What is a Software Medical Device for Computer-based software for automating administrative procedures in an office
The present invention is directed generally to the field of office automation, specifically to a computer-based method of automatizing administrative processes in a medical office. A computerized system that is integrated can handle administrative tasks that otherwise take a lot of manpower. In the end, significantly less labor is required for running a medical practice which reduces overhead costs.
It is widely known that staff is the most expensive expense in a medical practice. The majority of medical office labor is generated through the processing of documents. Physicians and staff in medical offices should be focusing their efforts on patient care, not document management. With the growing trend toward managed healthcare, which can lower medical costs, but will also add expenses for administrative work, the time that is spent is more important than ever.
Nowadays, there are hundreds of medical software apps. Most of them deal with billing, scheduling medical records, billing, and more recently, outcome management. Report generators are also available as well as online services. These tools can assist you move to an “paperless office.” Although these tools are helpful, none of them specifically address the biggest element of overhead for medical offices–labor hours.
Therefore, there is a need to reduce the number of people needed to perform office administration tasks typically required in medical offices, such as transcription on tape, preparation of charts, report generation, and forms generation. Embodiments of thepresent invention meet the requirements.
The invention is directed at an electronic system that can automate the administrative processes in medical practices. In accordance with an embodiment of the present invention, a computer-implemented method for automating administrativeprocedures in a medical office is provided. The method comprises steps of maintaining a database comprising patient information, information about the provider as well as information on document management; using the database to automatically generate management reports identifying the tasks to be performed on a specific day; automatically generating reports associated with the tasks to be completed, and populating the reports with relevant information taken from the database in the appropriate manner; and supporting off-site performance of one ormore administrative tasks that include managing electronic information exchanges with outside service providers.
According to a different embodiment of the present invention, the system comprises an control module that communicates with an administrator module, and an administration module for tapes, as well as an access to a database by the administrator module andthe tape management module. The tape management module may advantageously be set up to, for example, control outsourcing of tape transcription. In a variation on this model, a provider module is set up, for example to create reports that address the requirements of the service providers (e.g. daily task lists, workload reports, locations of charts and status of tape transcription as well as record review status and so on.) This system was designed to target the service providers instead of administrative personnel.
In accordance with another embodiment that is computer-implemented, a subscription service for automating administrative procedures in a medical office is provided. When providing a subscription service that is offered, one or more medical offices are supplied with an office automation system, which includes an interface for communications that allows the reception of data electronically. The service center gets the call from a medical office to provide office administration services, handles it, and then transmits data related to the procedure to the office automation system at the medical office. This service can include transcription on tape, preparation of charts and review of records, report generation, and forms generation.
The various examples will be discussed in greater detail later. People working who work in the field of medical services will be able to appreciate that the embodiments of this invention enable providers of medical services to simplify administrative processes in a manner that is not possible with previous medical software applications, allowing for significant reductions in administrative overhead due to staffing requirements.Click here to view the patent on USPTO website.
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What is a software medical device?
The FDA refers to functions in software that may comprise ” Software as a Medical Device” (SaMD) and “Software in a Medical Device (SiMD) ), which is software that is part of (embedded within) the medical device.
Section 201(h) of the Federal Food Drug and Cosmetic Act 21 U.S.C. 321(h)(1) defines a medical device as ?an instrument, apparatus, instrument an instrument, device implant, in vitro reagent, or other similar or related device, which may include accessories or components that is . . . (b) is intended for diagnosis or treatment of disease or other conditions in animals or humans. (c) is designed to modify the structure or function of the human body or animal. So, in order to qualify as a medical device and therefore subject to FDA regulation, your software must satisfy one of two requirements:
- It must be used in diagnosing and treating patients.
- It is not intended to alter the structure or perform any functions of the body.
Thus, if your software is specifically designed for health professionals to treat and diagnose patients or used in hospitals to manage patient information The FDA would likely view such programs as medical devices subject to regulatory review.
Is Your Software a Medical Device?
In accordance with FDA’s current oversight strategy that considers the function of the software higher than its platform, FDA will apply its supervision only to medical devices that have functionality that could cause harm to patient safety. Examples of Device Software and Mobile Medical Apps that FDA is focusing on include
- Software functions that help patients suffering from diagnosed psychiatric illnesses (e.g. post-traumatic stress disorder (PTSD) or depression, anxiety, obsessive compulsive disorder) keep their behavioral ability to cope by offering a “Skill of the day” method of behavior or audio-based messages the user may access during times of increased anxiety;
- Software functions that provide periodic educational updates, reminders, or motivational advice for smokers who are who are trying to quit, those recovering from addiction, or pregnant women;
- Software functions that utilize GPS location information to notify asthmatics to be in high-risk areas (substance users) or to warn asthmatics to possible environmental conditions that could cause symptoms.
- Software functions that make use of video and video games to encourage patients to perform their exercise routines at home;
- Software functions that ask users to select which herb and drug they wish to take simultaneously and give information on the likelihood of interactions being reported in the literature and an overview of the type of interaction was observed;
- Software functions that make use of the characteristics of the patient like age, gender and other risk factors for behavior to offer specific screening for patients, counseling and preventive recommendations from well-known and established authorities;
- Software functions that make use of a checklist to determine the most common signs and offer advice about when to see the doctor.
- Software functions that guide a user through a questionnaire of signs and symptoms in order to give a suggestion for the type of healthcare facility that is best suited to their requirements;
- Mobile apps are designed to enable users to make a pre-determined nurse call or emergency call by using broadband or cell phone technology;
- Mobile apps that enable a patient or caregiver to design and send an alert or general emergency notification to emergency responders.
- Software functions that track the use of medications and provide user-configured reminders for improved medication adherence;
- Software functions that provide patients with access to their own health information for example, access to data gathered at a previous visit to the doctor or historical trends and comparison of vital indicators (e.g., body temperature and blood pressure, heart rate or respiratory rate);
- Software features that combine and display patterns of personal health events (e.g. rate of hospitalization or alert notification);
- Software functions that allow the user to collect (electronically or manually input) blood pressure data , and transmit this information by email, track and analyze it, or add it to an electronic or personal health record.
- Mobile apps that provide oral health reminders and tracking tools for those suffering from gum disease;
- Apps that provide mobile access and other tools for patients with prediabetes;
- Apps that let users display messages and images on mobile devices. These apps could be utilized by users of drugs who wish to quit addictive behaviors.
- Software functions that provide information on safety and drug interactions (side effects and drug interactions, active ingredient, active ingredient) in reports based on the demographics (age and gender), current diagnosis (current medications) as well as clinical information (current treatment).
- Software functions allow surgeons to determine the best intraocular lens powers for the patient and the axis of implantation. This information is determined by the surgeon’s inputs (e.g., expected astigmatism caused by surgery, the patient’s axial length, preoperative corneal astigmatism etc.).
- Software, typically mobile apps which convert the mobile platform into medical devices that are regulated.
- Software that can be connected to mobile platforms with a sensor or lead to measure and display the electrical signals generated by the heart (electrocardiograph, ECG).
- Software that attaches sensors or other devices to the mobile platform so that it can view eye movements in order to identify balance problems.
- Software that gathers data about potential donors, and then transmits it to the blood collection facility. The software can determine if a donor is eligible to receive blood or any other component.
- Software that can be connected to the device’s type in order to regulate its operation, function, or energy source.
- Software that changes the settings or functions of an infusion pump.
- Software that regulates the inflation or deflation of a blood pressure cuff
- Software that calibrates hearing aids and assesses the sound intensity characteristics as well as 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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