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Over the years, there has been an unprecedented growth in digital health used in healthcare delivery in the GCC states. However, the COVID-19 Public Health Emergency (PHE) has accelerated digital transformation in healthcare more than any other industry.

With the increase in demand to meet the needs of patients and monitor their health, technology companies are coming up with new technological advancements in the diagnosis and treatment of inpatient management. Inventions such as electronic prescriptions, electronic medical records (EMRs), and healthcare management and information systems (HIMSS), among others, have changed the way healthcare is delivered to patients.

However, like any other rapidly growing industry, health technology is facing dramatic legal changes; for example, in 2019, the President of the United Arab Emirates issued the Health Data Act, which aims to regulate the use of technology in the health sector. Going forward, tech companies in these spaces should expect increased legal scrutiny from various regulators.

Here are some legal considerations in the field of health technologies.

1. Regulatory Bodies

Companies developing medical devices incorporating artificial intelligence (AI) and machine learning (ML) must comply with the new approaches of the Ministry of Health and Prevention (MOHAP) to regulate health technologies. Companies must provide their proposals and any other critical information on any of the machines to be installed and used in healthcare.

Recently, a blockchain-based health data storage platform was introduced to help MOHAP deliver smart health services to patients efficiently. Guidance from regulators will help companies developing medical devices clarify to what extent products will be regulated.

2. Fraud and abuse

As healthcare operations embrace technology, everyone involved, from providers to vendors and payers, must adopt key practices to prevent or minimize fraud and abuse. All the models involved in digital delivery create different types of risks depending on the legal theories, which the Department of Justice (MOJ) pays close attention to.

The MOJ examines different health care providers, for example those who provide electronic medical records. Organizations must provide consumers using medical insurance cards with relevant knowledge on how to protect themselves against questionable actions.

Companies must also have appropriate monitoring and enforcement strategies in place to root out fraud and abuse, according to Saudi Arabia’s fraud and abuse regulator.

3.Antitrust

Balancing data sharing and data blocking is one of the biggest antitrust concerns in digital health. Excessive data sharing in digital health is much more complicated than in any other industry. While some companies may welcome the idea, data sharing in digital health can lead to regulatory issues.

Limited sharing can make a supplier dominant in the market; although this is not necessarily a bad thing, it creates different antitrust issues, for example, abuse of dominant position. Abuse of dominance is considered an antitrust violation, which results in legal action and heavy fines, among others.

4. Data Privacy

Healthcare professionals must protect the confidentiality of patient medical data at all costs, and any data breach must be reported immediately and appropriately. Relevant companies need to comply with data protection in the right way to avoid liability when handling sensitive patient data.

All of the following issues should be considered when processing sensitive data:

  • Seek consent in data processing, especially in clinical trials
  • Ensure that data subjects are informed of secondary uses of data, for example in the case of research
  • Healthcare providers and pharmaceutical companies impacted by data breaches assigned compliance responsibilities
  • All consent must be explicit, specific and informed

5. Product Liability

Product liability is a type of law in which the law holds the producer (manufacturers, suppliers, retailers, and distributors) liable for any defect in the product that causes injury to patients. In digital health, many people can be held liable in the event of a dispute; these people include:

  • data provider
  • software developer
  • Device manufacturer
  • The company responsible for marketing

The Consumer Protection Association of Saudi Arabia aims to protect the interests of consumers and safeguard their rights. Anyone who fails to adhere to established professional standards, requirements and ethics must face disciplinary action.

6. Employer liability

As more and more digital devices are adopted by employers, it will be necessary to analyze the data collected by all these devices. Data analysis carries its own set of risks for the employer; for example, if a patient suffers harm due to foreseeable problems that have not been resolved, the employer may be held liable.

A foreseeable problem depends on what the employer knows or does not know. In order to protect the employer, digital health providers must not disclose personal health data to the employer.

7. Ethical use of artificial intelligence

With the rise of technology in healthcare, there is more emphasis on the use of AI. Several guidelines have been produced over the years to aid in the evaluation and implementation of digital technologies in the healthcare industry. However, even with this, there have been instances of discrimination and bias caused by AI systems.

As a result, there have been growing calls to make these systems more transparent. Companies need to adapt and implement good governance when it comes to acquiring and implementing AI systems in healthcare.

8. Cybersecurity

Every day, organizations become vulnerable to cyberattacks that threaten confidential information and disrupt day-to-day operations. Hospitals, especially private hospitals, store a lot of information that is worth a lot of money in the wrong hands.

All healthcare organizations that access patient data must comply with all established laws, including the proposed Personal Data Protection Act (PDPL). Ensuring that digital health solutions comply with applicable laws is one way to reduce and prevent cyberattacks.

The healthcare industry is rapidly adopting technology to deliver smarter and faster healthcare services. However, technology comes with great risks that affect everyone involved. Regulators are increasingly focusing on the health technology space and new products being introduced into the healthcare industry.

Even though there are various opportunities for healthcare delivery models, responsible companies should exercise caution and ensure that they comply with rules and regulations in all GCC states.