition setting step of setting image data collection conditions for allowing theimage data of the image data collection range to have a time resolution within a desired range, an image data collection position control step of relatively moving at least a part of the image data collection range and the collection position of theimage data such that the part of the range and the collection position are superimposed on each other within a time when the image data of the image data collection range has a time resolution within the desired range based on the image data collectionconditions, and an image data collecting step of collecting the image data of at least a part of the image data collection range on the image data collection position.
In another aspect of this disclosure, there is provided an image data collection system for collecting multiple pieces of image data from an image data collection range including a periodically moving part of an object to be examined, the systemcomprising: a periodic motion data obtaining means for obtaining periodic motion data indicating changes of a periodic motion with time, an image data collection condition setting means for setting image data collection conditions for allowing the imagedata of the image data collection range to have a time resolution within a desired range, an image data collection position control means for relatively moving at least a part of the image data collection range and the collection position of the imagedata such that the part of the range and the collection position are superimposed on each other within a time when the image data of the image data collection range has a time resolution within the desired range based on the image data collectionconditions, and an image data collecting means for collecting the image data of at least a part of the image data collection range on the image data collection position.
In another aspect, changes of regular motion on a regularly moving object are assessed in the process of collecting images, and the gathering of data from images is managed accordingly, so that images can be gathered with a preferred time resolution.
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What is a software medical device?
The FDA refers to software functions which may include ” Software as a Medical Device” (SaMD) and “Software in Medical Device (SiMD) ), which is software that is integrated into (embedded within) the medical device.
Section 201(h) of the?Federal Food Drug and Cosmetic Act, ?21 U.S.C. 321(h),(1) defines a medical device to be?an apparatus, implements, machine, contrivance or implant, in vitro-reagent, or other similar or related items, including a component, or accessory. . . (b) designed for use in the diagnosis of disease or other conditions, or for the treatment, mitigation, treatment, or prevention of disease in animals or man, or (c) is designed to alter the structure or the functions of the human body or other animals.? To be classified as medical devices and thus subject to FDA regulations the software must meet at least one of these criteria:
- It should be designed to be used to diagnose or treat patients; or
- It must be designed to affect the structure or perform any functions of the body.
So, if your application is designed specifically for healthcare professionals to treat and diagnose patients, or is used in hospitals to handle patient information, the FDA is likely to view the programs as medical devices that are subject to review by the regulatory authorities.
Is Your Software a Medical Device?
In accordance with FDA’s current approach to oversight, which considers the functionality of the software, rather than its platform, FDA will apply its regulatory oversight only to medical devices that have functionality that could cause harm to patient safety. Some examples of Device Software and Mobile Medical Apps that FDA is focused on include
- Software functions to help patients with diagnosed psychiatric conditions (e.g. post-traumatic stress disorder (PTSD), depression, anxiety, or obsessive compulsive disorder) maintain their behavioral strategies for coping by offering the “Skill of the day” behavior technique or audio messages that users can listen to when experiencing increased anxiety;
- Software functions provide regular education information, reminders or motivational guidance to smokers trying to quit, patients recovering from addiction, or pregnant women;
- Software functions that use GPS location information to notify asthmatics when they are in high-risk areas (substance abusers) or to warn them to conditions in the environment that may trigger symptoms.
- Software functions that employ video and video games to motivate patients to perform their exercise routines at home;
- Software functions that let users choose the medicine or substance they want to consume simultaneously. They also give information about interactions , and provide an overview of the type of interaction.
- Software functions that consider the characteristics of patients, like gender age, gender, as well as risk factors, to offer individual counseling, screening and prevention recommendations from established and well-respected authorities.
- Software functions that make use of a checklist of common symptoms and signs to provide a list of possible medical conditions and advice on when it is appropriate to speak with a health care provider;
- Software functions guide the user through a checklist of symptoms and signs to provide a recommendation for the kind of health care facility most appropriate to their needs;
- Mobile apps are designed to allow a user to initiate a pre-specified emergency or nurse call by using broadband or cell phone technology;
- Mobile applications that permit a patient or caregiver to create and send an alarm or general emergency alert to first responders.
- Software functions keep track of medications and provide user-configured reminders to ensure better medication adherence;
- Software functions give users access to their health records. This includes historical trends as well as comparisons of vital signs (e.g. body temperature and heart rate pressure).
- Software functions that aggregate and display trends in personal health events (e.g., rate of hospitalization or alert notification rates);
- Software features permit users to either manually or electronically input blood pressure information, to share it with e-mail or track it, and then trend it, and then upload it into your personal or electronic health record.
- Apps that offer mobile apps to monitor and remind you regarding oral health, or tools to track those suffering from gum disease.
- Mobile applications that offer patients suffering from prediabetes with advice or tools to assist them establish better eating habits or increase physical activity
- Apps that let users display pictures and other messages on mobile devices. These apps are a great option for substance abusers who want to end their addiction.
- Software functions that offer drug-drug interactions and relevant information about safety (side effects or drug interactions, active ingredient) as a report that is based on demographic information (age, gender) and medical information (current diagnosis) and the status of current medications as well as
- Software functions give the surgeon the list of suggested intraocular lens powers and recommended axis of implantation based on the inputs of the surgeon (e.g., expected surgically-induced astigmatism that is likely to occur, patient’s axial length , cornea astigmatism before surgery, etc.)
- Software, usually mobile apps that convert a mobile platform into a regulated medical device.
- Software that connects to a mobile platform by using a sensor or lead to monitor and display the electrical signals generated by the heart (electrocardiograph, ECG).
- Software that attaches a sensor to the mobile platform or other tools in the platform, that allow users to see or record the eye movements to detect balance disorders
- Software that collects data about potential donors, and then transmits the information to the blood collection facility. The software can determine whether a person is eligible to receive blood or any other component.
- Software that connects with the device’s type in order to control its operation, function, or energy source.
- Software that alters the settings or function of an infusion pump.
- Software that controls the deflation or inflation of a blood pressure cuff
- Software is used to calibrate hearing devices and evaluate the electroacoustic frequencies, audio intensity characteristics, as well as sound quality of hearing aids, master hearing aids, group hearing aids, or auditory trainers for groups.
What does it mean if your software/SaaS is classified as a medical device?
SaaS founders need to be aware of the compliance risks that medical devices pose. Data breaches are one of the biggest risks. Medical devices often contain sensitive patient data, which is why they are subject to strict regulations. This data could lead to devastating consequences if it were to become unprotected. SaaS companies who develop medical devices need to take extra precautions to ensure their products are safe.
So who needs to apply for FDA clearance? The FDA defines a ?mobile medical app manufacturer? is any person or entity who initiates specifications, designs, labels, or creates a software system or application for a regulated medical device in whole or from multiple software components. This term does not include persons who exclusively distribute mobile medical apps without engaging in manufacturing functions; examples of such distributors may include the app stores.
Software As Medical Device Patenting Considerations
The good news is that investors like medical device companies which have double exclusivity obtained through FDA and US Patent and Trademark Office (USPTO) approvals. As such, the exit point for many medical device companies is an acquisition by cash rich medical public companies. This approach enables medical devices to skip the large and risky go-to-market (GTM) spend and work required to put products in the hands of consumers.
Now that we have discussed the FDA review process, we will discuss IP issues for software medical device companies. Typically, IP includes Patents, Trademarks, Copyrights, and Trade secrets. All of these topics matter and should be considered carefully. However, we will concentrate on patents to demonstrate how careless drafting and lack of planning can lead to problems, namely unplanned disclosures of your design that can then be used as prior art against your patent application.
In general, you should file patent application(s) as soon as practicable to get the earliest priority dates. This will help you when you talk to investors, FDA consultants, prototyping firms, and government agencies, among others. Compliance or other documents filed with any government agency may be considered disclosure to third parties and could make the document public. In general, disclosures to third parties or public availability of an invention trigger a one year statutory bar during which you must file your patent application. Failure to file your application within the required time frame could result in you losing your right to protect your invention.
The information from your FDA application may find its way into FDA databases, including DeNovo, PMA and 510k databases and FDA summaries of orders, decisions, and other documents on products and devices currently being evaluated by the FDA. Your detailed information may be gleaned from Freedom of Information Act requests on your application. This risk mandates that you patent your invention quickly.
When you patent your medical device invention, have a global picture of FDA regulatory framework when you draft your patent application. Be mindful of whether your software/SaaS application discusses the diagnosing and treating patients or affecting the structure or function of the body and add language to indicate that such description in the patent application relates to only one embodiment and not to other embodiments. That way you have flexibility in subsequent discussions with the FDA if you want to avoid classification of your software/SaaS/software as a medical device. In this way, if you wish to avoid FDA registration and oversight, you have the flexibility to do so.
An experienced attorney can assist you in navigating the regulatory landscape and ensure that you comply with all applicable laws. This area of law is complex and constantly changing. It is important that you seek legal advice if you have any questions about whether or not your software should be registered with FDA.
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