We have seen a phenomenal hype of mobile apps in the Healthcare industry. From efficient patient management to better diagnosis, #mHealth apps have shown a great significance all around in this domain. Efficient use of mobile apps in healthcare provide better informed, faster clinical decisions to doctors and help patients to manage their Health outside of the clinical care.

Healthcare apps are whooping with 4 million apps installed per day, by 2017 mobile healthcare (mHealth) sector is projected to be 26.56 billion dollar industry. There are more than 97,000 health and fitness related mobile apps currently available on Google Play and Apple App Store!

Healthcare apps come with lots of regulations in order to adhere protection and privacy of patient information. Below I am going to give you an insight how you should develop a healthcare app which follows regulations and guidelines of “Health Insurance Portability and Accountability Act- HIPAA”.

Significance of Healthcare Apps

Under the one roof of mobility, mHealth encompasses a wide range of products and services. Irrespective of time and location it gives cutting edge advantages to providers to access patient’s clinical data, provide consultation and latest offerings. Healthcare apps also help patients to get in touch with doctors when they are not in the hospital.

mHealth offers the wide range of healthcare solutions ranging from remote diagnostics and patient care, chronic management, clinical information systems to data gathering for public health, hospital administration, and supply chain management.

mHealth has the latent to be a keystone of healthcare infrastructure. The below facts and figures (Obtained from various trusted sources) illustrate the present and future values.

mHealth transforming to clinicians

• Better quality and consistency of medical care are the #1 reason for physician adoption of mHealth.
• 69% of medical practitioners take leverage of mobile technology to view patient information, including pathology lab details.
• Everyday 50% Physicians use mobile technology for healthcare.
• A survey by deviceMedDataGroup shows 61% of physicians browse specialty specific and clinical content on a mobile
• According to Research Now – 86% of healthcare professionals believe that health apps have a significant role in understanding their knowledge of patients’ conditions.
• 43% of healthcare organizations use mobile technology to send secure text messages internally and 32% use mHealth to securely text message patients.
• mHealth reduces 60% paperwork time, increases 29% patient consultation time and allows to check 2 more patients daily.

The value of mHealth for patients

• Per Patient there is significant improvement in communications by 30 minutes– HFMA
• mHealth Routine users focused on improving physical and social wellness are more than 20% likely to be thriving than those who don’t use mobile apps– Gallup
• Members who used a mobile app for their healthcare plan in the past year has 108 points (out of 1000) higher than those that didn’t —D. Power
• According to FISCO, 80% of global smartphone users are interested in using their smartphones to communicate with health care providers.
• 61 percent of obese or overweight patients leverage of a mobile app to communicating with a doctor.
• A report by Wellness Connected shows that 56% of US Adults like to track their health with associated health devices that automatically connect digitally and send information to doctors and other healthcare professionals.
• Manhattan Research reveals over the age of 55 Years, 50% of tablet users use tablets for health care

mHealth is Real Hotspot for Investors

• With an annual growth rate of record 47.6% the mHealth global market is projected to reach $49.12 billion by 2020.
• In 2013, wherein digital health funding was $2.2 billion, has been doubled to $4.7 billion in 2014
• In 2014 Ventura Capitalists (VC) have funded total $1.2B to Mobile health companies
• The fastest growing market for mHealth is monitoring services is expected to play the dominant role over other healthcare categories.
• Managing Chronic disease is the largest contributor to the mHealth monitoring services

What is HIPAA

HIPAA is an acronym for Health Insurance Portability and Accountability Act. To ensure the confidentiality, integrity, and security of protected health information (PHI) the HHS (U.S. Department of Health and Human Services) issued a set of rules and regulations.

These set of rules sets the standard for protecting sensitive patient data and gives instructions about how the data will be collected, stored and distributed to address the privacy, use, and disclosure of the health information for individuals.

Organizations/companies who deal in protected health information (PHI) must comply all the required physical, network, and process security measures stated by HIPAA.

Does Your App Need to be HIPAA-compliant?

Going to develop a healthcare app? Be very careful, though all health-related apps need not be HIPAA-compliant. In fact, most apps in the market today are not, but if your app falls into the category which has to be HIPAA compliance, it may cost you a lot!!

If your app is used to record and share patient information with a covered entity in any way, it must be HIPAA-compliant.

On the other hand, your app probably does not need to be HIPAA-compliant if it performs tasks such as the following:

Here are some cases so you can easily determine whether or not your app have to be compliant

• If your app helps user to record their weight, watch/learn exercise routines
• Provides medical reference to its users
• Made for browsing illness information to general users
• Defines symptoms for different illnesses conditions or diseases
• Help to make and manage diet plans etc.

Besides medical professionals such as doctors, nursing staffs, contractors if the app has to be used by average people then does not need to be HIPAA-compliant.

There are some exemptions for healthcare professionals too. For example, consider an app which helps medical professionals to obtain disease information not required to be HIPAA-compliant. But, if the app is made to record disease information about a specific patient, it has to be.

Developers Guide for mHealth Development:

Compliance Checklist: What You Need To Do

Here I am going to give a quick overview of the various elements required for HIPAA compliance. Please note it should not be considered a complete, to avoid any unpleasant situation we recommend that you consult an attorney or “HIPAA compliance officer” to determine the compliance specific feasibility with a particular solution you are going to build.

Please Check  HIPAA Security rule and the HIPAA Privacy Rule.

Who HIPAA applies To – Covered Entities and everyone touching PHI

Covered Entities” include:

• Health plans- Individuals or groups who are stakeholders in healthcare related money transactions.
• Health care clearinghouses: An entity which is involved in the healthcare data processing from various organizations.
• Health care providers: Clinical Care, services, or supplies related to the healthcare of an individual, including (1) preventive, diagnostic, therapeutic, rehabilitative, maintenance, or palliative care, and counseling, service, assessment, or procedure with respect to the physical or mental condition, or functional status, of an individual that affects the structure or function of the body; and (2) sale or dispensing of a drug, device, equipment, or other item in accordance with a prescription.

The HITECH advisements to HIPAA stretch HIPAA compliance requisites to all Business Associates of Covered Entities.  Further, the Omnibus rule requires that all Business Associates of Business Associates to withal be compliant.  I.e. everyone in the chain of companies from the Covered Entitles onward needs to be compliant!  Even law firms need to comply with HIPAA were they contact PHI.

Note that individuals do not have to be HIPAA compliant if they fall in above category.  So a patient need not to be compliant in interacting with his doctor; but, the doctor has to be compliant when they revert back.

Addressable vs. Required

There are two popular terms in HIPAA: ‘required’ and ‘addressable’. 

There are two popular terms in HIPAA: ‘required’ and ‘addressable’.

Required (R) is the mandatory standard means it must comply with HIPAA.

The addressable (A) term implies with an organization, which should read and interpret each HIPAA standard separately and deal with each piece independently in order to meet the requirements of the organization.

HIPAA Security Standard reveal a “technology-neutral” approach. There are no underlined technological systems to employ and no specific recommendations.

How do you know what you need to address? There is a simple rule of thumb – if there is “risk” you have to “address it”.

Ignorance is to no excuse in case of HIPAA requirements, addressable or required, is “willful negligence”.  In cases of violation, there are hefty penalties in cases of willful negligence with a maximum penalty of $1.5 million per violation.

HIPAA Executive Requirements

Parties who seek HIPAA Compliance should consider:

• Risk Analysis: (R) Carry out a thorough risk analysis and get it documented to analyze how PHI is being used, stored and underline all possible situations of HIPAA violation.
• Risk Management: (R) Implement sufficient security measures to diminish risk factors.
• Sanction Policy: (R) Deploy sanction policies for employees who fail to comply.
• Information Systems Activity Reviews: (R) regularly examine and audit system logs, inspection trails, etc.
• Officers: (R) Designate HIPAA Security and Privacy Officers
• Employee Oversight: (A) Set up procedures to authenticate and handle workforce working with Protected Health Information (PHI), and mechanism for editing (granting and removing) PHI access to employees.  Accessing to PHI must end with employment termination.
• Multiple Organizations: (R) Take complete security measures so parent, partner or contractor organization cannot access PHI without having authorization for access.
•  ePHI Access: (A) Implement straighten security measures for giving access privilege to ePHI including what data, document or services, and systems have to be given access to ePHI.
• Security Reminders: (A) There must me a system in place to give periodic reminders about security policies to employees.
• Malware Protection: (A) Take a safeguard against malicious software detection, reporting, and neutralization.
• Login Monitoring: (A) Monitor logins logs to systems and reporting of inconsistencies.
• Password Management: (A) Ensure best practices for creating, changing, and protecting passwords of individual users.
• Response and Reporting: (R) Identify, document, and respond to security incidents.
• Contingency Plans: (R) There should be legitimate and substantial backup option should be available for restoring any lost data of ePHI.
• Contingency Plans Updates and Analysis: (A) There must be a system, procedures in place for intermittent testing and revision of valuables plans.
• Emergency Mode: (R) Build up systems to empower continuation of basic business forms for assurance of the PHI electronic ensured protected data while working in disaster mode
• Evaluations: (R) Perform the periodic audit to analyzes if any changes in your business or the law adhere with HIPAA compliance.

Business Associate Agreements: (R) Have unique Omnibus-agreeable contracts with business accomplices who will have admittance to your PHI to guarantee that they will comply with HIPAA.

HIPAA Physical Requirements

• Contingency Operations: (A) Establish techniques to allow recovery of lost data under the adversity rescue plan and backup mode procedures on the occasion of an emergency.
• Facility Security: (A) Deploy policies and procedures so the system and the equipment remain safe from unauthorized physical access, tampering, and theft.
• Access Control and Validation: (A) Set up the legitimate mechanism to control and validate access to stakeholders on the basis of their role or function.
• Records Maintenance: (A) There should be standard policies and procedures to document care, handling, and modifications to the physical components having PHI security concerns.
• Workstations: (R) Ensure policies about what software can/must run and how it will be configured on systems that provide ePHI access.
• Devices and Media Disposal and Re-use: (R) Establish procedures for dumping or disposal of media/devices containing or could have been used for ePHI.
• Media Movement: (A) Engender a retrievable, exact replica of electronic forefended health information, when needed, afore moving of equipment.

HIPAA Technical Specifications

• Identification of unique user: (R) Assign a unique user name or userid or number for detecting and tracking unique user’s identity.
• Emergency Access: (R) Set up procedures for retrieving crucial electronic protected health information during an emergency.
• Automatic Logoff: (A) Implement mechanism for automatic logout after inactivity/idle, session timeout.
• Encryption and Decryption: (A) According to required situation introduce a mechanism to encrypt and decrypt ePHI.
• Audit Controls: (R) Outline defined mechanisms/functioning of hardware, software, and/or technical tools which record and examine ePHI.
• ePHI Integrity: (A) Set guidelines and measures to shield ePHI from inadequate amendment or obliteration.
• Authentication: (R) Device measures to authenticate a person or entity to get legitimate access to electronic protected health information.
• Electronic Protected Health Information Data Transmission Security: (A) Implement technical safeguards against unauthorized access to ePHI which is being transmitted over an electronic communications network.

Conclusion:

If you are going to develop an mHealth solution, considering your organization’s goal, objective and functioning decide whether it falls in the category to be HIPAA compliance or not. Attaining HIPAA compliance is no informal assignment. Understanding the fundamental elements of compliance help your organization to overcome the challenge in an adequate manner. Don’t forget to institute the organizational processes followed by technology implementations. During outlining be sure on who’s responsible, what could be possible breaches, what need to be protected, and how it needs to be protected.