General Electric Company (Schenectady, NY)
What is a Software Medical Device for System and method for perspective-based procedure analysis
Is Your Software a Medical Device for System and method for perspective-based procedure analysis
The present invention generally addresses perspectives in the healthcare environment. Particularly the present invention pertains to use of medical perspectives to improve medical image reading and workflow.
The healthcare environment is highly crowded and stressful environments that can benefit from improved organization and a simpler utilization of data storage systems as well as imaging systems. Ahealthcare environment, such as the hospital or clinic includes a variety of patients, professionals, and equipment. Healthcare workers are required to oversee a variety of patients, systems, and tasks to ensure quality care to patients. Healthcare personnel may encounter many difficulties or obstacles when working.
A variety of distractions in a clinical environment may frequently hinder medical personnel or interfere with their job work. Additionally, workplaces like a radiology workspace, may become cluttered with a variety of monitors, input devices for data and storage devices for data, and communications devices like. A messy workspace could hinder productivity and hinder customer service. This could impact the safety of the patient and their health as well as raise the risk of liability for the healthcare facility. Access to and entry of data can be a challenge in a typical healthcare facility.
Healthcare environments, such as clinics or hospitals, have medical information systems including hospitals information systems (HIS) and radiology information systems (RIS) as well as storage systems, such as picture archiving and communication systems (PACS). The information stored could include medical history, imaging data, test results, diagnosis information, management information and/or scheduling information for instance. Information can be stored centrally or distributed across several locations. Patients’ information and other data may be sought out by healthcare professionals at various stages of a healthcare workflow. Medical personnel may have access to information about patients, such as images of the patient’s anatomy during surgery. This information is stored in the medical system. Additionally, medical personnel can add new information, such as history, diagnostic, or treatment information into a medical information system during an ongoing medical procedure.
It can be difficult to setup and operate imaging systems. In many instances, healthcare professionals will be looking for an image of a patient, reference or update records of a patient or diagnosis, and ordering additional tests or consult. A method and system to facilitate interoperability between an imaging system, as well as other devices is necessary.
A reading (also called a radiology or cardiology procedure reading) is the procedure that a healthcare professional like a doctor or cardiologist views digital images of a patient. The physician makes diagnosis based on content ofthe diagnostic images and then reports the results electronically (e.g., using the dictation method or other) or in writing. The practitioner, for example, a radiologist or cardiologist, generally utilizes other instruments to carry out diagnosis. Other instruments include prior and similar (historical) tests, laboratory tests (such as bloodwork) allergies test results, pathology, medication, alerts and document images and other documents, among others.
To format images such as mammograms, the current systems use different techniques known as “hanging protocols”. Hanging protocols provide an unidirectional perspective to the user for example, a radiology specialist. Images can be grouped in accordance with simple, non-specific characteristics such as series numbers or DICOM series. Single perspectives usually contain all images that are available of a patient or study. Single perspectives are often too broad and create extra work for radiologists or other reviewers. Single perspectives are built on the characteristics of one particular instance of an operation. However, the characteristics of a procedure might differ for different scenarios of the procedure. For instance, an auser, such as radiologists are typically needed to create images upon display or create the new protocol completely. The development of the new protocol is a tedious, time-consuming task. The manual sorting and hanging of images are time-consuming. A method and system to improve the sorting and display of images for review would be appreciated.
There is a requirement for a system and method to improve workflow and efficiency using medical perspectives to improve the quality of medical imaging and workflow.
The present invention offers a method and system that allows medical perspectives to be utilized to improve the efficiency of the medical workflow. Apicture archiving system and communication system (PACS) and workstation which can be used to review images, and at least one display that can display images for review are some examples of medical perspectives. The default perspective comprises the first set of images that are organized according to a predetermined selection of criteria. The default perspective is used for reviewing the first plurality via the PACS system. It also has an additional perspective that permits users to select the second perspective to view the second plurality images via the PACS Workstation. The system can contain multiple perspectives.
The second plurality is a subset of that is the primary plurality. For instance the default criterion may allow the display all images. The second criteria could be image attributes such as procedural-specific image attributes. The second perspective could comprise a layout of the second plurality of images based on the image attributes.
The system could also comprise at least one tool that allows to manipulate and/or navigate of images. The tool(s) could let a user move around and/or manipulate one or more images simultaneously in a perspective. The system could also comprise a template for recording findings for report generation. The template may contain a variety of screening results that are able to be selected by the user, as an example.
A method for providing medical perspectives for better screening analysis includes providing an initial view for viewing images on an PACS computer system. This default perspective lets a user select another perspective for reviewing images displayed on PACS computer. This second view contains a second plurality images that have been organized according to a secondcriterion. The default criteria may permit the display of all images available, for example. The second criterion may include images with attributes, like procedure-specific image attributes for instance.
A preferred embodiment of the method includes manipulating and/or navigating image(s) in the first or second plurality. Navigation and/or manipulation may include the manipulation and/or navigation of one or more images in asynchronous manner within a view like. A method may comprise the creation of a report based on various screening results that could be selected by the user.
A system for image analysis that uses perspective has a default perspective that contains an initial set of images arranged in accordance with a standard criteria and a second perspective that includes another set of images organized according to another criterion. The default perspective is used to review the first group of images via a PACS workstation. The second perspective can be selected by the user to review the second set of images using the PACSworkstation. For example the second group is a subset of the first plurality. The second criteria is made up of image attributes, for example.
A computer-readable storage medium which contains instructions for a computer may include a program for managing perspectives to manage a range of perspectives, which includes images. Additionally, it includes an algorithm for processing images in the perspectives according at least one of editing functions, display functions, or transmission functions. The routine for managing perspectives allows users to switch between perspectives to view various layouts for instance. A report routine could be added to the set of instructions to produce reports using a template that includes analysis results related to the perspectives. A perspective creationroutine may be part of the instructions set to create at minimum one perspective using imaging-specific attributes.
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What is a software medical device?
The FDA refers to software functions that may comprise ” Software as a Medical Device” (SaMD), and “Software in a Medical Device (SiMD) ), which is software that is integral to (embedded in) an 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, device, machine, device, or contrivance or in vitro-reagent, as well as other similar or related articles that include a component or accessory. . . (b) is intended to detect diseases or other conditions, or treat, mitigate or treat them. (c) can have the potential to alter the structure or function of the body of other animals. Thus, to be considered a medical device and therefore subject to FDA regulations, your software must satisfy one of two criteria:
- It should be used for the diagnosis and treatment of patients.
- It is not intended to alter the structure or perform any purpose of the body.
If your program is intended to be used by healthcare professionals to diagnose treat or manage patient data in hospitals and other medical facilities, the FDA is likely to consider the software to be medical devices subject to regulatory review.
Is Your Software a Medical Device?
As per FDA’s current oversight approach that examines the capabilities of the software more than the platform, FDA will apply its regulation only to medical devices with functionality that could cause harm to the safety of patients. Examples of Device Software and Mobile Medical Apps that FDA is focused on include
- Software functions that aid those suffering from mental illness (e.g. depression, anxiety, post-traumatic stress disorder (PTSD) and others.) by offering “Skill of the Day” an approach to behavior, or audio messages, that users can access when experiencing anxiety.
- Software functions that offer periodic reminders, motivational advice, and educational information to patients who are recovering from addiction, or who are trying to quit;
- Software functions that utilize GPS location data to warn asthmatics to conditions in the environment that could trigger asthma symptoms, or to alert an addiction patient (substance addicts) in proximity to a specified high-risk area;
- Software functions that employ games and videos to encourage patients to perform their exercises in their own homes;
- Software functions that prompt users to select the herb or drug they would like to take in conjunction and offer information about the possibility of interactions in the literature as well as a summary of what type of interaction was described;
- Software functions that take into account specific characteristics of patients, such as gender age, gender, and other risk factors, in order to provide individual counseling, screening and preventive advice from established and respected experts.
- Software functions that make use of a checklist of common symptoms and signs to give an overview of medical conditions and advice on when to consult an expert in health care;
- Software functions guide a user through a questionnaire of signs and symptoms to offer a recommendation on the type of health care facility most appropriate to their needs;
- These mobile applications allow users to make pre-specified nurse calls as well as emergency calls with the internet or cell phone technology.
- Mobile applications that permit the patient or caregiver to create and send an alert or general emergency notification to emergency responders.
- Software functions that keep track of medications and provide user-configured reminders for improved medication adherence;
- Software functions allow patients access to their health records. This can include historical trending and comparisons of vital signs (e.g. body temperature, heart rate or blood pressure).
- Software functions that display patterns in personal health incidents (e.g. hospitalization rates or alert notification rate)
- Software features permit users to either manually or electronically enter blood pressure data, and to share it via e-mail as well as track and track it, and then upload it into your personal or electronic health record.
- Mobile apps that offer oral health reminders and tracking tools for those suffering from gum disease;
- Apps that give mobile users access to information and aids for prediabetes patients;
- Mobile apps that show when appropriate messages or images to a user of a substance who wants to stop addictive behavior;
- Software functions that report drug interaction and safety information (side effects and drug interactions active ingredient, active ingredient) in a report based upon information about demographics (age and gender) as well as current diagnoses (current medications) and clinical data (current treatment).
- Software functions allow surgeons to identify the best intraocular lens powers for the patient and the axis of implantation. The information is based on the surgeon’s inputs (e.g., expected astigmatism caused by surgery, the length of the patient’s axial and cornea astigmatism prior to surgery, etc.).
- Software, typically mobile apps which convert a mobile platform to a regulated medical device.
- Software that connects with a mobile platform via an instrument or lead to measure and display electrical signals coming from the heart (electrocardiograph; ECG).
- Software that connects a sensor to the mobile platform, or other tools in the platform, to view the eye movements, record and analyze the eye movements to identify balance issues
- Software that gathers information about potential donors, and then transmits it to an institution for blood collection. This program is used to determine if a person is eligible to collect blood or other components.
- Software that connects to an existing device type to regulate its function, operation, or energy source.
- Software that alters the functions or settings of an infusion pump
- Software that regulates the inflation and deflation of the blood pressure cuff
- Software is used to calibrate hearing devices and evaluate the electroacoustic frequency, the characteristics of sound intensity, and sound quality of hearing aids master hearing aids hearing aids that are group-based 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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