General Electric Company (Schenectady, NY)
What is a Software Medical Device for Machine learning systems and methods that are based on hanging protocols
Is Your Software a Medical Device for Machine learning systems and methods that are based on hanging protocols
The invention is generally referred to hanging protocol configuration in picture archiving and communication systems. In particular, certain embodiments of the present invention relate to machine learning based hanging protocolconfiguration in a picture archiving and communication system.
Hospitals and clinics have clinical information systems for clinical information. They include radiology information systems (“RIS”) and hospital information systems (“HIS”) and storage systems like picture archiving systems as well as communication systems (“PACS”)). Information stored can include medical history, imaging information, test results, diagnosis information, management information, and/or scheduling information, for instance. The information may be centrally stored or stored into multiple locations. Healthcare professionals may want access to patient information or other data at different locations in the healthcare workflow. For example during surgery, medical staff might access patient information including images of the patient’s anatomy, which are kept in a health information system. Alternatively, medical personnel may add any new information, like the patient’s history, diagnostic or treatment details, into the medical information system in an ongoing medical procedure.
A reading (also known as a cardiology or radiology procedure reading) is the procedure in which a healthcare professional such as a doctor cardiologist views digital images of patients. A practitioner makes diagnoses using the contents of diagnostic images. The doctor can report on the findings electronically (e.g. via dictation or other means) or on paper. A cardiologist or radiologist could utilize other diagnostic tools. Other tools include prior and similar (historical) examinations as well as lab tests (such as bloodwork) allergies tests, results from pathology and medications, alerts and document images, among others.
Picture archiving, communication and systems (“PACS”) connect with medical diagnostic imaging devices. They make use of an acquisition gateway (between PACS and the acquisition device), storage andarchiving units, display workstations and databases, and advanced data processors. The components are connected via an information management system as well as a communication network. The main purpose of a PACS is to simplify the health-care process to facilitate remote diagnosis and examination as well as improve the quality of care for patients.
The most common use of PACS systems is to provide PACS system is to provide one or more medical images to be examined by a medical professional. A PACS system can send the x-ray images to an x-ray display station where they are displayed for the radiologist to make a diagnosis. Radiologist can make a diagnosis based on the images presented. Radiologist are able to identify tumors or lesions in x-ray images of the lungs of the patient.
To format display and layout images current PACS systems employ a range of methods known as “hanging protocols”. A user can display images in accordance with the anatomy, modality, or procedure by using hanging protocols. The user is able to view the view from a different angle using hanging protocols, for instance the radiologist. Images can be classified by characteristics, such as DICOM series, or series numbers.
PACS systems also try to prepare images for users through the application of a set of processing functions or steps in a Default Display Protocol (“DDP”)). A DDP is an initial workflow that uses an image-processing set of actions to image data in order to prepare the data for display to a specific configuration of monitors. DDPs typically contain steps or functions that are used before taking a look at the images. DDPs may depend on the type of imaging method used to get the data. A DDP strives to present information about images in the most user-friendly format possible.
Hanging protocol, also known as DDP algorithm, in PACS applications currently uses the individual data elements of the DICOM head of an image and the HL-7 order information. This lets you categorize the type of study and determine how it should be displayed.
The invention provides methods and systems that enable the creation of a hanging procedure for displaying clinical images within the course of a study.
Certain embodiments include an approach to making a hang-up procedure for clinical image display. This method involves capturing the high-level characteristics for an image study that is based on the relationship among images in the study. Themethod is also used to identify some or all of the low-level characteristics for individual images in the image study. The method further includes classifying the image study based on a combination of the high level characteristics and the low levelcharacteristics. Based on the classification, the method also includes the determination of an appropriate hanging method to display the images within the study. The method also provides the hanging method for showing images in the study.
Certain embodiments allow for the possibility of showing clinical images that can be examined. The system is comprised of an input that receives one or more images from an image study to display. A machine learning engine chooses an image hanging protocol to display the images. The machine learning engine identifies one or more high level features of the image study in relation to the relationship between images within the study. The machine learning engine determines specific characteristics at a low level of images within the image study. A combination of high-level characteristics and low-level characteristics are used by the machine learning engine to categorize the study. Based on the classification, the machine learning engine determines the hanging procedure for the study. Further, the system outputs the hanging protocol to be used in displaying the images.
Certain embodiments offer a machine-readable storage medium including instructions that can be executed on the processor. The instructions include an input routine which receives one or more images in an image study to display. A machine learning routine selects the hanging method for displaying the images. The machine learning procedure records one or more high-level features of the study of the images by analyzing the relationships between images within the study. The machine learning algorithm identifies one or more low level characteristics for individual images in the image study. The machine learning program determines the quality of the image study on the basis of a combination of high level characteristics and the low level characteristics. The machine learning routine determines a hanging method for the image study based on the classifying. The set of instructions further contains an output routine that provides the hanging procedure for the display of one or more images.
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What is a software medical device?
The FDA is referring to the functions of software that can include ” Software as a Medical Device” (SaMD), and “Software in Medical Device (SiMD) ), which is software that is part of (embedded within) the medical device.
Section 201(h) of the Federal Food and Drug Act, ?21 U.S.C. 321(h),(1) defines a medical device to be?an apparatus, device, machine, contrivances, implant in vitro regulators, or any other similar or related items, as well as an accessory or component. . . (b) designed for use in the diagnosis of disease or other conditions, or for the cure, mitigation, treatment, or prevention of disease, for animals or humans or (c) intended to affect the structure or functions of the human body or other animals.? So, in order to qualify as medical devices and thus subject to FDA regulation, your software must meet two requirements:
- It must be intended for the treatment or diagnosis of an individual patient.
- It must not be designed to change the structure or function of the body.
If your program is intended to be utilized by health professionals to diagnose, treat, or manage patient information in hospitals or other healthcare facilities, the FDA will likely consider such software to be medical devices and subject to review by the regulatory authorities.
Is Your Software a Medical Device?
FDA is only applying its regulatory oversight only to medical devices with functionality that could be dangerous to the safety of patients according with the current FDA oversight approach. FDA currently considers the capabilities of the platform over the device’s functionality. Some examples of Device Software and Mobile Medical Apps that FDA is focused on includes
- Software functions to aid those suffering from mental illness (e.g., depression, anxiety, and post-traumatic stress disorder (PTSD), etc.) by providing “Skill of the Day”, a behavioral technique or audio message which the user is able to access when suffering from anxiety.
- Software functions that provide periodic education information, reminders or motivational advice to smokers who want to quit, addicts recovering from addiction, and pregnant women;
- Software functions that use GPS location data to warn asthmatics of conditions in the environment that may cause asthma symptoms, or to notify an addiction patient (substance abusers) in proximity to a specified high-risk area;
- Software functions that use video and video games to encourage patients to do their exercises in their own homes;
- Software functions that require users to select the herb or drug they wish to take concurrently and provide information about whether interactions have been observed in the literature as well as an explanation of what kind of interaction was observed;
- Software functions that utilize patient characteristics such as age, gender and other risk factors for behavior to provide patient-specific screening as well as preventive counseling from well-known and reputable authorities;
- Software functions that make use of a list of common symptoms and symptoms to give advice about when to see the doctor and what to do next.
- Software functions assist users in completing an assessment of their symptoms and signs, to offer an indication of the kind of health care facility most suitable to their requirements;
- These mobile apps allow users to make nurse calls or emergency calls using broadband or cell phone technology.
- Apps that permit patients or caregivers to notify emergency situations to first responders using mobile phones
- Software functions keep track of medication and offer user-configured reminders to help improve drug adherence
- Software functions allow patients access to their health records. This can include historical trending as well as comparisons of vital sign (e.g. body temperature, blood pressure, or heart rate).
- Software functions that aggregate and display trends in personal health incidents (e.g. rates of hospitalization or alert notification rates);
- Software functions that allow users to gather (electronically or manually input) blood pressure data , and transmit this data via email, track and trend it, or even upload it to an electronic or personal health record.
- Apps that provide mobile applications for tracking and reminders of oral health or devices to monitor users suffering from gum disease.
- Mobile apps offer patients with prediabetes guidance or tools to assist them improve their eating habits or increase their physical exercise;
- Mobile apps that display, at opportune times pictures or other messages to a substance abuser who wants to stop addictive behavior;
- Software functions that give drug interaction and safety information (side reactions and interactions with drugs, active ingredient active ingredient) in an analysis based on demographic data (age and gender) and current diagnosis (current medication) and clinical data (current treatments).
- Software functions that allow surgeons to determine the most effective intraocular lens power for the patient and the optimum axis of implant based on the information provided by him (e.g. anticipated surgically-induced astigmatism, the length of the patient’s axial, cornea astigmatism, etc.).
- Software, typically mobile apps that transforms mobile platforms into an approved medical device.
- Software that connects with a mobile platform via the use of a lead or sensor to measure and display electrical signals from the heart (electrocardiograph; ECG).
- Software that connects sensors or other instruments to the mobile device in order to view, record and analyze eye movements to diagnose balance problems.
- Software that gathers data about potential donors, and then transmits it to a blood collection facility. The software will determine the eligibility of a potential donor to donate blood or other components.
- Software that is connected to an existing device to control its operation, function, or energy source.
- Software that alters or disables the functions of an infusion pump
- Software that regulates the inflation and deflation of a blood pressure cuff
- Software that is used to calibrate hearing aids and to evaluate the electroacoustic frequencyand the characteristics of sound intensity, and coming from 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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