FDA-Compliant Software Development Solutions
Our commitment to FDA-compliant software development stands as a testament to our dedication to advancing healthcare technologies and solutions. We specialize in developing software solutions that go beyond the boundaries of innovation and fulfill the rigorous requirements set by the U.S. Food and Drug Administration (FDA).
Regulatory Consultation
HIPAA Privacy Rule is to safeguard patients’ sensitive health data by establishing guidelines that healthcare providers, health plans, and relevant entities must adhere to.
Validation and Verification
The HIPAA Security Rule serves as a safeguard against the growing threats to digital health data, including cyberattacks, unauthorized access, and data breaches.
Quality Management Systems Implementation
This has two objectives: To notify individuals of potential breaches and to ensure that covered entities quickly address and mitigate such breaches.
Audit Preparation and Support
HIPAA Omnibus Rule is to enhance the current privacy and security measures for patients’ health data, particularly with the growing use of electronic health records.
Benefits of FDA Compliance Software
FDA compliance software offers several benefits to organizations involved in the development and distribution of medical devices and healthcare software. Some of the key advantages include;
Patient Safety
Enhanced Data Security
Quality Assurance
Streamlined Audits
Risk Mitigation
Improved Traceability
Why Choose Us
Deep Domain Expertise
Benefit from our industry knowledge and expertise, gained through years of dedicated experience in healthcare IT.
Customized Solutions
Our solutions are crafted to address your specific challenges and objectives, ensuring optimal performance
Seamless Integration
Experience hassle-free integration with existing systems and the flexibility to scale as your needs evolve
Compliance Assurance
Our solutions adhere to the highest standards of compliance and security, safeguarding your sensitive data.
Design Thinking Led Approach
We approach every project with a design-thinking mindset, prioritizing user experience and engagement to drive successful outcomes.
Healthcare Learning Center
Stay ahead of the ever evolving curve with our healthcare learning center, providing actionable and valuable insights and resources to empower your team.
Quality Boost Through Automation
Embrace automation for efficient workflows and better care.Our solutions minimize errors and optimize resources, enhancing quality
Clear and Open Pricing Structures
Our pricing structures are straightforward and transparent, ensuring you know exactly what you're investing in without any surprises.
Compliance-Driven Services
Our developers are HIPAA certified and skilled in various healthcare regulations, including GDPR and HITECH. We create HIPAA-ready solutions, ensuring security and compliance with all necessary standards. Trust us to deliver robust, compliant healthcare software that protects patient data.
Integration Expertise
EHRs
APIs Platform
Wearables
Cloud
EHRs
APIs Platform
Wearables
Cloud
Solution Accelerators
EHRConnect
EHRConnect provides a robust API/SDK for effortless integration with major EHR systems such as EPIC and Cerner, ensuring secure data exchange with advanced authentication and authorization protocols. Its support for diverse FHIR endpoints enhances data interoperability, facilitating efficient communication.
Read morePHISecure
PHISecure is a comprehensive solution dedicated to safeguarding Protected Health Information (PHI) within healthcare systems, ensuring compliance with privacy regulations like HIPAA. Its advanced encryption and access control features offer robust security measures to prevent unauthorized access to sensitive patient data.
Read moreWearConnect
WearConnect is a wearable technology platform facilitating seamless integration between wearable devices and various applications, enhancing user experience and data accessibility. It enables efficient communication and data exchange, empowering users to leverage the full potential of their wearable devices.
Read moreSecureSphere
SecureSphere provides a holistic infrastructure management solution, facilitating swift deployment within hours. It prioritises compliance, scalability, and high performance. Additionally, it seamlessly integrates advanced monitoring tools, underscoring a commitment to security and reliability throughout the infrastructure.
Read moreHealthcare Software Development
Telemedicine App Development Services
Our telemedicine app development facilitates contactless treatment and allows patients to connect with doctors via video calling or text. To protect your patient’s data, we develop HIPAA compliant apps.
Learn MoreCompliance in Healthcare
Do not let compliance processes slow you down. Protecting your healthcare data is our priority. Our team of compliance experts makes sure that your product or system meets the requirements of all the HIPAA, FDA, and Vanta regulations.
Learn MoreChildcare Management Solutions
We are crafting solutions around your healthcare needs and requirements. We offer not just childcare management solutions but an overall seamless experience for both childcare providers and parents.
Learn MoreDigital Dental IT Solutions
We are providing custom Dental IT Solutions focused on the dental industry. Our highly experienced team in the field of dental healthcare is here to simplify your technology journey ensuring seamless operations and enhanced patient care.
Learn MoremHealth App Development Services
We offer mHealth app development services for various platforms. From health information exchange to telemedicine and fitness tracking, we cover a wide range of healthcare-related apps.
Learn MoreMental Health Services
With mental health taking center stage, we're at the forefront of the movement to improve mental healthcare for everyone. Our solutions expertise in the field of mental health services is here to help you in every part of the industry.
Learn MoreFrequently Asked Questions
- What is required for the software to be HIPAA compliant?
Building HIPAA-compliant software should include measures such as access authorization with the appropriate user roles and permissions, regular backups, encryption, and constraints on physical access.
- Does HIPAA apply to health apps?
According to the Health Insurance Portability and Accountability Act (HIPAA), the Personal Health Record (PHR) includes almost all health applications that collect user data including apps that track mental health, medications, and fitness.
- To what extent are the HIPAA privacy policies used by HIPAA-compliant organizations customized for the application?
It depends. Most policy documents are standardized, so there’s not going to be a ton that needs to be customized. But you must figure out which policies apply specifically to your business model in light of your internal circumstances.
- How early should we designate a privacy compliance officer and HIPAA security officer?
As long as a compliance officer is described in one’s job description for an organization, then anyone in the company can work on ensuring a company meets its requirements for being HIPAA (Health Insurance Portability and Accountability Act) compliant. Read the detailed answer here.
- Do you sign a NDA?
Yes, we do. Our developers too are covered under NDAs and confidentiality clauses.
Let's Get In Touch
One thing that really stood out to me is the culture and values of the Mindbowser team.
Sanji Silva
Chief Product Officer, Mocingbird
I am so glad I worked with Mindbowser to develop such an Impactful Mobile app.
Katie Taylor
Founder and CEO, Child Life On Call
Mindbowser was an excellent partner in developing my fitness app.
Jirina Harastova
Founder, Phalanx
Mindbowser built both iOS and Android apps for Mindworks, that have stood the test of time. 5 years later they still function quite beautifully. Their team always met their objectives and I'm very happy with the end result. Thank you!
Bart Mendel
Founder, Mindworks
Some of the features conceived, implemented, and designed by the Mindbowser staff are amongst our most popular features.
Matthew Amsden
CEO, Proofpilot
Mindbowser is one of the reasons that our app is successful. These guys have been a great team.
Dave Dubier
Founder & CEO, MangoMirror
The Mindbowser team's professionalism consistently impressed me. Their commitment to quality shone through in every aspect of the project. They truly went the extra mile, ensuring they understood our needs perfectly and were always willing to invest the time to deliver exactly what we envisioned.
Spencer Barns
Chief Technology Officer, New Day Therapeutics
Kudos for all your hard work and diligence on the Telehealth platform project. You made it possible.
Joyce Nwatuobi
CEO, ThriveHealth