E-Prescribing App Development: Tech and Legal Issues
When developing a new app, it's crucial to make sure you're aware of the tech and legal issues that could impact your project.
This is especially true when you're creating medical software, which could face a number of challenges in terms of security and compliance. If you're not prepared for these potential roadblocks, your app development process could be derailed.
That's why it's important to explore the legal framework and consult with an attorney and a technology expert early in the process. Thorough preparation can help you identify potential problems and find solutions to stay on track and bring your app to market.
This article will discuss some of the key tech and legal issues to consider when developing an e-prescribing(eRx) app.
E-prescribing in the US: on-premises and SaaS
E-prescribing is rapidly growing in the US and worldwide. A recent study found that the e-prescribing market is expected to grow from $1,2 billion in 2020 to $3,3 billion by 2025.
Another study shows that the cloud model and e-prescribing SaaS are dominant over on-premises applications. This is not surprising, because SaaS allows users to reach the application anytime, from anywhere, by logging into the program through a browser. On the other hand, on-premises programs must be installed on a specific device and can only be accessed from it. Thus, doctors can only make electronic prescriptions in the office during business hours.
The debate between SaaS and on-premises software development is one that is constantly being discussed in the tech world. Here's our take on it:
SaaS is a great choice for companies that are looking for a fast and affordable way to get their product up and running. It's perfect for startups that are working with a limited budget, and it can be scaled up or down as needed.
On-premises, on the other hand, is a good option for companies that want more control over their product. It provides a high level of security and can be customized to meet specific needs. However, it can also be more expensive and time-consuming to set up.
eRx software tech stack
The choice of a technology stack for your electronic prescriptions software will greatly depend on whether you develop on-premises or SaaS.
In the first case, you will need to independently deploy the IT infrastructure, purchase IT equipment, and maintain servers. You also will need to collaborate with software and hardware specialists who will maintain your IT infrastructure and keep your app running.
If you decide to develop SaaS, you will need to carefully choose a cloud service provider. Based on our ten years of development experience at Erbis, we recommend choosing between AWS, Microsoft Azure, and Google Cloud. Each of these providers offers a wide range of development, deployment, and app maintenance tools. You need to compare the features and prices of the tools in which you are interested, and partner with the provider of your choice. If you decide to work with Amazon, consider checking out our post on how to save money on AWS services.
Whichever software development model you choose - on-prem or SaaS - you will need to:
choose frontend and backend development languages for your e-prescribing app
set up data storage and data processing tools
buy or rent servers and set up a load balancer
configure monitoring and performance tools
create custom APIs
integrate BI and analytics tools
Below you can see the example of the tech stack we used during the development of the EHR system for a France-based pharmaceutical company.
Such a tech stack was chosen after conducting a thorough business analysis, creating a detailed product vision, and considering the client's budget and deadlines. At Erbis, we always adhere to the approach of careful planning and preparation before starting project development. So, if you need expert technical advice, don't hesitate to get in touch.
State laws, EPCS, and HIPAA compliance
As you are planning your go-to-market strategy for your e-prescribing app, it's important to be aware of legal regulations at the federal and state levels. The key regulation acts to consider are EPCS and HIPAA.
EPCS is the use of Electronic Prescriptions for Controlled Substances, which is federally mandated under the Controlled Substances Act. The EPCS regulates the rules for issuing electronic prescriptions for physicians and provides requirements for the processing of these prescriptions by pharmacies. Here are the key points covered:
Secure data access through multi-factor authorization
Prescription validation through digital signature
Time requirements within the defined threshold of the NIST time source
Audit procedure for specific prescription medications
Audit logs for saving and archiving
Physical data security during processing and storing
HIPAA is the Health Insurance Portability and Accountability Act, which sets national standards for the privacy and security of protected health information. HIPAA compliance for e-prescribing software means:
having strict requirements for the non-disclosure of patient information
establishing strong data security at physical, technical, and administrative levels
imposing fines and other liability for violation of data security rules
In addition to the above mentioned acts, there are many other regulations at the legislative level for e-prescribing and other medical solutions. If you're not sure which laws to follow when developing your e-prescribing app, use the Mobile Health Apps Interactive Tool developed by the Federal Trade Commission. All you have to do is answer a few questions about your software and the tool will tell you which law you should apply.
Additionally, check local eRx software regulations, as they vary from state to state. Most of the US states now have e-prescribing mandates to help fight the opioid epidemic. The map below displays current and pending regulations. You can see that some states require electronic prescriptions for all drugs, while others make them mandatory for specific pharma groups, such as opioid-containing instances. A minority of states do not have e-prescribing mandates or are in the process of introducing them.
Top 5 features of e-prescribing apps
E-prescribing apps are becoming increasingly popular on iOS and Android platforms. There are a number of different features that these apps offer, which makes them very useful for both doctors and patients. Here are the top 5 features to consider when implementing electronic prescribing software.
Prescriptions sending and receiving. First of all, your e-prescribing tool should enable doctors to issue electronic prescriptions, patients to place orders according to prescriptions, and pharmacies to receive and process these orders. To implement this, you need to connect to the databases of authorized pharmacies and make sure that your app request goes through the secure protocol. Once the pharmacy receives the medicine prescription they should confirm or deny the request, and the patient should immediately see the order status update.
Checking for drug interactions. This feature helps doctors rest assured that their patients don't experience any dangerous interactions between medications. To use it, the doctor enters the name of the drug and the dosage, and the app checks for any potential interactions and tells the user about them. To make decisions about medicine compatibility, e-prescribing software should have a comprehensive drug database and an advanced AI algorithm that will extract information from drug instructions.
Tracking prescription history. This is a great feature for doctors because it allows them to see a patient's complete medication history, including prescriptions that have been filled and refilled in different pharmacies. It also makes it easier for doctors to prescribe medications because they can see what the patient is already taking. Before giving doctors access to their prescription history, the patient’s consent must be obtained. Therefore, an “Ask for Consent” feature should be implemented, informing the patient of exactly what personal data will be shared.
Setting up refill reminders. This allows patients to receive automatic notifications when it's time for them to refill their prescriptions. This is a great way to help them stay on top of their medication schedules and avoid any potential gaps in treatment. You can allow both doctors and patients to set up refill reminders. The reminders set by doctors will be sent as push notifications to the patient's mobile device. Don't forget to let patients turn the alerts off.
EHR integration. Today many medical institutions use all-in-one digital health solutions, which include EHR, medical practice tools, e-prescribing apps, mental health services, and more. When you develop an eRx program, you need to consider the possibility of integrating it with EMR and other medical software. To do this, you need to make a convenient custom API that will allow third-party services to safely integrate with your eRx tool.
Conclusion
When you're developing a new e-prescribing app, it's important to keep in mind the potential tech and legal issues that could arise. By planning ahead and having a clear understanding of both your product and the law, you can avoid any potential problems down the road.
If you're not sure where to start, it's a good idea to consult with a lawyer who specializes in technology law. You can also contact an experienced development team with many medical projects under their belt. If you are looking for such a team, contact us, we'll be happy to help!
