Understanding the Ethical and Legal Nuances of Digital Dentistry

Even as little as a decade ago, dental visits were probably not the most comfortable of experiences for patients. Sitting for long periods with the mouth open, messy impression pastes and multiple trials meant that a visit to the dentist wouldn’t have been at the top of the patient’s list of happy activities.

It wasn’t easy for the dentist either. Patient work could be time-consuming; trials and fittings relied heavily on the patient’s ability to fully cooperate not to mention the hopeful faith in the patient’s ability to fully visualise their future smile and embrace the outcome. Fast forward ten years and the landscape has changed considerably. Dentistry has seen the biggest leap in its operations thanks to the arrival of digital dentistry.

As a practising dentist, you’ll know all about the key applications and benefits that digital dentistry has brought to many clinics. Perhaps you’ve already invested heavily in technology yourself and who would blame you because the advantages of a fully digitised workflow far outweigh the cost. However, what lies on the other end of ‘tech’ are real humans with emotions and a need for privacy and protection. This is why it’s important to understand that while digital applications in dentistry are a huge plus, they come with their own set of ethical and legal implications.

Here’s what you need to know…

Are Your Digital Devices and Software Compliant?

Even as far back as 2016, an article highlighted how the MHRA (The Medicines and Healthcare Products Regulatory Agency) was tackling counterfeit and non-compliant dental devices in the UK. The agency had seized over 12,000 dental devices coming from places like China and Pakistan, many of which had been sold on places like eBay, Amazon and Alibaba and were not “fit for purpose”. This included X-ray machines that emitted high levels of radiation and digital equipment that didn’t conform to UK/EU regulation standards.  As such, the MHPRA advised dentists to remain vigilant when purchasing digital devices and software and to note that they must be EU-compliant – notified by a UKCA or a CE marking.

But there’s more…

How Much Should You Trust Your Digital Technology?

Relying solely on digital technology for examining radiographs, carrying out virtual treatment plans or assisting with treatment coordination means that dentists can leave themselves open to legal issues.  For example, if mistakes occur and clinical results deviate significantly from what’s expected or are harmful to the patient—the practitioner will hold the final legal responsibility.

Essentially…

• Your team: the hygienist, assistant and technician must read, follow and understand the manufacturing process of the digital device but not rely solely on its findings.
• You must also, have the Statement of Manufacture (SoM) at hand. this document outlines key details about the product and the manufacturer. Patients have a legal right to receive this document, and failure to provide it is considered a criminal offence.
• Finally, it’s crucial to follow any standard operating procedures and maintain proper documentation and referral protocols in the process.

What about Medical Liability and Malpractice Risks?

Most digital tools use mathematical algorithms to facilitate treatment plans,  virtual mock-ups or smile previews. However, while technically correct, without extensive human involvement like dentist-based clinical modifications, they can produce unsatisfactory results and digital errors.

So, when implementing new digital technology, it’s important to address  the following:

• Training: Ensure the team and consultants are well-versed in the nuances of the diagnostic tool or technology – E.g. what they can and cannot do.
• Building confidence through experience: New clinicians should gain confidence through experience and hands-on evaluation rather than relying solely on technology.
• Avoiding legal issues: Proper training helps prevent legal complications that could arise from misuse or lack of understanding and awareness.

Then There Are Intellectual Property Concerns

Who takes ownership of the digital scans and treatment designs you make? This raises an important legal question.

Always read and understand the user manuals, licensing agreements and intellectual property rights when using third-party software to avoid potential disputes. Clear policies on data ownership should be established within dental practices.

Finally, Let’s Not Forget  Cybersecurity and Data Protection Laws

Patient data protection is a key concern in digital imaging. The GDPR, effective May 2018, requires patient consent for collecting, storing, and sharing dental records—in dentistry, this especially holds for digital imaging practices using 2D and 3D X-rays. Digital imagery shared between clinicians and laboratories must be securely transferred to protect privacy. There is also a risk of manipulating digital records and malpractice.  Any data breach can result in severe legal consequences, including fines and reputational damage. To reduce the risk of digital image manipulation, you must:

• Meet cybersecurity regulations
• Understand the manufacturer’s implementation policies for strong encryption and access controls.
• Select companies with native integration policies to your practice management system; this ensures easy and smooth accountability.

So, that’s the legal aspect of digital equipment and software but what about the more complex ethical dilemmas?

Exploring The Ethical Aspects Behind the Use of Digital Dentistry and Strategies to Ensure Compliance

The advances in areas like CAD/CAM, digital radiography, patient record management, and teledentistry demand a complete know-how of the ethical principles that govern them. This ensures a safe and compliant dental practice.  A 2020 study, for example, aligned the ethical challenges of incorporating digital technology in dentistry to four key principles: autonomy, non-maleficence, beneficence, and justice. 

Key questions included were:

• Does the treatment respect patient autonomy? 
• Is it beneficial or harmful? 
• Is it fair and equitable?

To explain further, let’s look at each factor:

#1 Patient Autonomy and Informed Consent 

Both autonomy and consent are fundamental rights of a patient. As digital tools become integral to diagnosis, treatment planning and therapy, practitioners must communicate their use and involvement. Dentists must fully explain to the patient why, for instance, they are using a 3D scanner and how it benefits the treatment. They should also discuss where and how the data is stored or shared and talk about any available alternatives. This gives the patient the freedom to make an informed decision and/or consent where necessary.

#2 Data Privacy and Confidentiality

It’s also the dentist’s responsibility to safeguard patient information. Before investing in a digital dental device, it’s important to understand and verify the manufacturer’s cybersecurity measures to prevent unauthorised access and data breaches. Compliance with data protection regulations like HIPAA (U.S.) and GDPR (EU) is a ‘must’ in maintaining trust and confidentiality in digital dental practise.

#3 Is the Tool Necessary or Beneficial To The Patient

Digital tools like AI and 3D scanners are routinely integrated into most treatment plans. These include virtual dental implant mock-ups, Invisalign ClinCheck and smile simulators.  To cite an example, let’s consider digital prosthodontics. Aesthetic treatments can raise ethical questions, such as –

• Does the patient truly benefit from them? And …
• Does he or she need it?

Essentially, dentists should weigh up whether the treatment suggested by the treatment planning software (in this case, the enameloplasty of natural teeth or multiple teeth preparations for smile makeovers) is…

(A)  Beneficial to the patient, and

(B)   Needed.

Overtreatment, driven by the dentist’s financial needs and the influence of diagnostic tools over the patient’s best interests, is ethically wrong and could be grounds for a malpractice lawsuit.

Navigating The Legal And Ethical  Landscape Of Digital Dentistry – The Key Takeaway

The key factor in all of this is balance! Digital dentistry is a unique investment that can position your practice as an industry leader. In fact, failing to use digital work streams can in some instances, hold you back. Instead, by balancing innovation with integrity and compliance, it’s possible to harness digital advancements responsibly, ensuring both patient trust and high-quality care.

Are you a new dentist building your practice, a seasoned dentist looking to make your dental office tech-savvy, or are you facing challenges with digital workflows? Whatever the case, implement digital dentistry ethically and legally with suggestions and guidance from expert advisors at DDS. To learn more about the best practices for the adoption of digital dentistry the right way, feel free to connect with us.