Why do Healthcare Mobile Apps need Governance and a Legal Framework?

Why do Healthcare Mobile Apps need Governance and a Legal Framework?
Healthcare application development services
Modern-day patients get so carried away by the benefits and convenience of smartphone health apps that they don’t think twice before trusting a provider with their sensitive and personally identifiable information. Providers too, do not bother to adopt all the stringent security measures that will protect patient data from unauthorized access, unless they are compelled to do so by regulatory authorities.
Healthcare mobile applications are double-edged swords. On one hand, mHealth apps have provided unthinkable outcomes for patients, doctors, and service providers. But, on the other hand, the usage of smartphone apps in healthcare has made patient data all the more vulnerable to security threats. Healthcare data is the most valuable data on the dark web these days. There have been incidents of health data breaches in recent years that have compromised the records of millions of patients.
This post discusses the reasons why there is an urgent need for regulatory governance and legal frameworks for healthcare app development.

The Current State of Healthcare App Security

 

Medical apps are supposed to follow certain practices, strategies, and regulatory compliances mandated by Government authorities; to minimize the chances of security breaches. But, do all health apps follow standard security practices? Let’s explore!
A distinguished cybersecurity researcher Alissa Knight conducted a thorough analysis of 30 popular smartphone healthcare apps, and the reports are alarming. All of these apps had security vulnerabilities. And, the loopholes identified in 30 apps together can expose the sensitive information of around 23 million users.
Here are some shocking stats of the research study:
    • The API keys of 77% of the medical mobile apps were hardcoded and some of these didn’t expire.
    • 7% of the apps had hardcoded usernames and passwords in the form of plain text.
    • 50% of the API vulnerabilities detected within healthcare would enable hackers to access private and sensitive patient information like personally identifiable data, EHRs (Electronic Health Records) health information, and medical billing details.
    • 100% of the 30 healthcare apps tested were exposed to BOLA (Broken Object Level Authorization) attacks. Such an attack is executed by counterfeiting the user IDs.
    • 100% of the apps didn’t implement the “certificate pinning” protocol that compels a health app to verify the certificate of the server against an authentic and known copy. This made the apps highly vulnerable to man-in-the-middle attacks.

Potential Risks of Hardcoding APIs

 

APIs establish communication between mobile apps and a hospital’s infrastructure, a Cloud service, or a physical server and facilitate data exchange. API keys are used for authenticating the application to other services like payment processing. API keys contain important and confidential information that needs to be secured. And, hardcoding of API keys and other crucial user credentials in mobile/web apps exposes health data to security breaches. According to research conducted by Gartner, by the year 2022 API vulnerabilities will be the major cause of data breaches for enterprise apps.
It’s a common practice of healthcare app developers to hardcode confidential app data directly into the app’s source code and employ obfuscation methodologies for securing the app. However, such security practices are not sufficient to protect health data. Professional hackers can effortlessly break into this data by carrying out the process of reverse-engineering the application. Once the hacker can access API keys, they can use this data to create new software that exactly resembles the actual application; this enables hackers to make arbitrary API calls. Also, the attackers can get access to the app’s back-end infrastructure for interacting with the servers and thereby collect sensitive patient information.

Consequences of Healthcare Data Breaches

 

Healthcare data breaches can lead to hefty fines for the app provider owing to HIPAA/GDPR violations as well as reputational damage for medical organizations.
Patients whose data gets compromised lose their privacy/secrecy and may face discrimination at their workplaces and social circles owing to certain health conditions. Certain businesses might misuse patient data and misdirect them into making unreasonable purchases. Leaked payment information and credentials can result in direct financial losses and exposed personal information may be misused by hackers to cause harm.

What’s the Solution for Healthcare App Security Woes?

 

There are regulatory compliances mandated for health apps like HIPAA, GDPR, FDA, etc. Nevertheless, these mandates fail to cover all areas of health app vulnerability, specifically smartphone health apps. There is an ambiguity concerning the regulatory compliance of mobile health applications put forth by the aforesaid entities. Hence, there is an urgent need for additional rules and regulations and more importantly clarity on mobile health app regulatory protocols. Regulatory bodies of the government and healthcare industry should devise additional guidelines for healthcare app developers and medical app distributers that are not included in regulatory compliances. Such guidance will help maintain parameters like the quality, transparency, accountability, genuineness, and reliability of a healthcare application.

Security Protocols to be followed during Healthcare App Development

 

Healthcare app developers must ensure that data is encrypted during storage as well as transit. This ensures that the health app follows the desired authentication requirements and prevents the device’s chances of being jailbroken. The app must be designed in a way that the server has the information on whether an app running on a user’s smartphone device has been tampered with or not. Besides implementing security measures during healthcare app development, an app must also be monitored continuously after deployment.
Take a look at how the data encryption process works!
Here’s how data is encrypted while being transferred to cloud storage systems!

Source

Practices to Combat Healthcare App Security Threats

 

App Developers must furnish information on the app’s major stakeholders, monetization strategy, scientific sources, privacy policies/practices, consent methods, and so on to government authorities. This will enable the consumers to use healthcare apps securely and protect their privacy while app usage.
As per app store policies and the healthcare industry protocols concerning electronic transactions within an app, the consumers owe a refund from the app owners if the app fails to function as promised. But, not all apps adhere to this business protocol. Moreover, the app subscriptions can be unending unless consciously stopped by consumers. Furthermore, there isn’t any government regulation stating the reduction/regulation of in-app promotions and purchases in medical apps, other than the apps meant for kids.
For this reason, developers must strictly follow the legal protocols regarding consumer advertising and be transparent about the financial expenses that are involved in app downloads and usage. Also, app distributors must mandate time limits on the payment of subscriptions specifically if an app remains unused for a long duration, and activate refund practices in case of any unintended payments have been made by patients. Also, repeated requests for in-app purchases must be avoided particularly in apps that target vulnerable audience groups, like mental health apps.

Legal Framework for Multi-dimensional Assessment of Mobile Health Apps

 

Several health apps have been successful in escaping the attention of regulatory authorities as they are not even considered to fall under the category of healthcare devices. Moreover, even where regulatory frameworks exist, not all healthcare entities follow such regulations and there isn’t any protocol to make sure that all covered entities are complying with established standards. Furthermore, there’s hardly any regulatory guidance for apps implementing complex technologies like AI, ML, etc. as there’s no assessment model that will weigh the risk factors and implementation requirements of diverse digital technologies.
Therefore, international agencies and industry veterans urge the need for a legal framework that mandates a set of regulatory guidelines for classifying smartphone healthcare apps and defining the pre-market route of these apps. There has to be a common legal framework that assesses a health mobile app across multiple dimensions. This framework should be systematic and comprehensive enough to serve a wide range of functions including regulating market authorization/purchasing procedures, the secure usage of mHealth apps, etc.

Final Verdict:

 

The security vulnerabilities existing in modern-day medical apps and solutions and the severe repercussions of a data breach come with a heavy price for patients as well as providers. Hence, there is a dire need for legal frameworks and regulatory governance to protect healthcare data from security threats. Also, the government authorities must ensure that all healthcare apps are implementing the established standards.
If you are a healthcare provider and planning to create a highly functional future-friendly app that adheres to regulatory compliances it’s advisable to look for outsourced assistance. Partner with professional and experienced healthcare app development services in USA . that will provide end-to-end encryption for the sensitive data flowing in the application.

Healthcare App Benefits and Downsides with Ethical Considerations!

Healthcare App Benefits and Downsides with Ethical Considerations!
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Healthcare apps and wellness trackers have gained traction during the last decade. And, the social distancing protocol enforced by the pandemic has accelerated the adoption rate of health apps like never before.
Check out these interesting stats on healthcare application development and usage as per a study conducted by the online research portal sourcetoad.com:
  • Healthcare app development has sky-rocketed with an average of 250 apps launched daily.
  • The market value of medical apps was $40.05 Billion in 2020. According to industry experts, this value will reach $100 billion by the year 2023.
  • Healthcare app categories like telehealth and virtual care have gained more popularity as compared to other categories: 74% of consumers preferred telehealth services and 57% vouched for virtual care apps.
Healthcare apps come with endless benefits to patients, practitioners as well as care providers. But, are all health apps secure and reliable? Health apps have their share of downsides as they handle personal patient information and sensitive medical data. Many are raising questions on the ethical implications of patient data handling processes as well.
Let’s discuss in detail the advantages and downsides of medical apps. Also, learn about the corrective measures and best practices to mitigate the existing bottlenecks in the healthcare app industry.

Healthcare App Advantages

Healthcare App Development

Advanced Patient Services

Telehealth apps offer convenient patient services like online appointment scheduling/rescheduling/cancellation, remote doctor consultations for common ailments, and e-prescription uploading. Advanced communication capabilities like preliminary diagnoses via video conferencing and instant interaction with doctors and other medical professionals using text messages, emails, voice calls, etc. simplifies things for the patient community.
Reminder apps and e-prescription apps facilitate chronic disease management. These apps help patients to stick to stringent medication regimes, set reminders for pill intake, and refill medicines before it runs out of stock. Pharmacy applications enable online medication ordering and door-step delivery.

Clinical Assistance

Clinical assistance apps offer supportive software for medical practitioners. Such apps come with medical calculators, clinical decision-making functionalities, and disease diagnosis assistance functions. Medical professionals can benefit from the various references and databases providing information about drugs, healthcare terminologies, medical conditions, symptoms of diseases, and guides on medication compatibility.

Healthcare Data Storage/Management

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Healthcare facilities need to handle humongous data and hence data management becomes challenging with traditional solutions. However, healthcare apps integrated with EHR (Electronic Health Records) simplify the processes of organizing and managing data effectively. These apps automatically gather and record patient data like personal information, demographics, previous treatment history, allergies, chronic conditions, immunizations, radiology reports, billing info, etc. from different sources. EHR systems enable providers to store medical data in a way that promotes clarity, transparency, and accuracy.
EMR (Electronic Medical Records) stores information about patients’ clinical data, ongoing treatment particulars, etc. Such records help clinicians monitor patients in a better way, assess how patients are responding to a specific course of treatment, and find out the patients who are due for follow-up visits or preventive screenings.
Medical database software converts patient data like healthcare/treatment history, medications, imaging/lab results, procedures, etc. into electronic data. This data is categorized by employing various filters and is stored for internal usage within the facility.

Wellness Tracking: Wearables & Fitness Apps

Fitness applications track the health vitals of users including steps walked, calories burnt, heart rate, water consumption, body weight, etc. using wearable devices. This provides users with quantifiable data on their health parameters and level of fitness. These apps also set fitness goals for users and offer dietary suggestions, encouraging them to practice a healthy lifestyle and adhere to wellness regimes. Users get reminders for activities like drinking water, exercising, and so on. Some fitness apps even make use of intelligent strategies like offering positive feedback and even gamification for motivating users toward a healthy lifestyle. Such apps monitor users’ health vitals and provide a report of their progress periodically. The users can share their fitness-related success stories on social media amongst like-minded people and also opt for joint wellness experiences on social media.
Today, fitness apps are leveraging Artificial Intelligence to obtain the best user outcomes. Machine learning/deep learning algorithms autonomously analyze the healthcare care data collected by the app and the users’ behavioral patterns gathered. This information is then compared with generic human health data contained within a database and matched with the most befitting predefined use case. The algorithms then, draw conclusions and provide users with customized suggestions and corrective measures regarding exercise regimes and diet.

Valuable Informational Resources

Healthcare apps are often a valuable and easily accessible storehouse of informational resources for medical students. Students utilize this information for gaining insights on health conditions, treatment, & medication, preparing notes, and drawing inferences. Moreover, apps offer online study material, lectures, healthcare podcasts, drug references, medical guidelines, healthcare calculators, and even quizzes/tests on medical topics.
Practicing HCPs also benefit from the resources and information provided in healthcare applications. Important case studies can be referred to while treating complicated cases and conducting surgeries.

Healthcare App Downsides & their Ethical Implications

Despite the endless advantages of healthcare applications, this approach involves downsides that raise ethical questions as below:
  • Is there any protocol to ensure whether clinical data is being entered for the right user at all times?
  • Is patient data completely protected from security threats and hackers?
  • Where does the healthcare data get stored and who can access this data?
  • Can the PHI of patients be used by the app owners or sold to unreliable third parties?
  • Can users completely trust the content published and the results generated by healthcare apps?
Let’s explore these aspects in detail!

Data Authentication Errors

Several apps fail to verify whether the clinical findings, e-prescriptions, and other medical diagnoses details are being entered into the profile of the right patients at all times. As a result, the chances of costly errors are quite likely. Such errors may lead to misdiagnosis, wrong treatment/medication, ending up causing harm to patients, and can even be fatal for patients. Furthermore, erratic data may adversely affect clinical research. If incorrect information is used for forming therapeutic deductions, the effectiveness of the research will be hampered and could put billions of investments at stake.

Security Threats

Cyber-security threats like ransomware, phishing attacks, data theft, and unauthorized access can cripple the effectiveness of the healthcare environment altogether. Moreover, data security breaches can lead to hefty fines and penalties for medical entities that have not followed standard security protocols.

Healthcare Data Ownership

Modern-day medical app technologies like AI, ML, etc. can predict user behavior to the minutest detail. And, for obtaining the desired outcome, the relevant contextual patient data including personally identifiable and biometric data has to be fed to the app or system software. Hence, users need to enter personally identifiable data in their profiles and other systems; for reaping the benefits of systems like electronic medical records, biometric scanners, health apps, activity trackers, video doctor consultations, and so on.
Moreover, healthcare data is a valuable source for research teams, analytics identification, and marketers who depend on personal patient data to send relevant promotional offers to their target audiences. As a result, app owners might be tempted to utilize patient data stored in the app as a profitable monetization strategy. Sometimes, data may be sold without the users’ consent in unethical ways to the marketers who offer lucrative deals to app owners.

Clinical Accuracy of Healthcare Apps & the Trustworthiness of App Content

The clinical accuracy and the reliability of quality and scientific correctness of the published content are below average in some healthcare apps and fitness trackers. The anomalies identified in healthcare applications include incomplete information, inaccurate content, variation in content information, improper responses to customer queries, delayed data processing, faulty alarm systems, security gaps in functionalities, and inability to promptly respond to emergency situations. Such inconsistencies may result in life-threatening situations.
Coming to fitness and activity trackers, parameters like step count, health vitals, etc. are not always 100% accurate. This may mislead users in the long run, thereby minimizing the app’s usability.

Corrective Measures for addressing Health App Pitfalls

Data Authentication Protocols

A healthcare app should correctly authenticate the users’ particulars to verify whether the right person is accessing or entering data into a specific user profile. The commonest authentication measures include SSO, two-factor authentication, and implementing technologies like facial recognition, fingerprint readers, etc. within medical apps.
Take a look at how biometric authentication works!
Biometric Authentication System:
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Data Security Practices

Strong encryption methodologies, multifactor authentication, and restricting access to sensitive patient data are some of the data security measures that are adopted by app owners. Proper data usage controls should be followed in case of sensitive data. For example, while handling sensitive medical data, all actions like uploading data to the web or sharing data with external sources should be blocked. Managers are advised to log and monitor the usage and access of healthcare data and conduct vulnerability assessment checks periodically, to identify any weak points.
While exchanging data with connected devices powered by IoT, AI, etc., healthcare entities must adhere to these security practices. All the security patches must be installed and the connected devices must be updated regularly. During data exchange with connected devices, all the unnecessary features must be disabled so that only the required data is captured.
Coming to users’ mobile devices; data should be encrypted in transit as well as during storage, robust passwords must be used, and there should be a way to remotely lock stolen devices. Users should be encouraged to update their OS whenever required and install solutions for mobile security and device management.
Segregating the wireless network of your healthcare organization into sub-networks for different groups of users like staff, patients, visitors, third-party partners, etc. is an effective security practice. This allows you to protect your private network from external environments. It is also necessary to backup data regularly on cloud-based systems, for retrieving sensitive data if damaged or lost. The app owner must also check the security readiness of business associates like insurance agencies, pharmacies, etc. with whom the app exchanges medical data.

A Hack-Proof System & Continuous Monitoring

Healthcare providers must ensure that the patient data collected, stored, and used by them is protected from privacy issues, unauthorized access, and unscrupulous practices. So, developers of Healthcare app in USA must create hack-proof software to protect PHI (Protected Health Information).
Internal healthcare networks within an organization are easy to protect as these are mostly intranets that are isolated from other networks. The real challenge is protecting medical data collected by health apps that function across multiple open networks and are accessed from various locations. Also, the existence of several interconnected systems within a healthcare environment complicates developers’ tasks. And, even if the system is end-to-end encrypted, security threats cannot be ruled out. The physical device used to operate the software may lack privacy or safety measures that are usually adopted while developing the application. Also, security practices may become obsolete after a certain time owing to constant technology changes.
Therefore, building a hack-proof software system is not enough. You also need to continuously monitor the app for security loopholes post-deployment and upgrade the app’s infrastructure and security practices as per the changing market requirements. You must necessarily adhere to security compliances like HIPAA mandated by authorities.

Medical App Assessment Protocols

Certain mandated assessment protocols are being introduced to examine the quality and security of healthcare software. The rating scale evaluates healthcare apps based on parameters such as app aesthetics, user engagement, the app’s usability quotient, feature set, and the correctness of the information provided. For instance, MARS is a protocol for assessing mental health apps.

Closing Thoughts:

Healthcare mobile app development is a complex, time-consuming, and costly affair. It involves adherence to a host of regulations, specifications, third-party integrations, and compliances. Also, post-deployment maintenance and support is an essential prerequisite for the smooth functioning of the app, rolling out updates, resolving bugs, and eliminating security woes. Such requirements can be too much of a challenge for newbies and start-ups. Therefore, it’s advisable for healthcare providers to partner with an experienced healthcare application development company in USA that will provide end-to-end services including post-launch support.