athenahealth, Inc. (Watertown, MA)

To manage a medical office, a medical practice management system can be used. The medical practice management server communicates with a client for medical practices user interface over a first network. It also communicates with a payer server on an additional network. The medical practice management server receives details about the patient’s visit to the doctor’s office. Prior to submitting a claim the medical management server communicates automatically with the information. The management of the medical practice server takes an corrective action in response to a finding of an error in the data and then uses the data to create an insurance claim.

For decades, high administrative expenses associated with filing and processing insurance claims have created a major problem for insurance companies. There are a variety of data that are associated with the insurance claim, for instance, the patient?s eligibility for particular medical procedures. The sad reality of today’s healthcare industry is that billions of dollars are wasted every year due to improper handling of claims for insurance. Furthermore, the process of these claims can waste precious time, resulting in an average revenue recognition time of more than seventy days.

For instance an example, medical professionals (e.g., a receptionist) is able to verify the insurance eligibility of a patient by calling the insurance company. The receptionist is also able to request information regarding the eligibility of the patient through an electronic portal linked to the website of the company. The portal lets the receptionist to input information regarding the patient and sends the information to the insurance company’s server. Once the response is received and the receptionist has to manually input details into the computer at the medical practice. Data entry errors are common due to the many steps involved in this task and the immense workload that is placed on professionals who perform these tasks. These errors can slow down the process of successfully sending a valid claim to an insurance provider. Medical professionals, e.g. the receptionist is prone to forgetting to perform an eligibility test. This could result in significant claims processing and billing issues.

Other areas associated with the administration of a medical practice for instance, the claim acknowledgement area, often experience similar or similar issues. Particularly, once a medical practice files an insurance claim to the insurance company, the medical professional generally must sort through a variety of claim acknowledgement reports to find out if the claim made it to the right place. This is a time-intensive manual process that is likely to be inundated with human error. As an example, there could be errors when comparing the contents of a report with claims submission records stored in an application for managing medical practices. The process of verifying the status of the claim as it progresses through the insurance company’s system is another aspect which is frequently affected by similar issues.

There is a need for a better way to manage a medical practice and make insurance claims.

The invention works in a way that is automatic and continuously with the insurance company’s system. It also uses rules to effectively manage a practice and decrease mistakes in insurance claims. The invention provides the method of managing a medical office. This procedure involves communicating with a user interface for a medical facility over one communication network, and an payorserver via a different communications networks. It also involves receiving information associated with an event that is related to patients from the user interface for the medical practice’s client interface and/or the payor server and performing one or more tasks that are associated to the particular event. The information associated with the event is used to generate an insurance claim following the completion of the task(s). The invention also automatically and repeatedly interacts with the information that is associated with the event, in relation to the tasks performed using one or more rules in a set of rules, and/or performing transactions through the payor server.

In one particular embodiment, the method includes the step of verifying the information prior to, during, and/or following doing the task(s) related to the event. The method may also involve receiving an error message and performing acorrecting action that could include sending an error message indicating an error to the medical practice.

In a different way the invention also includes the management of medical practices. Medical practice management includes an interface for a user of the medical practice interface, a payor server, and the medical practice management server computer. The medical practice user interface communicates with patients and the payor server connects to an organization that pays. The medical practice management system receives information from the client interface or payor server regarding an event connected to a particular patient. The workflow processing engine, a rules engine, as well as an intelligent transactions relation module are all parts of the medical practice management server.

The workflow processing engine is responsible for one or more of the tasks that are associated with the event , and the rules engine repeatedly and automatically communicates with the information that is related to the event by applying one or more rules from the form of rules that are applied to the information that are related to one or more of the tasks. Intelligent transaction relationship module conducts transactions through the payor server to facilitate the execution of some or all of the tasks.

In one particular embodiment, the engine for workflow processing additionally has a verifier for confirming the information before, during, or after performing the tasks related to the event.

Click here to view the patent on USPTO website.

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What is a software medical device?

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

Section 201(h) of the?Federal Food Cosmetic, Drug, and Act, ?21 U.S.C. 321(h),(1) defines the term “medical device” as apparatus, instrument or machine implants, devices, contrivances in vitro regulator, and other related items in addition to an accessory or component. . . (b) is intended to be used to diagnose disease or other conditions, or for the cure, mitigation, treatment, or prevention of disease, in man or other animals, or (c) is designed to affect the structure or functions of the body of man or any other animal.? Therefore, in order to be considered a medical device, and thus subject to FDA regulations, your software must meet one of two criteria:

  • It is essential to use it in the diagnosis and treatment of patients.
  • It should not be designed to alter the structure or function of the body.

Thus, if your software is designed specifically for health professionals to treat and diagnose patients or used in hospitals to manage patient information The FDA will likely consider such programs as medical devices subject to review by regulators.

Is Your Software a Medical Device?

FDA is only applying its oversight of medical devices that have functions that may pose a risk to the safety of patients according with the current FDA surveillance approach. FDA currently considers the capabilities of the platform more than the platform. Examples of Device Software and Mobile Medical Apps that FDA is focused on include

  • Software functions to aid patients with diagnosed mental disorders (e.g., depression, anxiety, post-traumatic stress disorder (PTSD) and others.) by offering “Skill of the Day” an approach to behavior or audio message that users can access when they are feeling anxious.
  • Software functions provide periodic reminders, motivational guidance as well as educational information for those recovering from addiction or smokers trying to quit;
  • Software functions that make use of GPS location data to warn asthmatics when they’re near high-risk locations (substance abusers), or to alert them of potential environmental conditions that could cause symptoms.
  • Software functions that use video and video games to motivate patients to perform their physical therapy exercises at home;
  • Software functions which prompt users to choose which medicine or substance they want to take simultaneously. They also give information on interactions and provide the details of the kind of interaction.
  • Software functions that take into account patient characteristics, such as gender, age, and risk factors, to provide individual counseling, screening and prevention advice from well-established and respected authorities.
  • Software functions that utilize a list of typical symptoms and signs to give the possibility of health conditions and advise on when to consult a health care provider;
  • Software functions allow users to complete a questionnaire regarding their symptoms and then make a recommendation on the most suitable health care facility for the patient.
  • The mobile apps enable users to make pre-specified nurse calls or emergency calls using the internet or cell phone technology.
  • Apps that permit patients or their caregivers to communicate emergency alerts to first responders using mobile phones
  • Software functions keep track of medication and offer user-configured reminders to ensure better compliance with medication;
  • Software functions that provide patients a portal into their personal health information including access to the information gathered at a previous visit to the doctor or the historical trending and comparison of vital signs (e.g., body temperature and blood pressure, heart rate, or respiration rate);
  • Software functions that aggregate and display trends in personal health events (e.g. hospitalization rates or alert notification rates);
  • Software tools let users either manually or electronically enter blood pressure information, to share it via e-mail as well as track and track it, then upload it to your personal or electronic health record.
  • Mobile apps that offer oral health reminders or tracking tools for those suffering from gum disease;
  • Apps that offer mobile guidance and other tools for patients with prediabetes;
  • Applications that permit users to display images and other messages on smartphones, which can be used by users of drugs who wish to quit addictive behaviors.
  • Software functions that report drug-drug interactions and relevant safety information (side effects, drug interactions active ingredient) as a report , based on demographics (age, gender) as well as clinical information (current diagnosis) and the current medication and
  • Software functions provide the surgeon with an inventory of intraocular lens powers and recommended an axis for implantation based upon information supplied by the surgeon (e.g., expected surgically-induced astigmatism that is likely to occur, patient’s axial length and corneal astigmatism preoperatively and so on.)
  • Software, typically mobile apps, that converts a mobile platform to an approved medical device.
  • Software that communicates with an mobile platform using an instrument or lead to display and measure electrical signals generated by the heart (electrocardiograph; ECG).
  • Software that attaches an eye sensor to the mobile platform, or other tools within the platform, in order to monitor or record the eye movements in order to detect balance disorders
  • Software that questions potential donors about their donor history and their records and then sends those answers to an institution for blood collection. This software determines whether a person is eligible to collect blood or any other component.
  • Software that can be connected to an existing device type to control its operation function or energy source.
  • Software that alters the settings or function of an infusion pump.
  • Software that regulates the deflation or inflation of the blood pressure Cuff
  • Software that calibrates hearing aids and evaluates the sound intensity characteristics and electroacoustic frequency 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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