Rocoview, Inc. (Bellaire, TX)

A keyboard for computers designed to ease and facilitate the user’s interaction with software for medical use. It comes with color-coded key groups and function specific icons. A key group is utilized to display medical images like the display of Computed Tomography scans, Magnetic Ressonance Imaging scans (MRI scans) and ultrasound scans of different parts of the body of a patient. Another key group is associated with medical image navigation tasks such as switching towards the next, prior, or last image in an image group. Every key in each key group has a function-specific indicator that indicates the key’s purpose in a particular medical software program. A key group connected to radiographic image acquisition may include keys with icons and/or text that represent predetermined body regions, such as the neck and head, liver, brain, stomach lung and liver, knees, bone, ankle, and mediastium.

The invention is generally applicable to keyboards that are used in computer systems, and more specifically keyboards that are utilized in computers that run medical programs applications.

Computer systems are now being utilized in more applications as computer processing capabilities and user-interface technology have improved. For example, doctors use computers to analyse and display medical information.

Conventional medical imaging systems consist of an imaging device that is connected to one or more workstations and one or more server computers through the computer network. Workstations run applications that allow users to look at as well as navigate through the medical images generated by the device. Illustrative imaging devices comprise Computed Tomography (CT), Magnetic Resonance Imaging (MRI) ultrasound, and X-ray scanners. During evaluation, images acquired are displayed on the monitor of the workstation and can be controlled using input devices like an electronic keyboard or pointer device.

The typical medical software applications (e.g. radiographic and cardiology software applications) comprise a wide array of functions a physician may utilize to show, manipulate, and evaluate taken images. These functions typically provide fornot only the adjustment and analysis of the images themselves as well as navigation between the images, sorting the images, grouping of images, access to associated patient information as well as various functions for dictation.

Referring to FIG. 1, current medical software applications use traditional keyboards, such as the keyboard 100 for user input. These keyboards require the user/interpreter to remember specific functions that are associated with certain keys, or write the keys down on strips of paper. Then, he/she will use a key-code sheet frequently or “hunt-and?peck” until they’re correct. It is common that, for instance, functionkeys 105 (F1 through F15) along with other key groups (e.g. key groups 110 through 135) are programmatically assigned functions by the medical software application (either through default or user action). It is difficult for physicians to utilize the medical software app effectively because of the huge variety of keys and functions. It is advantageous to possess a keyboard that makes it easier for users to access medical software.

The invention includes an instrument for use with medical software application programs. An illustration medical software program is comprised of the ones used in radiology, orthopedic, and dental. Oneembodiment has two key groups. The first group contains keys that are adorned with icons which represent the display of medical images. The second group includes keys that display medical image navigation functions. Oneembodiment keys have icons that represent predetermined body regions. When they are activated, the images shown are optimized to fit the body part which the icon for the key is.

A third visually distinct key group that contains keys associated with manipulating medical images is also included in another embodiment. A fourth visually distinct key group, which includes keys associated with retrieval and modification of information about patients is also included in another embodiment.

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What is a software medical device?

The FDA may refer to the functions of software that comprise ” Software As a Medical Device” and “Software in a Medical Device(SiMD)”, which are software that is integral (embedded within) a medical device.

Section 201(h),?21 U.S.C. 321(h),(1) defines a medical device to be?an apparatus, implements that are a machine, a contrivance, implant, in vitro-reagent, or other similar or related articles, including a component, that is. . . (b) is designed to detect the presence of disease or other ailments or treat, ameliorate, treat, or prevent these. (c) has the possibility of altering the structure or function of the body of animals. Therefore, in order to be considered a medical device and therefore subject to FDA regulations, your software must meet one of two requirements:

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

If your software is designed to be used by healthcare professionals to diagnose treat or manage patient records in hospitals or other healthcare facilities, the FDA is likely to consider the software to be medical devices subject to review under the regulations.

Is Your Software a Medical Device?

In accordance with FDA’s current approach to oversight, which considers the functionality of the software more than its platform, FDA will apply its regulation only to medical devices that have capabilities that could be a risk to the safety of patients. Examples of Device Software and Mobile Medical Apps that FDA is focusing on includes

  • Software functions that aid patients with diagnosed psychiatric conditions (e.g. the post-traumatic stress disorder (PTSD) or anxiety, depression, obsessive compulsive disorder) maintain their behavioral strategies for coping by providing the “Skill of the Day” behavior technique or audio-based messages users can use when they are experiencing an increase in anxiety;
  • Software functions provide regular education information, reminders or motivational advice for smokers who are trying to quit, addicts who are recovering from addiction or pregnancies women;
  • Software functions that make use of GPS location information to alert asthmatics to environmental conditions that may cause asthma symptoms, or to notify an addict (substance abusers) in proximity to a specified high-risk or high-risk location.
  • Software that utilizes games and video to help patients to exercise at home.
  • Software functions that allow users to select which herb or drug they wish to consume simultaneously. They also provide details about interactions , and give a summary of the type of interaction reported.
  • Software functions that use patient characteristics like age, sex, and behavioral risk factors to provide patient-specific screening as well as preventive counseling from well-known, established experts;
  • Software functions that utilize an inventory of typical symptoms and symptoms to provide guidance on when it is appropriate to see a doctor and what to do next.
  • Software functions guide the user through a checklist of symptoms and signs to provide a recommendation for the type of health care facility most appropriate to their needs;
  • Mobile apps are designed to allow a user to initiate a pre-specified nurse call or emergency call using broadband or cellular phone technology.
  • Apps that allow patients or caregivers to send emergency notifications to first responders via mobile phones
  • Software functions keep track of medicines and give users user-configured reminders to ensure better drug adherence
  • Software functions that give patients access to their health records. This includes historical trends and comparisons of vital indicators (e.g. body temperature, heart rate , blood pressure).
  • Software functions that aggregate and display trends in personal health incidents (e.g., hospitalization rates or alert notification rates);
  • Software features permit users to either manually or electronically enter blood pressure data, and to share it with e-mail, track it and trend it, and then upload it into your personal or electronic health record.
  • Apps that provide mobile applications to track and remind users regarding oral health, or tools for tracking users suffering from gum disease.
  • Mobile apps offer patients suffering from prediabetes with advice or tools to assist them develop better eating habits or increase physical activity;
  • Mobile applications that display when appropriate pictures or other messages to an addict who is trying to get rid of addiction;
  • Software functions that report drug-drug interactions as well as pertinent safety information (side effects and drug interactions active ingredient) as a report , based on demographic information (age and gender) and medical data (current diagnosis), and current medications; and
  • Software functions that permit surgeons to determine the best intraocular lens powers for the patient as well as the most effective axis of implant based on the information supplied by the surgeon (e.g., expected surgically induced astigmatism and patient’s axial length, preoperative cornea astigmatism, etc.).
  • Applications, mostly mobile which transforms mobile platforms into an approved medical device.
  • Software that communicates with a mobile platform via the use of a lead or sensor to monitor and display electrical signals generated by the heart (electrocardiograph; ECG).
  • Software that connects a sensor to the mobile platform, or any other tool within the platform, that allow users to see, record, and analyze eye movements to identify balance issues
  • Software that inquires about their donor history and records and/or transmits those answers to a blood collection facility. This software is used to determine whether a donor is eligible before collecting blood or other components.
  • Software that is connected to an existing device type in order to regulate its function, operation, or energy source.
  • Software that alters the settings or functions of an infusion pump
  • Software that regulates inflation or deflation of the blood pressure cuff
  • Software is used to calibrate hearing devices and evaluate the electroacoustic frequencies, audio intensity characteristics, as well as coming from hearing aids master hearing aids, group hearing aids, or group auditory trainers.

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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