Digital Health is a $350B market globally, set to nearly double in the next five years. Despite the 2020 boom of telemedicine app development services, there are many more great ideas for products and opportunities to enter the market.
And the investors’ attention is spreading across various healthcare areas too.
While, according to the analysis of search terms, patients have historically expressed the most interest in screening and diagnostic tools—most notably, online symptom checkers.
Healthcare tech is a vulnerable industry that makes your work valuable and is in real demand now. However medical app development is different from the rest. Here we tried to collect the distinctive peculiarities of medical software.
Healthcare is filled with bureaucracy. The legal and clinical safety is far more important than the tech.
You may have the best intentions to help others with their health problems and make their lives easier, but wouldn’t necessarily know which regulation your healthcare app needs.
And it is not always straightforward. For example, an app that offers to calculate medicine doses or timings, or diagnose injury or conditions is defined as a medical device. They require a CE quality mark, according to the UK government regulator the MHRA.
What rules and laws your product should observe depends on the geography of your market. Some of the most widespread topics in the area are privacy and security. Other issues may vary from product to product.
Data breaches have already posed a lot of issues on the financial front, impacting the healthcare industry. According to IBM’s report, the data breach hit hard in 2020, costing $7.13 million annually, where 80% of the information resulted in the exposure of personal information of the customers.
Here are regulations of several countries, that health tech companies should follow if their app specially designed for the corresponding regions’ markets:
1. The United States: Health Insurance Portability and Accountability Act (HIPAA).
The regulation applies to apps that transmit PHI (like medical records or appointment dates) and generally would not include apps designed for use solely by individuals. So, you will need developing a HIPAA compliant app.
2. The European Union: Data Protection Directive 1995/46/EC and e-Privacy Directive 2002/58/EC. In the EU, private data is anything that may identify the person, so e-mail, phone number, name in combination with street address, etc. Especially if that may be combined with information about why the person is using the health tech product.
3. Canada: Personal Information Protection and Electronic Documents Act (PIPEDA)
4. The United Kingdom: Data Protection Act
5. Asia: Personal Information Protection Act (PIPA).
6. Singapore: Personal Data Protection Act (PDPA)
Other types of regulations your healthcare application may face by the example of the US:
- Food and Drug Administration (FDA), which regulates food, drugs, and medical devices. It strictly regulates and requires agency approval for apps that specifically conform to a definition of medical devices. It implies “mobile medical apps” that control or transform a medical device and deal with diagnosis and treatment recommendations
- A product may be subject to regulations promulgated by the Federal Trade Commission (FTC). The FTC deals with deceptive or unfair business practices
- Consumer protection
- Licensure rules. For example, “telehealth” or “teledoc” companies. Most states in the US deem physicians to be practicing in the place where the patient resides and accordingly require licensure in that region. Companies offering patients online access to licensed healthcare professionals all over the country may require licensure requirements in all 50 states.
Accounting for the legal and regulatory compliances from the beginning helps you to avoid massive changes and incur significant costs afterward. So, it makes sense to have a lawyer or hire a legal company to help you with legal operations.
Check whether you can break into the insurance market
If you can get your medical service or app covered by an insurance company, it will exponentially grow the number of potential users. Mostly, however, an insurance company’s decision to cover a new health tech product will depend upon each applicable state’s laws.
Apple and Google rules
Google said that it reviewed all apps on a «case-by-case basis» and Apple says in its developer guidelines that medical apps «may be reviewed with greater scrutiny». Apple also says apps that claim to take X-rays or measure things like blood sugar levels using data taken by the sensors on the device are banned.
Developers with domain knowledge?
You will be required to hire such healthcare developers to build your product from scratch and to be in the «core» product team. In this case, healthcare knowledge will help a programmer to work more closely and rapidly with the users, and business people (product managers). Without understanding this complex domain, it is difficult to provide good solutions to some of the health problems.
Keep in mind, that specialized developers are more expensive and for some apps, it is enough to hire just an experienced developer and provide him with detailed requirements.
It’s highly recommended to have a co-founder with a medical background or at least a healthcare consultant. If the professional experts associated with the healthcare solution aren’t knowledgeable enough in the field, the chances of product failure will be high. Moreover, some regulations and standards require health tech products to be back-upped by experts. So, keep the expert panel qualified, renowned, and recommendable.
Mistakenly pressing a wrong button in the medical app can at least lead to the incorrect filling of the patient fields, which can significantly complicate the work with data and even lead to tragic outcomes.
On the other hand, a well-thought-out interface helps to streamline communication between medical workers and patients and make healthcare processes cost-effective.
You should also remember about accessibility. In one of our previous blog articles, we said that product accessibility is critically important in the healthcare industry. Some of the reasons are: an app might be used by a sick person with a temporary or permanent disability; there can be cases of emergency.
Compatibility and interoperability
Healthcare apps should be developed as per the targeted hardware usage context (e.g. eco-system of the healthcare organization). What devices your target audience will use for the app? Young patients usually prefer mobile devices, medical workers — tablets, and elderly people — computers.
Interoperability refers to the ability to effectively link and organize applications, computers, and systems. Hospital personnel may use a wide range of medical tools and devices: dermatological sensors, programming applications, functional control systems, and EHR solutions, etc.
Because the future is uncertain, successful players must be nimble, flexible, and fast to adapt to current times. In order to have a chance of successfully staying on top in this dynamic industry, players must also consider their ability for quick action when needed.