Siemens Aktiengesellschaft (DE)
What is a Software Medical Device for Software upgrades that are centralized in preparation
Is Your Software a Medical Device for Software upgrades that are centralized in preparation
Customer personnel can install and use interactive software at various customer locations. Interactive software are able to connect to medical applications, such as. Software applications are used to assist medical professionals in hospitals and other medical establishments. Software applications can be used to support medical imaging equipment and methods. The software applications also may facilitatemaintaining and updating medical files associated with individual patients. Software applications can be targeted at other kinds of applications including non-medical and medical.
Occasionally, the software applications in use are revised and updated. However, installing the new software can be time-consuming and cumbersome. An experienced software technician is typically required to install the software updates on each customer’s computers. The technician must first backup all user information and settings for the custom application once he arrives at the customer’s facility. After saving the custom application settings, the technician installs the latest version of the application software. The technician then reinstalls the settings he has customized that they saved.
After the installation of the new software, protocols between the client and the customer such as hardware or specific protocols may require to be changed in order to make the software compatible.
A system and method that allows remote service centers to at least partially upgrade software applications. Customers can use interactive software at various customer service centers that are dependent on customer records and protocols. A new or revised version of an interactive software application might be available for use. Remote service centers can be able to identify the customer-specific data and/or customer protocols that were utilized in the previous version of the interactive software in each customer facility. In the following steps, the revised version of the application may be modified by the remote service center utilizing the customer specific information and/or protocols for customers. The revised version of the software application which incorporates particular customer’s data and/or protocols may then be transferred to the customer facility to be installed.
One embodiment of the method involves updating software from remote service centres. This method involves receiving customer data about a previous version software application from a customer in a remote location, and then modifying the revised software application in the remote center using the customer data. This may also include the transfer of the updated software application to the customer.
A method of upgrading software at remote service centers is an additional embodiment. This method involves receiving customer protocol data which identifies the protocols of customers for a previous versionof software program from a client at a remote center, and then modifying the data of the customer to ensure it is compatible with the updated software program at the remote centre. The modified customer protocol information can be transferred to the customer’s place of residence.
In a different embodiment, a computer system for data processing upgrades software from remote service centers. Remote service centers have an internal memory unit that is able to store a modified version of the software. Processing units are also integrated into the system. It can receive the customer’s data from a client and save it to the memory unit. The processing unit alters the updated version of the application using the customer specific data. The system is then able to transfer the revised software application to the customer.
Another embodiment provides instructions that are executable on a computer by means of computer-readable media. The instructions instruct the computer to receive particular customer data from a location belonging to a customer that is linked to a user interface that is customized of a previous versionof a software application, modifying the version of the software application by using the specific customer data and transferring the revised version of the software application to the customer location. The revised version of the software application is altered to use an interface for users that is substantially similar to the custom user interface of the earlier version of the application.
The following explanation of preferred embodiments, which has been illustrated and shown to illustrate, will make the advantages clearer to those who are skilled in the art. The method and system can be altered in a variety of ways. Drawings and descriptions are meant to be considered illustrative and not limiting.
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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 integrated into (embedded inside) the medical device.
Section 201(h),?21 U.S.C. 321(h)(1) defines the term “medical device” as instrument, apparatus, instrument or device, contrivance implant or in vitro reagent or other similar or related item, which includes an accessory or component that is . . . (b) is designed to diagnose or treat diseases or other ailments in humans or animals. (c) It is intended to modify the structure or function of the human body or animal. Therefore, in order to be considered a medical device , and therefore subject to FDA regulation, your program must satisfy one of two criteria:
- It must be intended to be used in diagnosing or treating the patient
- It should not be designed to change the structure or function of the body.
If the software you use is designed to be utilized by healthcare professionals to diagnose, treat, or manage patient information in hospitals or other healthcare facilities, the FDA is likely to consider the software to be medical devices and subject to review by the regulatory authorities.
Is Your Software a Medical Device?
According to FDA’s current oversight strategy, which considers the functionality of the software, rather than its device’s platform, FDA will apply its regulation only to medical devices that have capabilities that could 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 help those with psychiatric diagnoses (e.g., post-traumatic stress disorder (PTSD) or depression, anxiety, or obsessive compulsive disorder) maintain their behavioral coping skills by providing an “Skill of the day” method of behavior or audio messages that the user can use when they are experiencing an increase in anxiety;
- Software functions provide periodic reminders, motivational support, and educational information to those recovering from addiction or smokers trying to quit;
- Software functions that utilize GPS location data to warn asthmatics to environmental conditions that may cause asthma symptoms or warn an addict (substance abusers) when near a pre-identified high-risk or high-risk location.
- Software functions that employ video and video games to entice patients to perform their exercises in their own homes;
- Software functions that prompt the user to input which drug and herb they wish to take in conjunction and offer information about whether interactions have been observed in the literature, as well as a summary of what type of interaction was described;
- Software functions that consider patient characteristics, such as gender age, gender, as well as risk factors, to provide individual counseling, screening and preventive advice from established and highly-respected authorities.
- Software functions that use a checklist to determine typical symptoms and give information on when to visit an acupuncturist.
- Software functions that guide a user through a questionnaire of symptoms and signs in order to recommend the health facility that is most suitable for their needs.
- Mobile apps are designed to enable users to make a pre-determined nurse call or emergency call by using broadband or cell phone technology.
- Apps that permit caregivers or patients to communicate emergency alerts to first responders via mobile phones
- Software that tracks medication and offers user-configured reminders to help improve the medication adherence.
- Software functions that provide patients with access to their own health data for example, access to the information gathered during a prior visit to a doctor or historical trending and comparison of vital sign (e.g. body temperature or heart rate, blood pressure or respiratory rate);
- Software features that combine and show patterns of personal health events (e.g., hospitalization rates or alert notification rates);
- Software features allow users to electronically or manually enter blood pressure data, to send it to e-mail as well as track and track it, and then upload it to your personal or electronic health record.
- Mobile apps that offer dental health reminders, or tools to track users suffering from gum disease;
- Mobile apps offer patients suffering from prediabetes with advice or tools to assist them establish better eating habits or increase physical exercise;
- Applications that permit users to display images and other messages on mobile devices, which can be used by users of drugs who wish to quit addictive behaviors.
- Software functions that give information about safety and interactions with drugs (side effects and drug interactions active ingredient active ingredient) in an analysis based on demographic data (age and gender) and current diagnosis (current medication) and clinical data (current treatment).
- Software functions provide the surgeon with the list of suggested intraocular lens strengths and the recommended an axis for implantation based upon the information provided by the surgeon (e.g. an expected surgically-induced astigmatism that is likely to occur, patient’s axial length , corneal astigmatism prior to surgery, etc.)
- Mobile apps, typically software, converts a mobile platform into a medical device with a regulatory.
- Software that connects to a mobile platform using a sensor or a lead to monitor and display the electrical signals produced by the heart (electrocardiograph, ECG).
- Software that connects a sensor to the mobile platform or other tools within the platform, in order to monitor or record the eye movements in order to identify balance issues
- Software that gathers data about potential donors and transmits the information to an institution for blood collection. The software will determine if a donor is eligible to receive blood or other components.
- Software that can be connected to the device’s type in order to regulate its operation, function, or energy source.
- Software that modifies or disables the functions of an infusion pumps
- Software that regulates inflation or deflation of the blood pressure cuff
- Software is used to calibrate hearing devices and assess the electroacoustic frequency, sound intensity characteristics, and emanating 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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