Medunity Inc. (East Sandwich, MA)
What is a Software Medical Device for Referral system
Is Your Software a Medical Device for Referral system
The United States has a gatekeeper medical insurance system. This is a model under which the member is required to select a primary care physician (PCP) who will then provide or authorizes all care for that particular member. If a member is required to visit an expert provider, such as dermatologist or cardiologist, must first obtain an appointment with a physician from the PCP. A failure to comply with this rule usually results in a denial of coverage for the specialist visit. In mostinstances, the member (hereinafter referred to as the “patient”) cannot schedule an appointment with the specialist without having an authorization and accepted referral request.
The PCP is usually a general physician, and is accountable for determining whether the patient needs a specialist. Therefore, the PCP has to either conduct an office exam of the patient or at least review the patient’s medical records prior to making the request for referral. The PCP sends the request for referral to the insurance company for the patient to seek approval. The referral request is approved by the insurance company and the PCP forwards it to the office of the specialist. Before the patient can make an appointment to see the doctor, all of these transactions have to be done. There is a significant gap in time that could occur between the patient’s initial need until the time when the patient sees the specialist.
Referral request systems have been further complicated by the 1996 adoption of the Health Insurance Portability and Accountability Act, (HIPAA), by Congress. HIPAA creates strict standards for the protection of confidential patient data. Health care providers are legally responsible to adhere to these strict standards. A majority of medical facilities are no longer sending referrals by fax or email. Instead, they send hardcopies of the referrals to the offices of the recipients and verify the receipt by calling. Apart from creating a massive amount of paperwork, such transactions also contribute to delays, a reduction in efficiency and productivity, and increased financial burdens on health professionals. Moreover, constantmailing of documents between the various offices invariably results in information that is lost in transaction.
The initial referral request does NOT give an unlimited access to the specialist. If the patient needs additional visits to the specialist which are not listed in the original referral request then she has to submit an updated treatment plan to her PCP. The patient is then faced with the burden of continuously asking about the status of the referral (e.g. whether the timeframe has been lapsed or if the number of visits have was exceeded) each time she schedules a new appointment with the office of a specialist.
The present invention provides methods and apparatus, which include computer program products, for electronic patient referral.
The application is directed in general to a procedure that involves the submission of a referral request to one provider, accepting the request by another provider and obtaining insurance approval for the request for referral and then import a medical file for patients via an external database. Exporting the medical records to the external system, updating the file with diagnostic data and updating a status regarding thereferral requests.
A computer program which is tangible is another aspect. The computer program product is operable to cause an apparatus for data processing in a network of interconnected computers, to submit an request for a referral by a first provider, then accept the referral request of a second provider, obtain an insurance authorization of the referral request to import a medical file for a patient using an external system, export the imported medical record to an external system,update the medical record with diagnostic data, and change the report on the status of the request.
Another aspect is an apparatus which includes in an interconnected network of computers the means to submit an inquiry for referral from a first provider. The apparatus is equipped to accept a referral request made by an additional provider, means to receive an insurance authorization that is in line to the referral request means to import medical records from an external system, and export to the external system, as well as the ability to obtain diagnostic information from the second provider , and to update a referral request status. This information is used for making changes to the medical record.
Any of the above features might comprise one or more of the following characteristics. In one instance, the network of interconnected computers includes a server system. The server system stores the referral request form as well as the referral data form.
Another approach involves the health care provider as the primary provider. In another case the first provider is the patient that submits the referral request to the first or second provider. In yet anotherimplementation, the second provider includes a health care provider.
One provider accepts the referral request, monitoring the network with the second person, sending an acknowledgement of the referral request, placing the patient on a wait-list, providing an appointment for the patient, and then examining the patient by the second doctor.
Another method is to incorporate the patient’s medical history. The medical history data includes personal medical information, family information, and social information. One implementationimports and exports the medical record by entering the medical history information manually. Another method imports the medical records and exports them after connecting the medical history data with an external system. Still anotherimplementation imports and exports using an application programming interface (API). Another method is to import and export the medical records using a paste and post method. Paste and post is the process of selecting medical record from an external system, copying the information, pasting it onto the clipboard, and then linking it to various fields in the external system. Finally, a number of fields are filled in with the corresponding medical information.
A diagnosis is a brief summary of the patient’s office examination as well as the results of laboratory tests, and a record containing the prescribed medication by the second physician. Another method is to send the revised referral request to the first provider.
In one instance the first or second provider performs an update on the condition of the referral request. The status of the referral request is a sign that the patient was seen by the second provider. The status can be further filtered and sorted by a category.
In the next drawings and in the description, the details of some of the characteristics of the invention may be discovered. Other features, objects and advantages of the invention will become obvious in the description and drawings and also from the claims.
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What is a software medical device?
The FDA refers to functions in software that can include ” Software as a Medical Device” (SaMD) as well as “Software in a Medical Device (SiMD) ), which is software that is part of (embedded in) a medical device.
Section 201(h) of the Federal Food Drug, Cosmetic, and Act, 21 U.S.C. 321(h)(1) defines the term “medical device” as instrument, apparatus, device or device, contrivance, implant an in vitro reagent or other similar or related item, which includes accessories or components that is . . . (b) is designed for diagnosis or treatment of diseases or other ailments in animals or humans. (c) is designed to alter the structure or function of human bodies or animals. So, to be classified as a medical device and thus subject to FDA regulation, your software must satisfy two requirements:
- It must be used in diagnosing and treating patients.
- It should not be designed to change the structure or function of the body.
If your software is designed to be utilized by healthcare professionals to diagnose, treat or manage patient records in hospitals and other medical facilities, the FDA will likely consider such software as medical devices subject to regulatory review.
Is Your Software a Medical Device?
As per FDA’s current oversight strategy, which considers the functionality of the software higher than its platform, FDA will apply its regulatory oversight only to devices for medical use that possess functionality that could pose a danger to patient safety. Examples of Device Software and Mobile Medical Apps that FDA is looking at include
- Software functions to aid patients with diagnosed mental disorders (e.g. depression, anxiety, and post-traumatic stress disorder (PTSD) and others.) through the use of “Skill of the Day” or a behavioral strategy or audio message that the user can access when they are suffering from anxiety.
- Software functions that provide periodic educational updates, reminders, or motivational advice for smokers who are trying to quit, patients recovering from addiction, and pregnant women;
- Software functions that make use of GPS location data to warn asthmatics of environmental conditions that could trigger asthma symptoms or warn an addict (substance abusers) whenever they are near a designated high-risk or high-risk location.
- Software that uses games and video to help people to do their take part in exercise at home.
- Software functions which allow users to select which medication or herb they would like to consume simultaneously. They also provide information about interactions , and provide an overview of the type of interaction reported.
- Software functions that are able to take into consideration the characteristics of patients, like gender, age, and risk factors, in order to provide specific counseling, screening and prevention advice from well-established and highly-respected authorities.
- Software functions that make use of an inventory of typical symptoms and signs to provide information on when to visit a doctor and what you should do next.
- Software functions that help users to complete a questionnaire about their symptoms and then provide a recommendation of the best health care facility for them.
- The mobile apps enable users to make nurse calls or emergency calls using broadband or cell phone technology.
- Mobile apps that allow a patient or caregiver to create and send an alarm or general emergency alert to first responders;
- Software functions that track the use of medicines and give users user-defined reminders for improved drug adherence
- Software functions that offer patients with a way to access their personal health records including access to data gathered during a previous clinical visit or historical trends and comparison of vital sign (e.g. body temperature and blood pressure, heart rate or respiration rate);
- Software functions that show patterns in personal health incidents (e.g. rate of hospitalization or alert notification rate)
- Software functions that allow a user to collect (electronically or manually entered) blood pressure information and transmit this information by an e-mail, monitor and track it, or upload it to a personal or electronic health record;
- Mobile apps that offer oral health reminders or tools to track users suffering from gum disease.
- Apps that provide mobile access and tools for prediabetes patients;
- Mobile apps that display at the right time, images or other messages for those who abuse substances and want to end their addiction;
- Software functions that provide drug interaction and safety information (side effects and interactions between drugs active ingredient, active ingredient) in a report based upon demographic data (age and gender), current diagnosis (current medications) as well as clinical information (current treatments).
- Software functions enable surgeons to identify the optimal intraocular lens strength for the patient, and the ideal axis for implant based on the information given by him (e.g. the expected surgically-induced astigmatism, the length of the patient’s axial, cornea astigmatism, etc.).
- Software, typically mobile apps, that converts a mobile platform to a regulated medical device.
- Software that is connected to an mobile platform using an instrument or lead to display and measure electrical signals coming from the heart (electrocardiograph; ECG).
- Software that attaches a sensor to the mobile platform, or other tools within the platform, in order to monitor or record the eye movements to identify balance issues
- Software that asks potential donors about their history as donors and their records and/or sends those answers to an institution for blood collection. The software will determine whether a person is eligible to donate blood or any other component.
- Software that connects with an existing device to regulate its operation, function or energy source.
- Software that changes the settings or function of an infusion pump
- Software that regulates the deflation or inflation of the blood pressure cuff
- Software that calibrates hearing devices and assesses the sound intensity characteristics and electroacoustic frequencies of master hearing aids, and group 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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