Some of the Healthcare apps, eHealth, mHealth apps in the US have to comply with HIPAA which is a set of standards meant to protect the sensitive health information of patients. If these rules are violated, the concerned entities may face severe repercussions.
Here is one such real-case scenario of a leading provider of insurance in the US, Anthem, Inc.
In October 2018, Anthem, health insurance provider was charged a heavy penalty for neglecting security and privacy rules set by HIPAA. It started with a small phishing email and later led to a massive data breach. There was an aggressive cyber-attack by the hackers that may have exposed the protected health data (PHI) of approximately 79 million patients which further lead to the risk of identity fraud.
Also, the infuriated patients sued Anthem and won a settlement of $115 million. Not only this, but Anthem was charged by the U.S. Department of Health and Human Services Office for Civil Rights (OCR) at $16 million. Had the company followed HIPAA compliance, they could have saved millions as well as their brand image.
If such a large corporation could go through such devastating attacks and penalties for violating HIPAA rules, smaller practices need to be all the more cautious.
Why is HIPAA Compliance so Important/Crucial?
Today, thousands of health apps and software are being used by patients as well as doctors. A tremendous amount of sensitive health and personal data continually flows through them. So, the owners of telemedicine apps, hospital bodies using the healthcare apps, healthcare IT services developing healthcare apps carry a huge responsibility to protect this data. In case they fail to do so, it could lead to data breaches, healthcare frauds, identity thefts, blackmail, etc. So, the concerned entities must abide by HIPAA guidelines. Here are some key advantages to following them:
- It fosters an environment of compliance.
- Helps to educate the staff about the right way to handle sensitive data and practice strict security controls.
- Enables to proactively assure that electronic PHI is being accessed, transmitted, stored, or shared appropriately and securely.
- Simplifies administrative healthcare functions while improving the efficiency of the entity.
- Helps in the transition from paper records to the digitalization of health records or other forms while reducing manual errors.
- Helps to gain patients’ trust which also improves brand reputation.
- Provides a competitive edge.
- Helps organizations to avoid expenses for add-on security measures.
- Facilitates enhanced operational efficiency in healthcare practices.
What kind of Health Data falls under HIPAA Compliance?
Any medical app involves crucial medical data. HIPAA’s primary focus is on securing this data i.e. PHI. PHI is categorized majorly in two parts- health records/data and personally identifiable data. As per the Department of Health and Human Services, PHI’s personally identifiable data includes 18 classes namely:
- patient names;
- geographical data including state, city, country, exact address, pin code, etc.;
- dates like their admission dates, discharge dates, birth or death dates, etc.;
- contact numbers;
- fax numbers;
- medical record numbers;
- social security numbers;
- health plan beneficiary numbers and names;
- account numbers and other credentials;
- certificate/license numbers;
- vehicle identifiers and serial numbers;
- device identifiers and serial numbers;
- IP addresses;
- web URLs;
- biometric identifiers like fingerprints and voice prints;
- photos or images of faces and any comparable images;
- Any other unique identifying numbers, codes, or characteristics.
What Entities are covered under the HIPAA Privacy Rule?
The below-mentioned individuals and organizations willing to develop healthcare apps must adhere to HIPAA-compliant structure and its guidelines.
Healthcare Providers: Any healthcare service provider, big or small, that requires electronic processing or transmission of medical data for certain transactions like requests for authorization, claims, inquiries for eligibility, and other such transactions comes under this category. These include hospitals, or individual practitioners like doctors, dentists, psychologists, etc.
Health Plans: These comprise of entities that pay the cost of healthcare expenses, for instance, insurance providers, health maintenance organizations (HMOs), employer-sponsored group health plans, multi-employer health plans, government- or church-sponsored health plans, etc.
Healthcare Clearinghouses: These are the entities that act as middlemen between the healthcare service providers and insurance companies. These process nonstandard data they receive from a healthcare organization into a standard format or vice versa.
Business Associates: The entities that store, collect, process, or transmit PHI on behalf of all the aforesaid covered entities.
How to Make your Medical App HIPAA Compliant?
Any entity that wants to build a HIPAA compliant medical app or software must do the following:
- Ensure the integrity, privacy, confidentiality, and availability of all ePHI i.e. electronic protected health information.
- Detect probable threats and safeguard the information in all the ways possible.
- Protect against probable impermissible disclosures or accesses
- Certify compliance by the staff
Also, here is a list of security measures to be taken for protecting and controlling access to health data in a medical app.
Limit Access of data: Limit the access to sensitive data by providing a unique ID to concerned authorities and also the patients. This helps in tracking the activity being carried out in the application.
Entity Authentication: Verify the person/entity trying to access the data with the use of passwords, biometrics, PHI PINs, token, digital signatures, etc. The app must provide access only to authenticated users.
Encryption of the data: Ensure that the PHI data in healthcare apps is encrypted before storing it on the servers and databases. Use tools like BitLocker, File Vault, etc for encrypting the data. Encryption greatly ensures data integrity by protecting it from hackers. Without decryption keys, the hackers would just keep struggling around without any results.
Using Secured protocols: The data transmitted over networks and between the tiers of a system, should be channeled through HTTPS protocol that encrypts data using SSL and TLS. If PHI data has to be sent through email, then HIPAA compliant email services should be used.
Ensure Data Backup: Backup of all PHI is a must. It must be stored in various locations so that in case of a system crash or database corruption or a fire in a data center, the data remains intact.
Discard PHI data after use: Any sensitive data should be permanently destroyed if not needed anymore. In case it remains in your systems, scanners, biomedical equipment, memory cards, network cards, etc., it is vulnerable to threats
Automatic Logging-off: In case of inactivity, the app having PHI should terminate the session automatically. The users will need to log-in again by re-entering the password.
Monitoring and Auditing of data: Monitoring and auditing of the data in healthcare apps must be conducted regularly. Every time a user logs in or out, the details must be recorded. The data can be monitored via hardware, software, or other procedures. Activity on PHI data can be recorded using a log file or log table in the database.
Extra Mobile App Security: The security measures in mobile apps like screen-lock, remote data erasing, full-device encryption, etc. must be suggested to the users of the app to enhance the security of the data. These can’t be forced on the users though.
Unauthorized access of PHI data from healthcare apps will lead to huge fines that can cost you a fortune but HIPAA compliance can save you from these penalties. HIPAA security will assure the auditors that you have done enough to protect medical data from phishing, social engineering, breaches, etc. Though adhering to HIPPA seems cumbersome, yet they guarantee future-proof apps, secured software solutions, infrastructures for a booming healthcare market.
Has this blog provided you with the required insights about HIPAA rules and HIPAA compliant apps? Please let us know through your comments.
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