IBEZA LLC (Coral Gables, FL)

A method of monitoring the outcome of a medical-related decision taken by a medical professional includes giving access to a variety of databases. Each database has medical information as well as rules which govern medical care. This method includes the receipt of medical analysis information from a physician. The information on medical analysis could be utilized by the medical professional to make the medical related decision. This could include applying at least one rule to medical analysis information from the doctor , and examining the medical-related decision made by the doctor to ensure compliance to the regulations. This method could also include notifying the medical professional of the compliance or non-compliance of the rules.

Software and systems have been widely used by medical professionals to identify ailments of patients and prescribe medical treatment.

For example, an example of a medical software system that is available under the trade name “ACORN” is a program created by the Accident & Emergency Department at Westminster Hospital in London that offers advice on managing chest pain patients in the emergency room. A second system that provides medical information is available under the tradename “ADE Monitor”. It is being developed by the Washington University School of Medicine Division of Medical Informatics. The system is designed to keep track of the clinical data of patients to detect potential adverse drug reactions. Another similar medical software system is offered under the brand designation “CADIAG-II” and has been created by the Department of Medical Computer Sciences, University ofVienna, the Department of Internal Medicine III, section of Rheumatology and the Department of Internal Medicine I, Divisions of Oncology, University of Vienna Medical School. This system is directed to colon diseases, and is a computer-assistedconsultation system to support the differential diagnostic process in internal medicine.

U.S. Published Patent Application No. 2002/0120471 was a recently published patent application. It describes a system to store numerous medical guidelines for different health conditions as well as historical information data for a variety of patients. The information about the patient is collected via a global communication network, i.e., the Internet and analyzed to provide a patient specific risk report based upon the medical guidelines contained within the database. A physician’s treatment plan can be developed to decrease risk for patients based on medical guidelines.

This method, however, may be disadvantageous as it permits a doctor to be dependent on an established system, rather than the doctor’s own knowledge of medicine. Additionally, the system fails to evaluate the medical performance regarding whether the medical treatment prescribed by the physician is correct. This could result in the loss of resources.

U.S. Published Patent Application No. 2002/0143579 of Docherty and co. discloses a system that identifies the potential for direct intervention by physicians to improve the quality of prescriptions and the patient’s compliance. The system collects information about a physician’s practice and then analyzes it with regard to expert guidelines. The system identifies any deviations from guidelines, and gives the doctor details for intervention.

U.S. Pat. discloses an assessment system for the performance of physicians, that includes a database that records patient/physician contact. No. No. 5,924,073 for Tyuluman and others. An evaluator is coupled to the database to evaluate the data using statisticalanalysis. The system is able to determine the standard of care that covers a specific patient group. The standards of care can be revised in light of more efficient and more effective treatments, and the system may identify doctors who performoutside the prescribed standards of care. However, these systems do not consider the several standards that physicians must look at when prescribing medical treatment, i.e., hospital standards, medical standards, insurance standards, etc.

U.S. Published Patent Application No. 2003/0055679 by Soll and co. provides a computerized management of patients system which includes an individual module for patients as well as a physician module and a database. Patients can input their patient information in the patient module. The database includes information about medical assessment and treatment used to analyze the patient’s data and produce an assessment report. The physician may edit the report and add assessments and management plans. The physician can also decide on the patient education materials to be handed out to the patient during an interview. This system relies heavily on the patients capacity to accurately input their patient information.Further the system gives the ability to people who don’t have as much medical expertise as a qualified medical professional.

With regard to the above background, it is therefore the purpose of the present invention to provide an apparatus that improves the quality of the patient’s health by reducing medical errors. It is also an objective of the present invention to create a system that monitors medical care that patients receive as well as the performance of medical professionals to provide enhanced healthcare services through reducing the possibility of medical mistakes. The other goal of the invention to monitor and report on the outcomes of medical procedures. The invention also seeks to enhance the effectiveness of medical charts review and reduce the time required to pay for treatment. Another purpose of the invention is to offer secure indexing and search functions that permit quick access to information about patients.

It is further an object of the present invention is to provide an instrument that significantly reduces the time for an insurance company to make the payment to a physician. There is a further object of the present invention to provide updatedmedical treatment information, such as new medical standards and procedures for medical professionals. Another object of this invention is to reduce medical resource waste.

These and other items as well as features and benefits according to the invention described herein are made available by a monitoring system for medical professionals system that includes user interfaces that communicate with a global communications network that can be used by a medical professional. The system could also comprise databases for patient information as well as a diagnosis database and a medical treatment database each of which could be in contact with the world’s largest communications network.

The patient information database may contain information about a range of patients associated with the medical professional. The medical treatment database could include information that is accessible to medical professionals.

The system may also contain an internet-connected server that is connected to the global communication network. A recording system could be integrated into the server to records of medical procedures selected by the physician. The recording system may monitor the medical procedures selected by the medical professional to ensure compliance with a predetermined standard selected from a plurality of standards that have been established. The record system aids in the training of medical professionals. This, in turn, improves patient care by reducing medical mistakes.

The system may further include the standards database that communicates with the global network of communications. The standards database can include a number of standards that have been predetermined and could be regularly updated. The plurality of predeterminedstandards may, for example, be hospital standards, insurance standards, medical treatment standards, pharmaceutical standards, medical office standards, or emergency response standards. The system is able to integrate practice guidelines from a variety of sources such as insurance and federal programs hospitals, medical facilities, medical practices and specialists.

The patient information as well as medical diagnosis databases are also able to be updated. The databases are able to be updated to provide doctors with the most current medical data and improves the standard of medical care.

A reporting system could be part of the system to report the physician who has chosen any treatment that is not conforming to at least one standard that is predetermined in the standards database. A reporting agency may be notified when a physician has been found to have selected the wrong treatment, which isn’t conforming to any of the standards that have been predetermined. This reporting system can be enhanced in order to permit the system to be monitored by doctors who use medical procedures which aren’t in line with predetermined standards. The medical professionals could receive training recommendations from the monitoring system.

The system could further comprise the identification of medical professionals for identifying the medical professionals that access the databases. The system may also include a notification system in communication with the global communicationsnetwork for notifying an insurance company of patient treatment. This notification system could help to reduce the time it takes doctors to be paid by their insurance companies for treatments they’ve prescribed.

A medical professional can be, for example an ophthalmologist, a physician assistant or a nurse. This method can be utilized by any medical professional who has contact with patients.

The method described in the invention described herein is for monitoring a medical professional. This could include giving medical professionals access to the patient information database and the diagnosis database, as well as the medical treatmentdatabase. The method could also involve checking the treatment chosen by the physician for compliance with at least one predetermined standard selected from a variety of standards that have been predetermined on the predetermined standardsdatabase.

Another feature of the invention discussed above is selecting a treatment for medical use. The method can include accessing and updating the patient information of a patient who is registered in the patient information database and then accessing the diagnosis information in a diagnosis database and then selecting a medical treatment for the patient in accordance with the information on the diagnosis in the database for diagnosis. The method may also involve the evaluation of the chosen medical treatment in relation to an existing medical treatment.

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What is a software medical device?

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

Section 201(h),?21 U.S.C. 321(h)(1) defines the term “medical device” as instrument, apparatus, implement or device, machine implant or in vitro reagent or other similar or related item, which includes a component or accessory, which is . . . (b) is designed to diagnose or treat disease or other conditions in animals or humans. (c) is designed to alter the structure or functions of human bodies or animals. Therefore, in order to be considered a medical device , and consequently subject to FDA regulations, your software must satisfy one of two requirements:

  • It should be designed to be used to diagnose or treat a patient; or
  • It must be intended to modify the structure or functions of the body.

If your software is designed to be used by health professionals to diagnose, treat or manage patient records in hospitals and other medical facilities, the FDA will likely view such 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 that considers the function of the software higher than its device’s platform, FDA will apply its regulatory oversight only to devices for medical use that possess functions that cause harm to the safety of patients. Some examples of Device Software and Mobile Medical Apps FDA is focused on

  • Software functions that help those suffering from mental illness (e.g. anxiety, depression, post-traumatic stress disorder (PTSD) for instance.) by offering “Skill of the Day”, a behavioral technique, or audio messages, that the user can access when feeling anxious.
  • Software functions that provide regular reminders, motivational guidance as well as educational information for patients recovering from addiction or smokers looking to quit;
  • Software functions that use GPS location information to notify asthmatics when they’re close to high-risk areas (substance users) or to warn them of potential environment-related conditions that could trigger symptoms.
  • Software functions that employ video and video games to entice patients to do their physical therapy exercises at home;
  • Software functions that let users choose the medication or herb they would like to use at the same time. They also provide details on interactions and provide an overview of the type of interaction reported.
  • Software functions that consider specific characteristics of patients, such as gender age, gender, as well as risk factors, to provide specific counseling, screening and preventive advice from well-known and respected authorities.
  • Software functions that make use of a checklist to identify the most common signs and offer advice about when to see an acupuncturist.
  • Software functions that help users through the questionnaire of symptoms and signs to give an indication of the kind of health care facility most appropriate to their needs;
  • Mobile applications are intended to enable users to initiate a pre-specified nurse call or emergency call by using broadband or cell phone technology;
  • Apps that allow caregivers or patients to send emergency notifications to first responders via mobile phones
  • Software that tracks medication and offers user-configured reminders to increase medication adherence.
  • Software functions allow users access to their health information. This includes historical trending and comparisons of vital indicators (e.g. body temperature and heart rate pressure).
  • Software features that combine and display patterns in health-related incidents that affect individuals (e.g. hospitalization rates or alert notifications rates);
  • Software functions allow users to gather (electronically or manually entered) blood pressure data and transmit this data via email, track and trend it, or even upload it into a personal or electronic health record;
  • Apps that offer mobile apps to track and remind users about oral health or devices to monitor users suffering from gum disease.
  • Apps that give mobile users access to information and other tools for patients with prediabetes;
  • Mobile apps that show at the right time, images or other messages to a user of a substance who is looking to end their addiction;
  • Software functions that report interactions between drugs and other medications as well as relevant information on safety (side effects and drug interactions, active ingredient) in a form of a report, based on demographic data (age, gender), medical information (current diagnosis) and the current medication and
  • Software functions that provide the surgeon with an inventory of intraocular lens power and suggested the axis of implantation, based on information provided by the surgeon (e.g., predicted surgically induced astigmatism length of the patient’s axial and cornea astigmatism preoperatively etc.)
  • Software, mostly mobile apps transforms mobile platforms into a medical device that can be regulated.
  • Software that can be connected to mobile platforms with a sensor or lead to monitor and display the electrical signals generated by the heart (electrocardiograph, ECG).
  • Software that connects sensors or other instruments to the mobile platform so that it can monitor and record eye movements to diagnose balance disorders
  • Software that collects data about potential donors and sends the information to the blood collection facility. This program determines the eligibility of a potential donor to collect blood or any other component.
  • Software that connects to an existing device type for control of the device’s operation, function or energy source.
  • Software that alters or deactivates the functions of an infusion pump.
  • Software that regulates inflation or deflation of the blood pressure cuff
  • Software that is used to calibrate hearing aids and to evaluate the electroacoustic frequencyand audio intensity characteristics, as well as emanating from hearing aids master hearing aids, group hearing aids, or auditory trainers for 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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