IBEZA LLC (Coral Gables, FL)

One way to determine the degree of compliance with a medical decision might be to get medical data related to the medical-related decision and apply at the very least one rule. This could also mean reviewing the medical related decision to ensure that it is in compliance with at least one rule and providing outcomes from the audit.

Systems and various types of software have been widely utilized to aid medical professionals in the diagnosis of patient conditions, and to aid doctors in prescribing specific medical treatments for thosediagnoses.

For instance, one example is a medical software system available under the trade name “ACORN” is a software which was designed by the Accident and Emergency Department of Westminster Hospital in London that provides advice on the management of chest pain patients in the emergency room. Another medical software system is available under the tradename “ADE Monitor”. It is currently being developed at the Washington University School of Medicine, Division of Medical Informatics. The system was designed to track patient data for potential adverse drug events. Yet another like medical software system is offered under the trade 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 is a patent application. It describes a method that stores numerous medical guidelines, and also historical of patients. The patient information are collected via an international communication network (i.e. the Internet and then analyzed to produce a specific risk assessment, based on medical guidelines which are stored in the database. Based on the guidelines of medical professionals the doctor may develop a treatment plan to reduce patient risk.

This method, however, could be detrimental as it permits a doctor to be dependent on a system, instead of the doctor’s personal medical knowledge. Furthermore, the system is unable to monitor medical performance in relation to whether the medication prescribed by the physician is proper. This could lead to an inability to use resources.

U.S. Published Patent Application No. 2002/0143579, Docherty and al. provides a method to identify opportunities for direct physician intervention to enhance prescribing practices and ensure compliance of patients. The system collects information about the practice of a physician and analyzes it with regard to professional guidelines. The system identifies deviations from the guidelines of experts and gives the doctor the information needed to make an intervention.

A method of evaluating physician performance that includes a database to store physician/patient contact information is described in U.S. Pat. No. No. 5,924,073 to Tyuluman and co. To evaluate the data using statistical analysis, an evaluation tool is attached to the database. This system may be used to define a standard of care for an essential segment of the patient population. This method can be utilized to improve the standard of care to reflect better and more efficient treatment options. The system may additionally identify doctors that do not meet the standard of care established. These systems, however, do not take into account the many standards physicians must look at when prescribing medical procedures, i.e., hospital standards or insurance standards, medical standards, etc.

U.S. Published Patent Application No. 2003/0055679 filed by Soll and co. A computerized system for managing patients comprising an individual patient module as well as a physician module, is described by Soll and colleagues. The system lets patients input their patientinformation into the patient module. The database includes information about medical assessment and treatment which is used to create reports. The report can be edited by the physician to include management and assessment plans. The doctor can also decide on educational materials to give to the patient together with a health-related summery during a consultation with the patient. The system relies heavily on the patients capacity to accurately input their patient information.Further the system gives access to those who do not have the same information about medicine as a medical professional.

With regard to the above background, it is the goal of this invention to create an apparatus that improves the quality of the patient’s health by reducing medical errors. The invention also seeks to create an instrument that monitors the medical care patients receive as well as the medical professionals to improve the quality of healthcare and decrease medical errors. It is further an object of the present invention to track and report theoutcomes of medical procedures. Further, it is an objective of the invention to create a system that improves the efficiency of medical record review and to speed up the process of receiving payments for medical services and treatments. It is yet anotherobject of the present invention to provide secured indexing and search capabilities to ensure that patient information may be readily located.

Further, it is a primary goal of this invention to provide an apparatus that drastically reduces the time for an insurance company to make payment to a medical professional. The present invention also aims to give medical professionals current medical treatment information like the most recent medical standards and procedures. It is another goal of the present invention to minimize any wasted medical resources.

These and other objects as well as features and benefits that are in line with the invention described herein are provided by a medical professional monitoring system that includes a user interface in communication with a global communications network to be used by medical professionals. The system could also comprise databases for patient information and a diagnosis database and a medical treatment database each of which could be in communication with the world’s largest communications network.

The patient information database could contain information on a variety of patients who are associated with a medical professional. The diagnosis database could contain diagnosis information accessible by the medical professional, andthe medical treatment database might contain medical treatment information that is accessible to the medical professional.

A server can be included in the system that communicates with the global communications network. A recording system may be integrated into the server to keep records of medical procedures that are prescribed by the doctor. Medical professionals can make use of the system for recording to track their medical procedures to make sure that they are complying with a specified standard. The record system benefits the education of medical professionals. This will improve the patient’s care by reducing medical errors.

The system can also comprise the standards database that communicates with the global network of communications. The database for standards could include a number of predetermined standards that can be constantly 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. In this way, the system could advantageously coordinate practiceguidelines from several sources, such as insurance and federal programs hospitals, medical facilities, medical practices and medical professionals.

The patient information diagnostic and medical treatment databases can also be updated. These databases can be updated to provide doctors with the most current medical information and improves the standard of medical treatment.

A reporting system can be part of the system to inform any physician who chooses to use an option that isn’t conforming to at least one of the standards in the standards database. A reporting agency may be notified if the medicalprofessional chooses a treatment that is not conforming to any of the standards that have been predetermined. This reporting system can be improved to enable the system to track medical practitioners who choose treatments that are not in accordance to predetermined standards. The monitoring system can also suggest training for these medical experts.

The system could also include a medical professional identification device to identify the doctors who access databases. The system may also include a notification system in communication with the global communicationsnetwork for notifying an insurance company of patient treatment. This system of notification could assist in reducing the time it takes for doctors to be paid by their insurance companies for treatment they’ve ordered.

The medical professional may, for example, be an ophthalmologist, physician assistant, a nurse, a pharmacist, a dietician, a laboratory technician, or even an emergency response worker. This method can be utilized by anyone in the medical field who is in contacts with patients.

Monitoring a physician is a component of the invention. This may include granting the medical professional access the patient database, the diagnosis database, as and the medical treatment database. Monitoring the treatment selected by the medical professional to ensure that it is in compliance with the minimum predetermined standard of the variety of norms predetermined within the predetermined database could be part of the method.

Another method aspect of the invention described herein is for selecting a treatment for medical use. The method may comprise accessing and updating information about a patient of a patient who is registered in an information database for patients and then accessing the diagnosis information in a diagnosis database and deciding on the appropriate medical treatment for the patient in accordance with the diagnosis information contained in the diagnosis database. The method could also include checking the chosen treatment for conflict with existing medical treatments.

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What is a software medical device?

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

Section 201(h) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 321(h)(1) defines an medical device as instrument, apparatus, instrument, machine, contrivance implant an in vitro reagent or any similar or similar article, including an accessory or component that is . . . (b) is intended to treat or diagnose diseases or other ailments in humans or animals. (c) Is intended to alter the structure or function of animals or human bodies. To be classified as a medical device and therefore subject to FDA regulations the software must satisfy at minimum one of these requirements:

  • It is essential to use it in the diagnosis and treatment of patients.
  • It must be intended to alter the structure or perform any function of the body

If the software you use is designed to be utilized by healthcare professionals to diagnose, treat or manage patient data in hospitals or other healthcare facilities, the FDA will likely view such software to be medical devices that are subject to review by the regulatory authorities.

Is Your Software a Medical Device?

FDA’s current oversight, which looks at functional capabilities more than platforms, is designed to ensure that FDA applies its regulatory oversight to only medical devices with functions that could pose a risk to patient safety. Some examples of Device Software and Mobile Medical Apps FDA is focusing on

  • Software functions to aid patients suffering from diagnosed mental disorders (e.g. anxiety, depression, post-traumatic stress disorder (PTSD) for instance.) through the use of “Skill of the Day” or a behavioral strategy or audio message that the user is able to access when experiencing anxiety.
  • Software functions provide periodic reminders, motivational guidance, and educational information to those recovering from addiction or smokers who want to quit.
  • Software functions that make use of GPS location information to notify asthmatics to environmental conditions which could trigger asthma symptoms or alert an addiction patient (substance users) whenever they are near a designated high-risk or high-risk location.
  • Software that makes use of games and video to help people to do their take part in exercise at home.
  • Software functions prompt users to choose which medicine or substance they want to take at the same time. They also provide information about interactions , and provide a summary of the type of interaction that was reported.
  • Software functions that take into account the characteristics of patients, like gender age, gender, as well as risk factors, to offer patient-specific counseling, screening, and prevention advice from well-established and well-respected experts.
  • Software functions that utilize an inventory of typical symptoms and signs to give guidance on when it is appropriate to see a doctor and what next.
  • Software functions allow users to complete a questionnaire regarding symptoms and provide a recommendation of the best health care facility for the patient.
  • Mobile applications are designed to let users initiate a nurse call or emergency call using broadband or mobile phone technology.
  • Mobile applications that permit a patient or caregiver to create and send an alarm or general emergency alert 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 the information gathered during a prior visit to a doctor or historical trending and comparison of vital sign (e.g., body temperature and heart rate, blood pressure, or respiratory rate);
  • Software functions that reveal patterns in personal health incidents (e.g. hospitalization rates or alert notification rate)
  • Software functions allow users to gather (electronically or manually input) blood pressure information and share this data through email, track and analyze it, or add it to an electronic or personal health record;
  • Mobile apps that allow to monitor and remind you about oral health or tools to monitor users suffering from gum disease.
  • Mobile apps give patients suffering from prediabetes advice or tools to help them establish better eating habits or increase their physical exercise;
  • Apps that let users display messages and images on their smartphones, which are a great option for users of drugs who wish to end their addiction.
  • Software functions that report drug interaction and safety information (side effects and drug interactions, active ingredient, active ingredient) in an analysis based on information about demographics (age and gender), current diagnosis (current medication) as well as clinical information (current treatments).
  • Software functions that permit surgeons to determine the best intraocular lens powers for the patient and the ideal axis for implant based on the information given by him (e.g., expected astigmatism caused by surgery, patient’s axial length, preoperative corneal astigmatism etc.).
  • Applications, mostly mobile that converts a mobile platform to an approved medical device.
  • Software that connects to a mobile device by using a sensor or lead to measure and display the electrical signals produced by the heart (electrocardiograph, ECG).
  • Software that connects an eye sensor to the mobile platform or other tools in the platform, to view the eye movements, record and analyze the eye movements to diagnose balance disorders
  • Software that asks potential donors about their donor history and their records and then sends those answers to the blood collection facility. The software will determine the eligibility of a potential donor to donate blood or any other component.
  • Software that is connected to an existing device type to control the device’s operation, function or energy source.
  • Software that changes the settings or functions of an infusion pump.
  • Software that controls the deflation or inflation of a blood pressure Cuff
  • Software that calibrates hearing aids and assesses sound intensity characteristics and 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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