There has been a rapid, significant, and continued advance in scientific discovery and technology proliferation to support health care in new ways in recent years. Technology is being integrated into the health sector to provide improvements in the quality of healthcare delivered to patients, and that’s what we call “Health Tech.”

When addressing Health Tech, an array of elegant legal questions arises, put, such as follows: (A) what are the regulatory issues of Health Tech? (B) what are the challenges that Health Tech startups face?


(A)  What are the regulatory issues of Health Tech?


1- The emerging gap between Health Tech and applicable laws

Suppose a comparison is to be made between the emergence of new technologies and the laws intended to regulate health technology. In that case, a wide gap will appear between technological advancements and the mechanisms present to regulate them.

On the first hand, laws and regulations are considered to be crafted slowly and deliberately. On the other hand, health care technologies evolve rapidly, which, therefore, addresses the issue and the difficulty of applying these standards laws to the latest developments and innovations.

2- Balancing between citizens’ protection and technology innovation

With the proliferation of Health Tech, countries worldwide are revamping their regulatory oversight of medical technologies.

Today, regulators face a significant challenge, they must balance between their charge to protect citizens, and the advancing innovation in new technologies and businesses, resisting the urge to overregulate.

The laws and regulations must protect citizens and ensure fair markets while letting innovation and businesses flourish by providing them with a fair amount of flexibility and no limit for their innovations.


(B)  What are the challenges that Health Tech startups face?


1- Use of data in machines

One of the main challenges that startups could face when talking about Health Tech is using people’s personnel information and applying adequate measures to ensure their protection.

In general, people are very cautious about giving out sensitive personal information. With Health Tech, the cautiousness and the worries are far more. This arises because the sensitive information acquired from patients is present in a technology creation, which makes it more exposed to security breaches known as cybersecurity. This is why Health Tech startups should identify how they need to use the data they collect and ensure that they have taken adequate measures to protect it.

Besides, the data taken and used by the startups should only be to the extent needed to accomplish the intended goal and not more.

Startups should consider drafting and customizing high-end privacy policies to ensure it has taken serious measures. These measures protect highly sensitive information and, therefore, drastically limit the danger of security breach and their liability.


2- Health privacy and security

Many rules are mainly aimed at regulating access to health information and ensure its security. For example, in the European Union (EU), the General Data Protection Regulation (GDPR) came into force in 2018 to regulate the use of data in general. Besides, Data Protection Authorities (DPA) has issued fines for GDPR violations committed for health data issues, such as data breaches, insufficient data security practices, etc.

In the United States, the Health Insurance Portability and Accountability Act (HIPAA) was designed to provide privacy standards. Those privacy standards protect patients’ medical records and other health information provided to health plans, doctors, hospitals, and other health care providers.

Health Tech startups must be compliant and abide by the present and applicable laws.

The question and speculation reside on whether these applicable laws provide the full protection of Health Tech privacy. These laws have certain loopholes that need to be addressed and regulated, which is to be further discussed.