Tags – Legal Issues in Digital Health Solutions
As technology advances and more people move to digital solutions, the health industry is quickly following suit.
In fact, a recent study by PwC found that 78% of healthcare providers plan to invest in or expand their digital health services in the next three years.
This is great news for patients and providers alike, as digital health solutions offer many benefits over traditional methods: patients are being treated remotely via mobile doctor apps, symptom-checking bots are triaging patients and providing tailored advice, and new remote consultation and tracking solutions are entering the market at a rapid pace.
However, with this progress comes new legal challenges. In this blog post, we will discuss 5 of the most pressing legal issues in digital health solutions.
1. Data Protection
Organisations that use patient data will have to identify whether they are a processor or controller, and adhere to any relevant GDPR regulations.
There may be tough GDPR problems to tackle, such as consents, security measures, and data transfer limitations.
During the pandemic, the UK’s Information Commissioner’s Office released advice stressing that data protection does not prevent organisations from sharing information or changing their operations – data protection is about being proportionate.
However, the GDPR is only one piece of the puzzle when it comes to using patient data.In the UK, the common law duty of confidentiality between doctors and patients may need to be considered; this limits healthcare professionals’ ability to exchange information.
There are also the National Data Guardian’s Data Security Standards and the UK’s National Health Service’s (NHS) detailed information governance standards to consider.
2. Registration Requirements for Regulated Activities
There is no telemedicine-specific legislation in the UK, resulting in a more digital health-friendly environment than some other countries.
However, your business may still be required to register particular regulated procedures with the UK’s Care Quality Commission (CQC), such as triage and remote medical consultation.
The registration procedure is lengthy and includes a thorough application process, an evaluation by the CQC, and a CQC inspection.
Providers of licensed services must also adhere to ‘fundamental standards’ and guidance on topics such as patient mental capacity and assurance of patient identification.
3. Liability
It’s wise that digital health providers consider and mitigate several potential avenues for liability claims. This includes:
- Strict liability under the Consumer Protection Act 1987, which implements the EU Product Liability Directive
- Fault-based liability for negligence, such as medical negligence claims
- Contractual liability (depending on the contracts entered into)
- Exposure to liability under the MDD and MDR
There is quite a high, and ever increasing, appetite for medical negligence actions in the UK.
4. Market Access and Reimbursement
In the UK, the NHS is by far the largest customer of healthcare products and services.
The NHS, however, may be a difficult customer to deal with – processes are decentralised and complex, and they differ from one NHS trust to the next.
As such, defining the ways that governments might use electronic health technologies in a post-implementation context will help us better understand how they affect public money and procurement rules.
The complexities of contracting with NHS bodies, including the monetary thresholds for contracts which may necessitate public tenders by hospitals, potential commercial models of supply, and reimbursement.
5. Medical Device Regulation
There’s a chance your digital health solution will be regulated as a medical device in the EU if it has a medical function.
There are some exceptions, but in most cases, a company should conduct an evaluation to see whether this is the case and to determine the classification of any potential medical device.
The UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) is laser-focused on prioritising any technologies that can assist in the fight against COVID-19, so any digital health tool that may aid in this will almost certainly be given high priority in reviews and approval processes.
In certain situations, the MHRA may allow manufacturers to market non-CE labelled goods in the interest of public health protection.
Final Remarks
There’s a new direction to make it simpler for commissioning bodies to embrace digital healthcare technologies, and for inventors to facilitate this.
The National Institute for Health and Care Excellence (NICE) has created an evidence standards framework for digital health technologies that addresses efficacy and economic impact criteria.
The UK has also established a ‘Code of conduct for data-driven health and care technology’ to outline the government’s standards for those developing, deploying, and utilising data-driven technologies in the NHS.
As with the MHRA, NICE is placing a high value on COVID-19, therefore any digital health solutions in this area are likely to be given special attention by NICE during evaluation and approval procedures.
For more information, please get in touch today.
In the meantime, take a look at our Court of Protection solicitors here.
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