Compliance and Regulations in Healthcare 2025

Compliance and Regulations in Healthcare 2025
March 01 2025

We’re all aware of how COVID-19 has impacted the way we live, ranging from changes in travel, business, and education to social interactions. Of course, the health sector was the most affected, acting as a frontline for the unfolding story.

The outbreak revealed that the technological aspect of healthcare could be an exciting method of digitalization. This can help address the huge demand in clinics and broaden the scope of healthcare and the ways of delivery to patients. This is where healthcare software come into the market.

“According to Statista, in 2024, the market for digital health reached$172 billion and is expected to grow at a rapid rate. In the year 2024, more than 1.3 billion people were using these apps.”

The market will exceed $300 billion in revenues by 2025, highlighting the importance of these apps in patient care, health monitoring, and health management. As technology advances, the demand for health mobile apps will grow.

What is Healthcare Software Development?

Healthcare software development is all about creating apps for healthcare and medical sectors to improve patient care, simplify processes, and guarantee timely medical interventions.

The purpose behind such improvement extends to enhancing patient engagement, decreasing delays in healthcare delivery, ensuring accuracy in diagnosis and treatments, and improving operational efficiency.

It also opens the way to remote monitors and even telemedicine, which allows healthcare professionals to reach more patients while providing convenient and personalized healthcare solutions.

Difference Between Healthcare and Medical Applications?

Knowing the difference between medical and healthcare applications is essential for CTOs who are attempting to enter the field of digital health development. Although they are often referred to interchangeably, they serve distinct objectives and target people in the health sector.

As part of this comprehensive app guide to development, we have identified the major differences between these two apps below:

  • Healthcare Applications: Healthcare Applications are more extensive, covering an array of interactions and services between healthcare professionals, patients, and administrative personnel. They seek to streamline the entire process of managing healthcare, increase patient engagement, and enhance overall healthcare delivery.
  • Medical Applications: On the other hand, medical software is specifically created to assist medical specialists in diagnosing and treating patients. It is more clinical and focused on providing accurate medical data, diagnostic tools, and treatment plans.

Benefits of Healthcare Mobile Applications

The increasing demand for apps that aid in healthcare can be attributed to the ease of use and accessibility they provide patients as well as medical professionals. Here are the main benefits of creating a health application :

More Patient Engagement and Satisfaction

With healthcare software development, patients are more involved with their health condition. This is due to the integration of advanced features, such as reminders about their medications and real-time communication with doctors.

They can deal with their illnesses more effectively. About 80% of patients are more involved with their healthcare providers, improving their satisfaction.

Additionally, a number of medical facilities are making progress in advancing healthcare for patients by using AI to create apps for healthcare. This way, patients will be able to answer their questions at a moment’s notice and be more pleased with the results of their treatments.

Reduces Cost and Streamline Medical Processes

Apps for healthcare give patients the chance to avail themselves of medical treatment. Through the use of mobile health apps, users can maintain their health without being admitted into hospitals. This streamlines the entire process of medical treatment. All they require is Internet access and access to mHealth applications.

Another benefit of creating healthcare software is their cost-effectiveness. This is due to improved resource allocation and patient management. Additionally, by offering healthcare services available via healthcare software, costs can be reduced through the absence of travel for appointments, hospital forms, etc.

Better Data Collection and Insights

Mobile apps for healthcare are extensively used to gather huge quantities of information about patient behavior, health indicators, and results. Healthcare facilities can use most of these data to study trends and analyze them, which can help predict patient needs and create the necessary treatment plans.

Doctors can make use of the data collected to provide individualized medical care. A healthcare software development company can increase the capabilities of your app in response to user behavior and feedback.

Provides Comfort & Convenience

The apps for healthcare allow patients to access services from their homes. In remote areas, patients must travel away to visit specialists and receive appropriate treatment. This can be a challenging job when the patient is elderly or a child.

Healthcare software link patients directly with their medical professionals, eliminating problems like traveling long distances to see a doctor. Healthcare software makes it easier for those who live in remote areas and don’t have many choices. They can communicate with doctors online. So, if you’re a physician, you could offer your patients more assistance. You can also share their medical information and prescriptions at their access.

Elimination of Administrative Work

One of the major advantages of using healthcare software is that they enable doctors and patients to keep track of every detail in their reach. This reduces their workload and allows them to offer treatments to various patients at once.

mHealth applications handle tasks like appointment scheduling and information management. They also help eliminate the need for paperwork for physicians and those seeking medical services.

Enhanced Communication Between Patients and Providers

With the advancement of new technologies, patients do not have to wait around for long to talk with their doctor. There are a variety of video and messaging options available.

The inclusion of modern capabilities into healthcare software lets patients communicate with healthcare professionals in real time. Another benefit of constant communication is that it aids in creating a stronger doctor-patient relationship. This way, patients receive the treatment they require. However, when you develop a mHealth application for your clients, you must comply with HIPAA to create an app that conforms to the industry’s standards.

Regulation and Compliance for Healthcare Software Development in 2025

To comprehend the significance of ensuring compliance with healthcare regulations, it is important to comprehend the purpose of federal, state, local, and industry regulations and the reasons they are in place. While it’s not feasible to give a brief overview of the purpose behind every regulation in the field of healthcare, the following list offers an overview of the regulations that a healthcare facility may have to adhere to.

Conditions of Participation in Medicare and Medicaid

The first conditions for participation in the federal Medicare and Medicaid programs were released in 1966 by the Social Security Administration to provide an initial level of treatment for eligible beneficiaries across the United States. Since the Medicare and Medicare programs expanded, more conditions for participation were included, and the responsibility for enforcing compliance was transferred to HHS’ Centers for Medicare and Medicaid Services (CMS).

Emergency Medical Treatment and Active Labor Act (EMTALA)

Another way healthcare organizations could be exempted from federal health programs is by breaking EMTALA. Congress adopted EMTALA on September 15, 1986, to stop practices like “patient dumping,” a method by which healthcare providers did not provide medical emergency treatment to people because patients could not afford it. The Act also bans healthcare institutions from releasing patients early because the cost of treatment is expected to be high.

Payment Card Industry Data Security Standards (PCI DSS)

PCI DSS refers to a legal obligation (rather than an official rule or regulation) that aims to ensure the security of credit and debit card transactions and protect cardholders from theft, fraud, and use of personal data. The standards in actual practice closely correspond to the Technical Safeguards of the HIPAA Security Rule. Therefore, healthcare institutions that comply with those standards will automatically comply with the HIPAA Security Rule and will automatically conform to PCI DSS.

Physician Payments Sunshine Act /CMS Open Payments

The Physician Payments Sunshine Act is an Act that requires the disclosure of financial transactions between healthcare providers and drug companies, including manufacturers of medical supplies, biologics, and medical equipment. The goal of this Act is to eliminate conflicts of interest that may cause (for instance) patients to receive a non-suitable medication or an unneeded treatment because medical professionals have a financial stake in providing the treatment.

The Health Insurance Portability and Accountability Act (HIPAA)

The intent behind HIPAA was to improve the healthcare insurance industry. However, because of fears that the costs of these reforms would be passed on to employers as well as employees as more tax-deductible, higher premiums—and the negative impact this would have on Treasury revenue—Congress took measures to reduce the burden on those in the insurance business by eliminating waste, fraud, and misuse in the healthcare sector and by facilitating the administration of healthcare transactions.

HHS’ Office of Inspector General Exclusions List

HHS’ Office of Inspector General (OIG) is a probe into people and organizations that may be accused of committing fraud, abuse of patients, and neglect, as well as other instances of misconduct, for instance, violations or violations of the Social Security Administration’s Anti-Kickback Statute or the Stark Law. Organizations and individuals found guilty of fraud, misdeeds, or fraud are deemed ineligible for any of the Medicare and Medicaid programs, in addition to being punished with a fine or the possibility of a prison sentence.

Occupational Safety and Health Act

The Act on Occupational Health and Safety (OSH Act) was passed in 1970 and established the Occupational Safety and Health Administration (OSHA). The administration was given the authority to create standards for health and safety at work to reduce accidental injuries, accidents, and workplace diseases due to unsafe working conditions. The administration implements the standards through an inspection program and investigation in response to injury reports and employee complaints.

Food and Drug Administration (FDA) Regulations

In addition to other duties, the FDA assures the safety and efficacy of biologics, medicines, and medical devices. However, since the FDA is the administration that enforces more than 200 laws, regulations, standards, and standards, there is no universal method for FDA compliance with regulations in healthcare. Every healthcare facility is responsible for determining the FDA laws, regulations, and standards about their operations and then implementing compliance programs specific to each.

State Privacy and Data Security Legislation

Data security and privacy laws of state legislation could cause more compliance issues for healthcare institutions than federal laws. Currently, 19 states have passed a form of privacy, consumer protection, or data security laws, and 17 states have passed legislation at the committee stage or higher. In many instances, legislation passed by state legislatures can boost a healthcare organization’s compliance with its regulatory obligations by filling in holes in federal legislation.

Types of Healthcare Mobile Apps

Healthcare software vary widely, including telehealth platforms, chronic illness management tools, and fitness applications. Healthcare software for running is a good example, as it focuses on creating apps that measure runners’ performance and provide them with information about their fitness levels. Based on the kind of services you offer, you must select the app type that meets your requirements most effectively. We’ve compiled the most popular medical apps that are available.

General Hospital Apps

General hospitals’ healthcare apps can enhance their communication with patients and be used as a tool for promotion.

The most important features of the general hospital apps are:

  • electronic health records (EHR) integration
  • Doctors’ profiles and availability
  • Patients’ profiles on which they can get their lab results or prescriptions electronically
  • A list of the treatments and services the hospital offers
  • Time to wait in an emergency room

In addition, some hospital applications may focus on appointment management. These apps typically include calendars that allow both patients and medical professionals to keep track of future appointments and medical procedures. Virtual appointments through video or audio calls are also important during the post-pandemic period.

Be aware that developing hospital apps typically requires collaboration with medical facilities to create useful applications that can be used in real-world settings.

Telemedicine Apps

Often referred to as doctor-on-demand apps, these platforms were designed to offer medical services via the Internet. Both the patient and doctor usually communicate through audio, text, and video channels.

The primary advantages of telemedicine apps include:

  • Electronic Health Record (EHR) integration
  • patient profile and dashboard
  • Doctors’ profile, including reviews and ratings
  • appointment management
  • text audio, video, or text chats
  • e-prescriptions
  • payment gateway

Telemedicine applications can also be built on Internet-of-Things technology. This means that patients can use other equipment to measure their blood pressure and sugar levels, as well as other vital signs, which are then delivered to a doctor to provide more efficient treatment.

Mental Health Apps

The goal of these apps is to aid in controlling any type of mental issue. It doesn’t matter if it’s depression, anxiety, or eating disorders. These apps can give patients the tools to track and boost their improvement.

Usually, mental health apps may include:

  • Text or audio chat feature to communicate with therapists
  • Therapy session scheduling
  • Progress trackers
  • ways to boost mental health, including meditation tools
  • Chats with support groups
  • Medical health records of patients

Urgent Care Apps

Also known as ER platforms, they are designed to help those in emergency situations receive the assistance they require. They typically provide directions to the emergency department for people with or without insurance and show wait and travel times.

Some of the most well-known characteristics of apps for urgent care include:

  • GPS tracker
  • cost estimate calculator
  • Contact the emergency department’s contact database
  • Emergency contacts, such as contact numbers for close family members

Furthermore, these apps could give basic directions that could aid those in an emergency situation and provide primary medical aid for the person. For instance, they could help bystanders help the person who is having a seizure.

Diagnostic and Preventive Care Apps

The main focus of these applications is diagnostic medicine, which means they give patients access to their medical history and test results and allow them to schedule tests. Additionally, they can provide symptom checkers that aid patients in identifying which tests they should undergo and which doctors they should visit.

The most common features of diagnostic apps include:

  • electronic health records (EHR) integration
  • Medical test scheduling, costs, and lab results
  • A symptom checker and AI-powered diagnosis assistant
  • appointment management
  • Guides and helpful information about managing chronic illness and living a healthier lifestyle

Apps for a healthy lifestyle

The number of subcategories for this type of application is endless. Mobile platforms like these allow you to track your daily calories, fluids, steps, and sleep quality. A few also remind users to get regular check-ups with their doctor. The idea is to inspire users to adopt a healthy lifestyle and prevent diseases of the body.

Although the primary features are contingent on the goals of the app, the most commonly used features are:

  • Users’ profiles include their activity level, weight, medical issues, etc.
  • habit tracking
  • Push notifications
  • guidelines on the proper diet or the best sports activities

Factors That Makes a Healthcare Software Successful

Before starting, you must make sure that you have a competent developer team that can transform your idea into a profitable application. It is important to research the factors that make an app for digital health successful.

User-Friendly Navigation

Another important aspect of a successful user experience is an easy navigation process. Users want to move quickly and effortlessly from one section or page to the next.

If users cannot figure out how to navigate to your application or hit a wall and stop using it, they will abandon it completely. Make it simple for users to understand how to use your app and move from one area to another.

Solutions to Patient Problems

Your app for healthcare should address the issues that its customers face. If you design a healthcare software that does not alleviate problems or ease users’ lives, there’s not much reason to use it. Your aim should be to enhance the lives of those who require it the most by offering services they will truly appreciate, such as immediate scheduling, a symptom checker, or even an online database.

Integration of Latest Technologies

Experience is the most crucial element to consider when developing healthcare software. The team that develops your app should have plenty of knowledge to create an expertly designed, polished application.

The team should comprise developers, graphic designers, and people with a solid understanding of health care to provide accurate and useful details for your application.

Great User Experience

An excellent customer experience can be more crucial than any other aspect. If your app isn’t straightforward to use or easy to comprehend, the user will simply uninstall it and continue to their next adventure. You must ensure that all your features are accessible to users of all ages so they can comprehend and use them regardless of age or degree.

Conformity to Government Regulations

If you work in the healthcare field, it is essential to ensure that your app complies with government regulations. While this can be different for various states or countries, compliance must be a top priority during the mHelath app development process.

In the United States, your application must comply with the Health Insurance Portability and Accountability Act of 1996 (HIPAA), while the EU demands that you comply with the General Data Protection Regulation (GDPR).

More Value Than Other Apps Could Offer

One of the most effective methods to ensure the success of your app for healthcare is to offer greater value than any other app can. Your app should offer something unique to the market.

For instance, a million symptom checker apps are available. Your app will stand out with more content, a more pleasant user experience, or the ability to communicate with a healthcare expert.

Emerging Trends in Healthcare Software Development

Technology is constantly evolving. This is why mobile healthcare software growth continues to increase. These are the major trends driving this market.

Data Security and Interoperability

Blockchain technology improves the security of healthcare software that have been developed. This advanced technology helps create smart contracts that protect transactions. Additionally, FHIR improves data exchange within the healthcare industry. These systems ensure the accuracy of health information. It is also important to note that blockchain can comply with regulations. EHR platforms could benefit from these advancements to make data sharing safer and more effective.

Wearable Technology and IoMT

Imagine having a health assistant who never stops working. Wearable devices and IoMT are the tools patients require! Healthcare software utilize the two technologies to keep track of health data throughout the day. The apps provide proactive health management. Patients with chronic ailments can deal with their issues because of the real-time tracking feature.

Artificial Intelligence and Machine Learning

AI Machine learning and AI are growing rapidly. Health apps are now equipped with predictive analytics, personalized medicine, and decision assistance. These capabilities are all outcomes of AI. AI also assists in patient healthcare and ensures the accuracy of diagnosis.

Telehealth Integration

Are you looking to get healthcare at home? Telemedicine and integration with telehealth can help. These technology options allow remote monitoring of patients (RPM) and can improve patient outcomes through continuous care.

Future Trends

Technology isn’t finished! New technologies such as 5G and AR/VR will alter healthcare software development in the future. 5G will allow the faster transfer of data, and AR/VR can enhance the training process and improve patient experience. Healthcare providers can consider improving the performance of their apps. If you are following trending trends, make sure to follow health regulations.

Steps to Develop a Healthcare Software

You’ve read about the difficulties that can arise while creating a health app and ways to deal with these issues. It’s time to continue developing the app to help you manage your health. We’ll review the step-by-step healthcare software development process.

Identify the Problem

The initial stage of the process of an app for healthcare is to study the issue. Write down the issues you wish to address by using an online healthcare solution. It is also important to look up other applications available on different online platforms and their USPs (Unique Selling Proposition) and issues. This will help you create the right design for your healthcare software.

It is also important to consider the potential audience you are targeting. Determine the age range and gender, geographic location, niche, and other categories that determine your market.

Define Features and Functionalities

After you’ve identified your group, you can begin explaining the functions and features of your healthcare software. The app should have features and functions that draw users’ attention and provide them with comprehensive support.

Design UI/UX

Next in the creation process of a healthcare software is to create its user interface/UX. This UI is the first element of the app that users interact with. Utilizing a healthcare software may be difficult for users to use, so you need to develop the user interface and UI of the application in a straightforward, elegant, appealing, and practical method to attract the attention of a larger number of users.

You must use appealing backgrounds, fonts, colors, and optimal font sizes, as well as other components in the user interface. The mHealth app must be designed to be easy to use for users.

Develop a Prototype/MVP

The creation of an MVP (Minimum Viable Product) of a health app is an essential phase in the development process. The MVP acts as the basis for the end product and assists in verifying the idea and the features. In order to create an MVP, it is first necessary to determine the essential elements you would like to add to your application. Then, you can create an app prototype to determine the viability of your idea.

An MVP is a way to collect feedback from users who may be interested in enhancing the app’s features and functionality. After you’ve completed your MVP, you can proceed with developing the app’s healthcare features and start developing your final version.

Test Your App

Once you have created the final version of your healthcare software, you should move on to the next step, which is testing. Testing is a very rigorous procedure throughout the development process of a healthcare software since it requires numerous iterations.

You must consider a variety of methods of testing, including the integration test, unit tests for functionality, regression, and much more. These testing methods will allow you to analyze the different aspects of your healthcare software. It is also possible to conduct beta testing to test your app’s performance against the real-time users of your app to get a view of your target market.

Deploy It On Various Platforms

Once your app has been verified using various methods and isn’t prone to bugs, ask the healthcare software development company to deploy it on various platforms, including the Google Play Store, Apple App Store, and more. Be sure that your app meets all the requirements, rules, and guidelines of these platforms so that there aren’t any problems when you upload your application.

Support & Maintenance

The process of developing a health app doesn’t stop only with its release in apps; you need to provide support and ongoing maintenance for the app for users. Maintenance and support involve fixing any technical issues, bugs, or other errors that could occur within the application.

It also involves updating the app to include new functions and features and ensuring that it is compliant with the most current regulatory requirements and industry standards.

By following these steps, you can create a contemporary and interactive healthcare software that will help you make your mark in the market and draw a wider potential audience.

Tips to Monetize Healthcare Software

How you earn money from the customized healthcare solution you create depends on the product. Will it be an app for hospital patients, a medical mobile application for health professionals, or an IoT companion app connected to a smart device? Here are a few ways to make money from these variations.

Service Sales

One-time purchases of a variety of products and services your company provides.

Sponsorship

This is especially helpful when your app requires using certain models of medical equipment or other items.

Pay Per Download

The oldest version in the mobile market is also the least used today because you’d need to maintain the free version, which has only a few functions, or your customers wouldn’t be able to test the software.

Patient Data

Pharma companies and other companies involved in medical research will be willing to pay for anonymized patient information and other medical information that your solution collects.

Subscription

Receiving scheduled payments from your subscribers makes your accounting more satisfied. This is useful not only for mobile apps designed for regular use but also for web solutions. In the world of b2b, we call it SaaS commercialization, and it functions exactly the same.

Ads

Never consider using ads to solicit an offer to turn off. It will either annoy customers or cause you to waste too much time evaluating the relevance and quality of advertisements.

Licensing

This monetization model is similar to the B2B SaaS model; however, when you offer the license that you use to run the software, you earn royalty.

Device sales

The hardware price usually includes software if you are selling smart medical sensors that communicate using an IoT mobile application.

The Key Takeaway

It’s not hard to imagine how the sheer number of regulations, both mandatory and voluntary, that healthcare organizations might have to adhere to and the number of changes that could take place as a result could increase the risk of failing to comply. It’s also easy to imagine how a well-funded compliance department with a well-developed risk management approach could miss a critical specification for implementation because of the sheer number of similar demands.

If configured to meet the needs of an organization, such as healthcare regulatory compliance software, it can also create risk assessments that are guided for each business unit. When the risk assessments have been completed, the software will create a corrective plan of action if compliance gaps are found. 

The software may be used to determine the need to modify procedures, policies, and business practices that might be required due to modifications to or new regulations standards. Businesses that are interested in making use of software for healthcare regulatory compliance should seek out expert assistance with compliance.