One could not notice the upward tendency in the med-related application release in the contemporary digital marketplace. Indeed, the mHealth market is projected to reach <a href="https://www.businesswire.com/news/home/20220428005996/en/Global-mHealth-Market-Forecast-Report-2021-2028-Adoption-of-Internet-of-Medical-Things-IoMT-Development-Opportunities-in-Emerging-Countries---ResearchAndMarkets.com">$410.39 billion by 2028</a>, up from $70.83 billion in 2021.

However, between 2009 and 2021, there were <a href="https://www.hipaajournal.com/healthcare-data-breach-statistics">4,419</a> healthcare data breaches involving 500 or more records, according to the HHS' Office for Civil Rights.

Moreover, in 2019, one study published in the National Library of Medicine found that <a href="https://pubmed.ncbi.nlm.nih.gov/30894349/">79% of med-related apps</a> share data without the patient’s approval.&nbsp;

At the same time, according to Healthcare Digital, <a href="https://www.healthcareglobal.com/technology-and-ai-3/most-healthcare-apps-have-weak-security-report-finds">more than 80%</a> of all Covid tracking apps were found to have leaked data, with about 70 percent of medical apps tested having at least one high-level security vulnerability.&nbsp;

It turns out that the release of more and more applications in recent years has compromised the safety of patient medical data. This is exactly what the medical sector should have avoided. This is why there are now several regulations that companies must comply with when developing a medical solution targeting both patients and HCPs. If you ignore certain security standards, you will begin to lose the trust of your users, or, the worst potential consequence — you and your startup could be in serious legal jeopardy.

Depending on the location where the data will be transmitted and stored, medical apps may be under various standards of healthcare regulations.

The Health Insurance Portability and Accountability Act or HIPAA is a U.S. law passed in 1996 that guarantees the confidentiality of medical data. It regulates how companies must ensure the security of patient data and how it must be kept and passed on between different systems and devices. That's why if a mobile health-related solution collects, processes, stores, or passes on any Protected Health Information (PHI), its stakeholders must ensure HIPAA compliance. To guarantee the protection of patients' medical data, the product's stakeholders (developers, among others) can adhere to the following points:

A typical medical application can include a bunch of features. Of course, most such solutions should stick to HIPAA rules, but some features are considered “gold standard”. Their implementation requires HIPAA compliance to ensure the app's security and build user trust. Such features can include:

Digital health apps in the EU fall under the jurisdiction of the General Data Protection Regulation or GDPR, which was adopted in 2018. The main purpose of this regulation is to protect any private information of EU residents. This information refers not only to the first name, last name, identification number, etc. but also to data concerning the physical or psychological state of an individual. This regulation has a “far-reaching impact” and is not limited to online medical solutions.

Therefore, if your medical startup aims to collect, store and process EU residents' data, make sure it is GDPR compliant. GDPR-compliant applications must provide users (patients) with the following options:

The Personal Information Protection and Electronic Documents Act regulates the storage and handling of Canadian residents' data. Its functionality and purposes are similar to the GDPR. In other words, the act is intended to protect confidential user data, including names, identification numbers, medical records, etc.

The Data Protection Act or DPA was adopted in the UK in addition to the GDPR. In essence, the act has similar aspects of regulation as the GDPR but is limited only territorially (applies to UK users). Thus, the regulation aims to ensure the protection of individuals' private data through compliance with certain rules on the part of the healthcare organization when interacting with that data.

In general, a program designed to handle the personal data of UK patients must conform to three data protection laws:

Health Level Seven provides some flexible practices that can be applied across med-based systems. Practices are defined as certain rules that allow information to be disseminated and processed between different medical systems. In brief, this set of international standards defines how medical data is properly shared and managed across multiple healthcare-related data hubs.

HL7 involves addressing the following issues:

Since the HL7 standard is considered cumbersome to work with, there is now an alternative — Fast Healthcare Interoperability Resources (FHIR). It essentially has the same functionality but provides more flexible and simplified ways to operate it.&nbsp;

These standards are the most important if you are dealing with storing, handling, and transmitting medical data. However, other rules are desirable to follow to make your application as secure as possible. For example:

It is a coding system for the classification of diseases, disorders, and injuries, which is mainly aimed at creating a unified healthcare infrastructure for the seamless exchange of data between different medical institutions and HCPs.&nbsp;

This is a system of standards that defines how medical providers should properly share the personal data of their patients.&nbsp;

Thus, the choice of rules to follow when developing a product is determined according to various factors. However, the most important of these is how the data will be transmitted and stored. In other words, for which countries the solution is oriented.

I have a HealthTech startup where we connect users to medical specialists close to their location. We are now looking to integrate patient records into the system so that doctors can view their medical history before a consultation. Are there any regulations to follow for this?

What are the regulations for building a healthcare app that deals with patient data?