Apteryx, Inc. (Akron, OH)
What is a Software Medical Device for System and method to automate the generation of a query for a DICOM server
Digital Imaging and Communications in Medicine is a standard that allows images as well as other data to be transferred between different devices. In general, DICOM servers DICOM server can be used to store, organize, and managemedical images. Different systems can want to work with the DICOM server to store images to the DICOM server and/or access images stored on the DICOM server by submitting requests to the DICOM server.
However the DICOM standard provides for more than just the transferring and storage of digital medical images. Other DICOM functions include media storage queries and retrievals, worklist queries and making image hard copies as well as study and result management printing management managing worklists, and testing connectivity verification.
A fundamental concept within the DICOM standard is that of “Services on Objects”. A X-ray image is an instance of an object. The “query/retrieve and “store” functions are just two instances of “services”. The DICOM standard is a reference to processes that operate on objects in the form of “Service Object Pair Classes” or SOP Classes. Some examples of SOP Classes include “store an image using X-rays”, “print an X-ray image” and “retrieve an X-ray worklist”.
Unique Identifiers (UID’s) are determined for SOP classes, and can be applied to series, studies as well as images. A study of a patient includes the study element, for example for instance, an examination with a specific kind of medical imaging machine.The images that are taken in sequence during the examination on a patient create the form of a sequence of objects.
The DICOM standard is founded on the concept of a server/client. A device that uses services is called a client device, while the device that delivers the service is called the server device. A Service Class User (SCU) is the client device. The serverdevice is called the Service Class Provider (SCP). An SCU sends a Service Request to an SCP via the network. The SCP is then able to transmit back to the SCU with a response via the network. To transfer information between a SCP and a SCU the communicationsyntax has to be agreed upon an association between the SCU and the SCP must be opened.
DICOM is a standard for the communication of digital images from medical kinds like X-rays and computerized tomography, as well as magnetic resonance. DICOM operations are handled in a queued fashion by application software running on a host computer. The host computer could be an integral component of a medical imaging system.
A typical user of a computer has to manually enter the patient’s information into fields of an application window, which can be used as search terms for an inquiry. The manual entry of patient data is not efficient and is prone to mistakes.
A different limitation and disadvantage of conventional, traditional, and proposed approaches will be apparent to those experienced in the field when comparing these methods and systems to the present invention, as detailed in the rest of the present application and with reference to the illustrations.
A specific embodiment of the invention provides a method to automatically create a query for a DICOM server. This method involves reading patient identification data using the use of a barcode scanner. The patient identificationinformation is encoded in a bar code on, for example, a patient identification card belonging to a patient. This technique also involves transmitting the patient’s data automatically from the bar scanner device to an application running on the computer platform. A DICOM query operation is then launched to find at minimum one DICOM server, based at least on a portion of the patient’s identity information and making use of the medical software application.
A system that automatically generates a query to a DICOM Server is an additional version of the invention. The system comprises an encoded medium that contains encrypted patient information. A reader device is integrated into the system to read the encoded information of the patient. The system also comprises a computer-based platform hosting a medical software application. The computer-based platform interfaces with the device that reads the patient’s data and then generate DICOM queries with the software. The DICOM query includes at least a portion of the patient identificationinformation. In addition, the system contains at least one DICOM Server that is operationally connected to platforms that run on computers to receive the DICOM query over a network.
Another version of the invention allows for an automatic generation of a query for the DICOM Server. The method includes reading patient identification information using a reading device, wherein the patient identificationinformation is encoded on a tangible medium. The method also includes forwarding the identified patient information from the device to an medical software application running on an electronic platform. The method also involves the process of initiating a DICOM query operation to locate at least one DICOM servers, using at most one a part of the patient’s identity information using the software.
These and other advantages as well as unique features of the present invention, along with the specifics of an illustrated example of its embodiment will be better appreciated from the subsequent description and illustrations.Click here to view the patent on USPTO website.
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What is a software medical device?
The FDA could refer to the functions of software, which include ” Software As a Medical Device” and “Software in a Medical Device(SiMD)”, which are functions of software that are integral to (embedded in) medical device.
Section 201(h) of the?Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 321(h),(1) defines medical devices as apparatus, implements or machine implants, devices, contrivances in vitro regulator, and other related items in addition to a component or accessory. . . (b) is intended to diagnose or treat disease or other conditions in animals or humans. (c) is designed to alter the structure or functions of animals or human bodies. To qualify as a medical device and consequently subject to FDA regulation, the software must meet at least one of the following requirements:
- It should be used for diagnosing and treating patients.
- It should not be designed to alter the structure or function of the body.
Thus, if your software is specifically designed for healthcare professionals to treat and diagnose patients, or is used in hospitals to manage patient information The FDA will likely consider such programs as medical devices that are subject to review by the regulatory authorities.
Is Your Software a Medical Device?
As per FDA’s current approach to oversight that looks at the capabilities of the software more than the platform, FDA will apply its supervision only to devices for medical use that possess functions that cause harm to the safety of patients. Some examples of Device Software and Mobile Medical Apps that FDA is looking at include
- Software functions that aid those suffering from psychiatric disorders diagnosed (e.g. post-traumatic stress disorder (PTSD), depression, anxiety, obsessive compulsive disorder) maintain their behavioral coping skills by providing an “Skill of the day” behavior technique or audio-based messages the user can use when they are experiencing an increase in anxiety;
- Software functions that offer periodic reminders, motivational support, and educational information to those recovering from addiction, or smokers who want to stop.
- Software functions that use GPS location information to notify asthmatics of environmental conditions that may cause asthma symptoms or alert an addiction patient (substance addicts) in proximity to a specified, high-risk location;
- Software that uses video and games to encourage patients to exercise at home.
- Software functions that prompt the user to input the herb or drug they would like to take concurrently and provide information about the likelihood of interactions being reported in the literature as well as a summary of what type of interaction was observed;
- Software functions that utilize patient characteristics like age, sex, and behavioral risk factors to provide patient-specific screening, counseling and preventive recommendations from well-known and reputable authorities;
- Software functions that utilize a checklist to determine common symptoms and provide guidance on when to see a doctor.
- Software functions that help users to complete a questionnaire about their symptoms and then make a recommendation on the best type of health care facility for their needs.
- Mobile apps are intended to allow a user to make a pre-determined nurse call or emergency call using broadband or cellular phone technology;
- Apps that allow patients or caregivers to communicate emergency alerts to first responders through mobile phones
- Software functions that track the use of medication and offer the user with a customized reminder system to help improve medication adherence;
- Software functions that give patients a portal into their personal health records for example, access to information captured during a prior visit to a doctor or historical trends and comparison of vital indicators (e.g., body temperature or heart rate, blood pressure or respiratory rate);
- Software functions that show patterns in personal health incidents (e.g. hospitalization rates or alert notification rates)
- Software functions allow users to gather (electronically or manually input) blood pressure data and share this data through e-mail or track and analyze it, or even upload it to an electronic or personal health record.
- Mobile apps that allow to track and remind users about oral health, or tools to track users who suffer from gum disease.
- Mobile apps that give patients suffering from prediabetes advice or tools that can help them develop better eating habits or increase physical exercise
- Applications that permit users to display images and other messages on smartphones, which are a great option for substance abusers who want to end their addiction.
- Software functions that provide interactions between drugs as well as relevant safety information (side effects, drug interactions and active ingredient) in a report basing on demographic data (age, gender) as well as medical information (current diagnosis) and the current medication and
- Software functions give the surgeon an inventory of intraocular lens power and suggested axis of implantation based on information supplied by the surgeon (e.g., predicted surgically induced astigmatism patient’s axial length and preoperative corneal astigmatism, etc.)
- Applications, mostly mobile that transforms a mobile platform into a regulated medical device.
- Software that is connected to a mobile device using a sensor or a lead to measure and display the electrical signals produced by the heart (electrocardiograph, ECG).
- Software that attaches sensors or other tools to the mobile device to view eye movements to detect balance problems.
- Software that collects information about potential donors, and then transmits it to an institution for blood collection. The software will determine whether a person is eligible to receive blood or other components.
- Software that connects to an existing device type in order to control the device’s operation, function or power source.
- Software that alters or deactivates the functions of an infusion pump.
- Software that regulates the inflation or deflation of a blood pressure cuff
- Software that is used to calibrate hearing devices and evaluate the electroacoustic frequencyand the characteristics of sound intensity, and coming from hearing aids, master hearing aids, group hearing aids, or auditory trainers in 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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