Does your Mobile App require HIPAA Compliance?

Does your Mobile App require HIPAA Compliance?
HIPAA compliant apps
Healthcare data has always been vulnerable to threats like data leaks, security breaches, unauthorized access, etc. The emergence of healthcare mobile apps and the current trend of digital healthcare record maintenance and data transfer; have worsened this possibility. Despite offering advantages like convenience, speed, and accuracy; digital healthcare data is prone to cyber-attacks.
Hence, the governing authorities across the globe have established rigorous standards for all medical entities that collect, process, and store patient data. The Health Insurance Portability and Accountability Act, commonly known as HIPAA, is one such compliance regulation mandated for US-based healthcare bodies that utilize healthcare software solutions.
Developing a HIPAA compliant app involves additional costs as extra security layers need to be integrated within the app. And, data breaches due to HIPAA violations may result in hefty fines or even criminal charges depending upon the severity of the breach. Hence, medical bodies and app development services must be well versed with the specific guidelines that determine whether a particular healthcare mobile app or software needs to comply with HIPAA regulations. This post has consolidated all relevant HIPAA-related information to guide you through HIPAA standards and also mentions which entities are covered under the HIPAA rule. Read along to know whether your healthcare mobile app falls under the category of applications that require HIPAA compliance.

HIPAA: Inception and Governance

The HIPAA act was rolled out on 21st August 1996 and had been updated several times since then. The most noteworthy update was the one declared on 14th April 2003.
The Department of Health and Human Services (HHS) regulates the HIPAA rule and the Office for Civil Rights (OCR) enforces this rule. OCRs provides routine guidance on new issues cropping up in the healthcare industry and investigates the common instances of HIPAA violations.

Why is HIPAA Compliance Important?

HIPAA (Health Insurance Portability and Accountability Act) is a set of interlocking regulatory standards that establish how businesses should use, store, and disclose patients’ data while maintaining the privacy and security of that data.
The prime objective of HIPAA is to prevent the unauthorized and unlawful exposure of sensitive patient information. As such, HIPAA confers patients certain rights regarding their healthcare data. It also offers federal protection to this data by defining rules concerning administrative setups of medical facilities and the technical safeguards to be used by them. The reason is that if confidential patient data is leaked, there would be absolute chaos resulting in the failure of the entire healthcare system. Therefore, all medical organizations handling PHI (protected health information) must adhere to HIPAA guidelines for protecting the privacy & integrity of patient data and ensuring data security.

How does HIPAA Function and what are its Offerings?

HIPAA defines and controls how a patient’s PHI is collected, stored, and managed by doctors, healthcare facilities, and other stakeholders of the healthcare sector. This PHI can be physical records or electronic records maintained by a healthcare application. HIPAA regulates physical and electronic standards for protecting the privacy of an individual’s data.
Coming to offerings, HIPAA focuses on the confidentiality and privacy of healthcare data. The most notable offerings are providing insurance portability to citizens, setting standards for handling medical data, maintaining the efficiency of healthcare data-related operations, and ensuring data security.

HIPAA Regulations: Categories

Healthcare app development services

HIPAA Privacy Rule

The HIPAA privacy rule determines which data is considered PHI and which entities will ensure whether the PHI is disclosed lawfully or not.

HIPAA Security Rule

The HIPAA security rule deals with electronic information and establishes guidelines to be followed for maintaining the privacy and security of the PHI. This rule categorizes the data protection methodologies into three different segments – physical, administrative, and technical. Physical security standards cater to actual devices, administrative standards deal with training & access control, while the technical category revolves around data.

HIPAA Omnibus Rule

The HIPAA Omnibus rule was added to apply HIPAA compliance for business associates of covered entities. The rule also mandates the rules pertaining to BAAs. BAAs or Business Associate Agreements are contractual agreements that must be signed and agreed upon before sharing or transferring any data containing PHI or ePHI. Such an agreement is executed either between any covered entity and a business associate or between two business associates.

HIPAA Breach Notification Rule

This rule defines standards to be followed by covered entities and business associates in an event of a data breach involving the ePHI or PHI. The rule states various requirements related to breach reporting. Data breach incidents must be promptly reported to HHS OCR. The breach reporting protocols are defined as per the magnitude and the type of the data breach.

Which Elements of the Healthcare Industry are covered under HIPAA Compliance?

PHI (Personal Health Information)

As defined by the US law authorities, all personal or health-related information of a patient that was created, disclosed, or used during the course of diagnoses or treatment; falls under PHI. PHI includes the data used/stored by a healthcare facility, covered entity, or a business associate of a covered entity for identifying a patient’s identity, and determining their present medical condition, payment transaction data, or provisions of medical care. PHI contains a patient’s demographic details like name, address, contact number, date of birth, geographical location, facial pictures, social security number, insurance information, financial details, and healthcare records like medical bills/e-mails, lab test/scan results, pharmaceutical prescriptions, etc.
In a nutshell, PHI is personally identifiable information that is present in a patient’s healthcare records and the treatment-related data interactions happening between doctors and healthcare professionals. The fact that a patient has received services from a covered entity and the date on which the medical service was availed is also considered PHI.

Covered Entities

According to the Department for Health & Human Services (HHS), covered entities include healthcare clearinghouses, health plans, and the healthcare service providers that electronically transmit any kind of transaction-related medical information.

Business Associates

Any establishment/individual that collects, maintains, stores, or transmits PHI on behalf of a covered entity falls under the category of business associates even if they do not directly deal with healthcare. A business associate that works along with a covered entity also needs HIPAA compliance. Determining whether your mobile app is a business associate or not; may become tricky at times. So, it is advisable for you to consult a legal expert if you have the slightest confusion.

Does your Healthcare Mobile App require HIPAA Compliance?

Now comes the million-dollar question; “Does my healthcare mobile app need to be HIPAA compliant?” Let’s explore!

Identifiable and non-identifiable data

The process of determining whether or not your mobile app needs to comply with HIPAA rules is quite tricky. This is because data like a person’s DOB or zip code may seem least likely to be misused, but such data can be utilized by resourceful hackers for causing harm to individuals because these are identifiable data. As such, app owners must be able to distinguish between identifiable data and non-identifiable data.
For instance, popular fitness applications like Fitbit, Wahoo Fitness, Runkeeper, MyFitnessPal, etc. do not need HIPAA compliance because they track & handle non-identifiable data like heart rate, calories burnt, diet consumed, blood glucose levels, distance covered, steps climbed, BMI, and weight changes. Such data, if stolen cannot be used for carrying out malicious practices. So, this type of data is categorized under consumer health information, and not PHI. Furthermore, the aforesaid apps do not share the stored data with any third-party provider like doctors, medical professionals, or insurance agencies. And, since this data is not being transmitted, app owners do not require encrypting data by adding layers like cipher suites or TLS (Transport Layer Security).
mHealth and telemedicine apps have to be HIPAA compliant as they collect and transmit identifiable patient data. These apps connect patients with doctors for consultation, diagnoses, and treatment. For instance, mHealth/telemedicine app users are asked a plethora of questions concerning their health for narrowing down the symptoms, and then this information is used for finding the most suitable doctor who can begin their treatment. Moreover, patients receive treatment through remote monitoring via video conference calls, text messages, virtual doctor visits, and discussion forums. Therefore, such apps need to store and transmit data like e-prescription, personal identification data, treatment history, appointment information, etc.

Healthcare e-mails and Push Notifications

Generally, e-mails are non-compliant as they are usually unable to encrypt the contents. However, e-mailing information that contains PHI is a HIPAA violation. Hence, if PHI-related information has to be sent through e-mails, you must choose a HIPAA-compliant e-mail service provider for such communications.
Push notifications sent to users via mobile apps may violate HIPAA regulations. This is because, the content sent may be visible publicly on the screen, even when the smartphone device is locked. So, it’s advisable to avoid including any PHI-related data in the push notification content.

API and Database Calls

If your app depends on the data from the covered entity like a practitioner’s office and isn’t HIPAA compliant, then these covered entities will not be allowed to grant access to your app to execute API or database calls. Also it will not be able to read any information contained in the database. This will limit the app’s functionality considerably.

Concluding Lines:

If your healthcare mobile app needs to be HIPAA compliant, every element of the app including external tools or sensors has to comply with HIPAA rules. HIPPA compliance adds multiple security layers to your mobile app like administrative safeguards, technical safeguards, physical safety measures, documentation safety measures, and breach notification regulations. This increases the complexity of mobile app development and chances of misses are likely.
So, it would be a great idea to seek technical assistance and partner with experienced healthcare app development services. These companies can help you build the most robust HIPAA-compliant apps that function without any operational glitches.

Essential Features to include in your Pharmacy Management System!

Essential Features to include in your Pharmacy Management System!
Pharmacy app development services
Digitalization has made its mark in every sub-domain of the healthcare sector, and the pharmacy industry is no exception. The advent of smart Pharmacy management systems has eased countless operational woes for pharmacy business owners. So, what is a pharmacy management system? Well, it’s a software system that has been programmed for carrying out various functions that are needed to operate a pharmacy business.
Versatile pharmacy software works wonders for pharmacy owners as well as consumers. A sound pharmacy solution automates and simplifies pharmaceutical functions like medication dispensing, identifying drug over-usage, etc. resulting in smart pharmacy management, reduced errors, and enhanced patient services.
Now the question that arises in your mind is; “What features to include in sound Pharmacy software?” This post provides you with detailed insights on the essential features to integrate within a modern-day pharmacy management software system. Let’s get started!

Pharmacy Management System: Essential Features

Pharmacy app development company

A Centralized Database for Data Storage

pharmacy management system
Data plays an important role in the pharmacy sector. Hence, a pharmacy business must ensure the safe and secure storage of data as well as a productive data processing mechanism. A pharmacy management system offers a centralized database for storing medicine-related data securely so that data is never lost and can be retrieved easily whenever needed. The system software also manages transaction records.
This feature adds to the patient’s convenience as it simplifies data search, ensures secure data access, and facilitates information collection about medicine availability. Providers reap the advantages of auto-generated drug reports, the need for a lesser workforce, improved communication between the pharmacy staff, real-time visibility into inventory and sales through advanced data analytics, and enhanced decision-making. The best part is that this centralized database is highly effective for businesses with small databases as well.

e-Prescription Generation

The usage of e-Prescriptions or electronic prescriptions is gaining momentum these days. Here’s how the process of e-prescribing functions?
A prescription is created electronically and then, transmitted from the prescriber to the pharmacy. Usually, a CPOE (computerized provider order entry) system like an EHR is employed for this purpose. The doctor creates a medication order using a CPOE system and sends it to the patient’s pharmacy through a secured connection. Once, the e-Prescription is generated, the pharmacy tracks the order and communicates whether that order was received and filled. Such communication between two systems is made possible with the usage of SCRIPT, a special XML-based standard. However, any type of prescription creation software needs to be Surescripts certified. So, healthcare entities generating ePrescriptions have to either get their system certified or pick pharmacy app development services that support Surescripts certification.
The e-Prescription feature saves paperwork, reduces the chances of human errors, and rules out the possibility of the prescription being lost or stolen. Moreover, as doctors can send medication refills directly to the pharmacy, medicines are speedily dispensed. Furthermore, patients availing of e-Prescription enjoy benefits like getting notified if they had missed picking up their order, creating order renewal requests with just a few clicks, and many more.

Synchronization with Real-time Information

Pharmacy App Development
An ideal pharmacy management system need to consider situations like technical glitches and system crashes where the data can get lost in a split of a second. For this reason, the system must synchronize with real-time data including price-related updates, inventory updates, and auto-program updates. This feature promotes real-time interaction and hence, allows pharmacists to help patients with insurance forms as well.

Analytics & Report Generation

Pharmacies interact with countless patients daily. This data concerning patient interaction is immensely beneficial as it helps pharmacy businesses in understanding the requirement, planning the future course of action, and improving business strategies. This data can also be useful while carrying out audits, inspections, or certification processes in the future.
A pharmacy app records data of each patient interaction, stores it in the pharmacy information system, and generates classified sales reports that are organized product-wise and category-wise. These reports calculate the factors that determine medication sales and provide crucial insights into the business activities of a pharmacy service. Service providers can effortlessly identify purchase patterns like which consumers frequently visit the pharmacy for medicine refills and what kind of medicines they order, which medicines are in demand at a particular season, etc. This way, pharmacy wholesalers/vendors can stock medicines as per the consumer requirement, be sufficiently equipped to handle the demand surge for specific drugs during a particular season like the flu season, and devise profitable marketing strategies.
Implementing an ERP system will help in handling monitoring & analysis activities and statutory audit checks.
Reports reveal a great deal about the current performance metrics of a pharmacy, the areas of improvement for boosting the ROI, and the budgeting roadmap that need to be followed. Data analytics reports also help pharmacy owners to detect suspicious patterns and check anomalies within their operations. Overall, reports lead to more informed decisions and increased revenues.

Necessary Integrations

An effective pharmacy management system must be able to integrate with other healthcare systems to facilitate the seamless flow and consistency of medical data. Let’s take a look at the commonest integrations needed. Interaction with a medical facility’s EHR enables the pharmacy solution to access the treatment records, as well as the medical history of patients, and integration with the logistics system helps in timely medicine distribution. Pharmacy software also needs to integrate with billing systems, hospital management systems (HMS), relevant external platforms, etc.

Dashboard

An in-built dashboard that provides actionable insights is of prime importance in a complex pharmacy management system. The presence of a dashboard helps pharmacy providers track the amount of medicines that are produced and the amount of wastage as well. Dashboards offer KPIs (Key Performance Indicators) through focused charts and reports. The KPI reports are based on the service provider’s key goals and display only those pieces of data that the pharmacy owner requires to fulfill a specific objective they have set. Therefore, this data not only boosts data analysis but also enhances business productivity and collaboration.

Support for SMS Alerts and Multi-store/Multi-location Management

The feature supporting SMS and notification allows pharmacists to get intimated whenever any patient’s medication is about to expire and they need a refill. Pharmacy staff then notifies patients via text messages before their prescriptions run out and patients can inform the pharmacist that they need a refill by just responding to the message received. Also, pharmacists can continuously stay in touch with consumers through status updates, thereby elevating the patient experience.
If pharmacy software offers multi-store and multi-location support, owners can manage the functioning of several stores at different locations. Pharmacy providers can view the exchange of electronic data concerning sales, returns, stock levels, etc., and also calculate the profits made by the entire pharmacy chain.

Medication Order Management

Medication Order Management
A pharmacy management system makes use of reordering points or the pharmacy-defined par levels for generating automatic orders. Thereafter, it calculates the number of items required for raising the stock level; it then adds the required quantity of items to the order. An EDI (Electronic Data Interchange) methodology is used for delivering the orders.

Managing Medication Expiries

Pharmacies suffer losses on account of expired drugs. Since pharmacies buy medication from whole sellers in bulk, every medicine has a different expiry date and MRP. Therefore, it becomes challenging for pharmacists to keep track of the expiry dates of each medicine. As a result, several drugs get expired while lying on the shelves of pharmacies without the knowledge of pharmacists and the pharmacy owners come to know about it only after the date of expiry, leading to medication wastage.
A pharmacy management system having the expiry management functionality notifies the owners about the expiry dates of medicines well in advance. This provides pharmacy owners the option to either sell those medicines to customers or return them back to the supplier. This way, wastage of medicines and financial losses can be avoided.

Management of Medication Re-ordering

The medication re-orders management feature provides critical insights that help pharmacists to stay informed and organized. Right from establishing re-order points, to finding out when to replenish the stock, and determining which product fares better in the inventory, this functionality does it all.
Pharmacists have to pre-define the maximum and minimum stock level margins, and then feed this data into the system. Now, the system alerts them whenever the stock level goes below the minimum point prompting them to reorder. It also suggests the best purchase option to the user, as per the programs offered by nearby suppliers, and recommends purchase schemes that offer super-saving options.

Module for User Management

A user management module helps pharmacy providers effortlessly set access-related preferences for different groups of users in order to reserve certain features for specific users. This includes restricting access to certain features for different audiences. The functions of this module can be segregated into two categories – Administrator User and Administrator Authentication User.
The Administrator User Module empowers the user to control the buying-selling process and carry out actions like viewing the medication stock available in the pharmacy; enlisting the medicines they need, tracking the pharmacy map, etc. This category of user management regulates the daily processing of stocks and sales.
The Administrator Authentication User Module allows the authenticated users to view every process including the transactions, sales reports, etc., manipulate the medication lists as well as stocks, track their everyday activities, and generate daily accounts using the multi-site software.

Inventory Management

Pharmacy Inventory Management
The module for managing stocks in the inventory proves very handy to pharma owners. This feature integrates an EDI or APIs to order data. The offerings include classification of inventory products based on their categories, receiving as well as generating automatic orders, drug dispensing, managing out-of-stock products, and providing inventory counts and print labels. The software generates inventory reports that enable the suppliers and pharmacists to identify the best-selling products and figure out which drugs are affecting the distribution and ordering processes.

Sales Management Modules

Billing and accounting tasks in a pharmacy are often prone to errors. Nevertheless, an efficient pharmacy management system offering the sales management feature can optimize such tasks and eliminate the chances of errors. Here, the system automates the tasks of receiving orders, executing payments, and generating receipts; then add these tasks in reports.
The sales management module correctly matches the product codes to formulate their accurate prices, resulting in error-free billing. POS or point-of-sales module offers patients a wide range of options for making payments and completing returns.
Some billing modules offer electronic signatures and options for managing patient data and loyalties. And, if patient data is connected with billing histories, smart analytics utilizes this data for creating real-time financial reports and provides recommendations on improving patient experience.

Managing Prescriptions and Doctor Commissions

Difficulty in reading prescriptions by the patients and pharmacists has always been the source of confusion and errors in drug dispensing. The usage of a competent pharmacy management system resolves such woes as the data is directly entered by the doctor and electronically stored within the system.
The system also tracks pharmaceutical transactions to identify which practitioner has created a particular prescription or which medical representative is involved in a specific transaction with the pharmacy regarding medication sales. Such software instantly calculates the doctor/MR commission generated by the pharmacy for each medicine sold out and each prescription involved.

Compliance with Standard Regulations

Compliance with standard regulations mandated by authorities is essential for any pharmaceutical practice. So, a pharmacy management system must be compliant with the latest security practices and evaluation parameters mandated for activities like e-prescription generation, medication ordering, medicine refill, etc.
For instance, DSCSA (Drug Supply Chain Security Act) prohibits US pharmacies to dispense fake medicines and thus protects the citizens from counterfeit medication. Canadian pharmacies have to comply with the regulations defined by NAPRA and European pharma stores need to verify the authenticity of each medicine by employing a point-of-dispense validation system.

Bottomline:

I hope this post was informative and has given you a clear idea of which features to add while executing the pharmacy app development process. However, you need to pick the features as per your requirement and business objectives.
If you are a novice in the software development arena, it would be advisable to team up with skilled healthcare app developers or a reliable IT firm that has extensive experience in pharmacy app development. Your partner will take care of your pharmacy software development project right from app ideation to deployment.