Healthcare is a new hot topic in software development, which means that user experience designers are getting more requests for designing and conducting research for medical applications. Working on something that will help patients manage a chronic disease, administer the correct dose of medication, or communicate more effectively with their healthcare provider can be very rewarding. However, there are many unique issues to be aware of before starting the design and development of a medical application or device.
The design of a medical product may fall under various regulations that can impact the design, implementation, and record keeping decisions related to the product. Not being aware and informed about these laws and regulations before starting design may delay getting your product to market. It may also result in spending additional time and money retrofitting the product. Worse, regulatory bodies may prevent you from launching the product. These regulations generally fall into two categories: one details the handling and protection of personal information about patients; the other ensures that patients, caregivers, and medical staff are not harmed when using a medical device.
In the United States, patient privacy is protected by the Health Insurance Portability and Accountability Act (HIPAA). The European Union’s equivalent is the Data Protection Directive. Some European countries have additional requirements. For example, France requires that personal data be stored on servers physically located in France. In the U.S., patient safety is regulated by the Food and Drug Administration (FDA), which regulates everything from blood glucose meters to allergy medications. The European Union, Japan, and most other countries have similar regulatory agencies and laws, although the degree to which they impact product design varies by regulatory body. (See the sidebar for more details about these laws.)
Impact of Privacy Laws
Much of the impact of privacy is on the development side. For example, selecting hosting servers where the data is encrypted. This prevents administrative staff and other unauthorized users from viewing patient records. However, there is often a UX impact as well. These laws require limiting access to information only to users who actually need it. This might require creating user accounts and levels of access, usually role-based, to limit access to different users. For example, the billing department may need to know what services were provided for a given patient, but don’t need to know the diagnosis. These design issues need to be taken into account in the initial designs, and throughout the product development lifecycle.
Example: access to patient data
A recent client didn’t want the added expense of building and maintaining individual user logins. They knew their product was going to be used in medical offices where administrative staff is usually responsible for entering patient data but the doctor is required to provide the final sign-off. The client wanted to have the administrators sign in using the doctor’s login. The problem with this approach is that U.S. privacy laws require that detailed records be kept of who has accessed and changed patient records. While the client acknowledged that some offices may choose to have multiple users use the same login to access the accounts, privacy regulations preclude designing this as the default behavior. An option that would allow each user to have their own account with a separate login and password has to be provided.
Protecting Patient Safety
When it comes to protecting patient safety, the rules and regulations of the FDA, EU, and other regulatory bodies often overlap, but are not identical. In general, all safety regulations aim to prevent patient harm due to misuse of a product. A lot of the requirements for implementation revolve around patient risk. Will a particular feature cause harm? If so, what design changes are required to mitigate the risk?
Many of the regulatory requirements around designing and building a safe, risk-free product follow user experience best practices. Identifying every target audience is required, similar to UX personas. Also, it is important to identify each task a user might perform. Here the emphasis is on identifying risk, not usability problems, but a detailed analysis could identify both at the same time. User and design evaluation is also a major component of the regulations. In fact, to obtain FDA approval you must provide results of at least one round of user testing, usually called human factors testing (although it is highly recommended to do more). The difference again is an emphasis on risk. But a good, usable design will, in most cases, also reduce the likelihood for user error and thus risk.
Example: recommended dosing application
Another client recently had an application which provided a dosing recommendation to patients. It then required the patient to enter how much of the medication they had actually taken. The default value indicating the actual dose taken was initially set to zero. During the evaluation process, it was discovered that the zero was confusing patients. The confusion arose because the zero conflicted with the actual recommendation displayed elsewhere on the screen, making it appear that the application was providing two values, the actual recommendation and a recommendation of zero (or do nothing). It also caused some patients to incorrectly enter the dose they had actually taken, impacting future calculations. The default display was changed to blank. This reduced the risk of potential harm to patients by eliminating the confusion between the recommended dose and entering the actual dose they had taken. This made it clear that no value had been entered by the patient, and ensured that future recommendations would be calculated correctly.
In the same application, users have the option to link their mobile app to an online web account. This is a complicated process and does not follow a standard method. Many users were unable to complete this task. While the feature may be annoying and difficult to use, it is not harmful. Linking with the website is not required to use the application properly. Since it does not pose a medical risk to patients, regulatory bodies are not likely to be concerned by it. However, if this were to impact the effectiveness of the application, then it may be found to be important.
Conclusion
There are many considerations to take into account when designing medical products, some of which are not relevant when designing other types of applications. One important area is the impact of the environment under which the application will be used. This can include extreme noise and light; for example, an operating room or hospital patient rooms. A lot of medical equipment has alarms. How do you make sure your product doesn’t add to the noise, resulting in alarms that end up being ignored? How do you differentiate between minor problems and critical issues? If the product is for personal use by a patient, can it be used discreetly to avoid embarrassment to the patient and thus increase compliance? Differences in reimbursement models between healthcare systems can also impact the adoption of the product. A product covered by health insurance in one country may not be covered elsewhere. How patients are taught to treat their illness may also have an impact. Is there a global standard for care? Even within the same country, there can be regional variations in care and variations between large cities and small towns.
There are many more areas to consider when designing an application for healthcare. By addressing the issues above and keeping privacy concerns, patient safety, and risk in mind, you will be on your way to designing a successful medical application.
[bluebox]
U.S. Laws that affect heathcare design
HIPAA – Health Insurance Portability and Accountability Act Ensures patient information is protected. The laws include physical limitations organizations must undertake to ensure privacy, as well as electronic ones. Details are at: http://www.hhs.gov/ocr/privacy/index.html FDA – Food and Drug Administration The government body that regulates all health-related applications, medications, and devices. The FDA requires basic steps for software design and development:
- Define intended use, users, environment
- Identify use-related hazards
- Estimate and prioritize use error risk
- Implement risk controls
- Validate safety of use
A final round of summative testing is done on the finished product, where all life-threatening risks are expected to have been mitigated. Some of the important guidelines and requirements documents:
- Draft Guidance for Industry and Food and Drug Administration Staff -Applying Human Factors and Usability Engineering to Optimize Medical Device Design, June 22, 2011
- ISO/IEC 62366:2007 Medical devices — Application of usability engineering to medical devices
- FDA’s Design Control Guidance for Medical Device Manufacturers AAMI/ANSI HE75:2009
[/bluebox]对医学应用或产品执行调查或用户体验设计，需要了解适用于这些产品的政府法律和法规。必须维护患者隐私，并确保使用此类产品的患者和健康保健专业人员的安全。在整个用户体验设计和评估流程中，如果不遵守这些法规，可能会导致额外的开发时间和成本。更糟糕的是，监管机构可能会拒绝产品的最终审批。 文章全文为英文版
의료 애플리케이션이나 제품을 위한 연구나 UX 설계를 하려면 그 제품들에 적용되는 정부의 법과 규정에 관하여 알아야 합니다. 환자의 프라이버시를 지켜야 하고 환자와 제품을 사용하는 의료전문가 모두의 안전이 보장되어야 합니다. UX 설계와 평가과정에 있어서 이런 규정을 준수하지 않으면 개발 시간과 비용이 더 들 수도 있습니다. 더 심각한 것은, 규제기관이 제품의 최종승인을 거부할 수도 있습니다. 전체 기사는 영어로만 제공됩니다.
Conduzir pesquisas ou projeto de experiência do usuário para aplicativos ou produtos médicos exige conhecimento sobre as regulamentações e legislações do governo que se aplicam a esses produtos. A privacidade dos pacientes precisa ser mantida e a segurança dos pacientes e dos profissionais de saúde que usam o produto precisa ser garantida. O não cumprimento das regulamentações durante todo o processo de projeto e avaliação da experiência do usuário pode resultar em aumento de custo e tempo de desenvolvimento. Além disso, órgãos reguladores podem impedir a aprovação final do produto. O artigo completo está disponível somente em inglês.
医療用アプリケーションまたは製品の調査やUXデザインには、こういった製品に適用される法令への理解が求められる。患者のプライバシーは常に保護されなければならず、製品を使用する患者と医療従事者の安全も確保しなければならない。UXデザインと評価プロセス全体を通じてこれらの規制に従わなければ、開発にかかる時間と経費が増加する可能性もある。悪くすれば、規制当局が製品の最終的承認を保留する事態さえ考えられる。 原文は英語だけになります
Dirigir investigaciones o el diseño de la experiencia del usuario para aplicaciones o productos médicos requiere un conocimiento sobre las leyes y regulaciones gubernamentales que se aplican a estos productos. Debe mantenerse la privacidad del paciente y debe garantizarse la seguridad de los pacientes y los profesionales de atención médica que usen el producto. No seguir estas regulaciones durante todo el proceso de diseño y evaluación de la experiencia del usuario puede resultar en un aumento de tiempo y costes de desarrollo. Lo que es peor, los organismos de regulación podrían paralizar la aprobación final al producto. La versión completa de este artículo está sólo disponible en inglés
