GE Medical Systems Global Technology Company, LLC (Waukesha, WI)

A distributed medical diagnostic system is implemented by using one or more computers that execute at least one instance of a first medical diagnostic system software module and two or more computers that execute one or more instances of a second medical diagnostic system software module. The first and second diagnostic system software modules are members of a system software set (including many of these software modules for the system) that implements any chosen medical diagnostics system. To allow communication between system software modules at least one or more communications links are available.

The invention generally refers to medical diagnostic system, and more specifically to distributed software that may be used for diagnosing medical conditions.

Modern medical diagnostic equipment has long been accessible to doctors. Doctors utilize X-ray imaging and Magnetic Resonance Imaging to diagnose diseases and prevent illnesses. Medial diagnostic systems have grown more sophisticated and efficient over time. They are controlled by an advanced computer system that is embedded within the medical diagnostic system.

The computer system is accountable for numerous tasks. Not only must the computer system manage the hardware of the diagnostic system However, the computer system must also allow access to records of patients as well as archives of data (e.g., X-ray images), processreports, perform image processing, manage maintenance requests, and other similar tasks. The computer system functions as a single interface that allows for many functions essential for the proper operation of the diagnostic system.

In the past, the medical diagnostic system developers have implemented computers as a single, integrated system. This implies that the computer system is able to perform all the functions required to make a diagnostic system function.

There has been a long-standing need in the industry to have an open software architecture that can be used for medical diagnostic systems. This could solve the above problems and other issues.

The preferred implementation of this invention is a distributed medical diagnostic system. A distributed medical diagnostics set-up can be implemented by one computer that executes the first medical systemsoftware module and a separate computer which executes the second module of the medical system software. The system software and hardware sets which implement any medical diagnostic system include two modules: the first and second of medical diagnostic software. Also, the hardware and software that implement the same medical diagnostics system are spread among many computers. Both computers have an interface for communication. Both software modules communicate with one another via the communication interfaces.

The diagnostics system for medical use is preferably an ultrasound system , as explained in more detail below. As an additional example medical diagnostics, the system might also include a Magnetic Resonance Imaging system (MRI), X-ray imaging systems or a different kind of diagnostic device.

A further embodiment of the invention provides a method for creating a distributed medical diagnostic system. First, the method separates the medical diagnostic system’s system software into software modules. Next, themethod distributes the software modules among at least first and second computers, and connects the computers using communication interfaces. Furthermore, the procedure should be able to connect at minimum one of the first and secondcomputers to an electromechanical subsystem of the medical diagnostic system.

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What is a software medical device?

The FDA is referring to the functions of software that may comprise ” Software as a Medical Device” (SaMD), and “Software in Medical Device (SiMD) ), which is software that is part of (embedded inside) a medical device.

Section 201(h) of the Federal Food Drug and Cosmetic Act, ?21 U.S.C. 321(h)(1) defines the term “medical device” as instrument, apparatus, instrument or device, machine, implant an in vitro reagent or other similar or similar article, including an accessory or component, which is . . . (b) designed for use for the diagnosis of diseases or other conditions, or in the cure or treatment or prevention of diseases in animals or man, or (c) is designed to alter the structure or function of the human body or other animals.? To be classified as a medical device and therefore subject to FDA regulation, the software must meet the minimum of the following conditions:

  • It is essential to use it in diagnosing and treating patients.
  • It must not be designed to alter the structure or function of the body.

Thus, if your software is designed specifically for health professionals to diagnose and treat patients or in hospitals to manage patient records and patient information, the FDA is likely to view the programs as medical devices subject to review by regulators.

Is Your Software a Medical Device?

The FDA’s oversight currently, which looks at functional capabilities more than platforms, is designed to ensure that FDA regulates to only medical devices with functions that could pose the risk of compromising patient safety. Examples of Device Software and Mobile Medical Apps that FDA is focusing on includes

  • Software functions to aid patients suffering from diagnosed mental disorders (e.g. depression, anxiety, and post-traumatic stress disorder (PTSD) and others.) by providing “Skill of the Day” or a behavioral strategy or audio-based messages which the user can access when suffering from anxiety.
  • Software functions that provide regular reminders, motivational advice as well as educational information for patients recovering from addiction, or who are who are trying to quit.
  • Software functions that utilize GPS information about location to notify asthmatics to conditions in the environment which could trigger asthma symptoms or notify an addict (substance addicts) in proximity to a specified high-risk or high-risk location.
  • Software that uses games and video to help patients to take part in exercise at home.
  • Software functions that prompt a user to enter which herb and drug they wish to take in conjunction and offer information on whether interactions have been seen in the literature as well as an explanation of the kind of interaction was described;
  • Software functions that utilize the characteristics of the patient such as age, gender, and behavioral risk factors to offer specific screening for patients, counseling and preventive advice from well-known and reputable authorities;
  • Software functions that utilize an inventory of the most common signs and symptoms to provide a list of possible health conditions and advise on when it is appropriate to speak with a health care provider;
  • Software functions allow users to navigate through a questionnaire about their symptoms and then make a recommendation on the best medical facility to treat the patient.
  • Mobile apps are designed to enable users to make a pre-determined nurse call or emergency call using broadband or mobile phone technology;
  • Apps that let patients or their caregivers to send emergency notifications to first responders through mobile phones
  • Software functions keep track of medicines and give users user-configured reminders to help improve drug adherence
  • Software functions give users access to their health records. This includes historical trends and comparisons of vital indicators (e.g. body temperature, heart rate, or blood pressure).
  • Software features that combine and show patterns in health-related incidents that affect individuals (e.g., hospitalization rates or alert notification rates);
  • Software tools let users electronically or manually input blood pressure information, to share it with e-mail, track it and trend it, then upload it to an electronic or personal health record.
  • Mobile apps that allow for tracking and reminders of oral health. They also provide devices to monitor users who suffer from gum disease.
  • Mobile apps offer patients with prediabetes guidance or tools to assist them develop better eating habits or increase physical exercise
  • Mobile apps that show when appropriate images or other messages to a substance abuser who wants to get rid of addiction;
  • Software functions that report drug interaction and safety information (side reactions and interactions with drugs, active ingredient active ingredient) in reports based on information about demographics (age and gender) and current diagnosis (current medication) as well as clinical information (current treatments).
  • Software functions that permit the surgeon to identify the best intraocular lens powers for the patient and the direction of the implantation. This information is determined by the surgeon’s inputs (e.g. anticipated astigmatism induced by surgery and the patient’s axial length, prior to surgery cornea astigmatism, and so on.).
  • Mobile apps, usually software that converts a mobile platform to a regulated medical device.
  • Software that can be connected to a mobile platform with a sensor or lead to monitor and display the electrical signals generated by the heart (electrocardiograph, ECG).
  • Software that connects a sensor to the mobile platform or other tools within the platform, in order to monitor the eye movements, record and analyze eye movements to detect balance disorders
  • Software that asks potential donors about their history with donors and records and/or transmits those answers to a blood collection facility. This program determines if a donor is eligible to collect blood or any other component.
  • Software that can be connected to an existing device to control its operation function or energy source.
  • Software that alters the functions or settings of an infusion pump
  • Software that regulates the inflation and deflation of a blood pressure cuff
  • Software that adjusts hearing aids, and also evaluates the sound intensity characteristics as well as the electroacoustic frequency of hearing aids.

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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