HIPAA Compliance for Developers

HIPAA Compliance for Developers

Breaking down the regulatory issues around building digital health apps for fun and profit.

HIPAA compliant database-as-a-service

HIPAA Compliance is a Brutal Time Suck!

!

“[Building our own HIPAA compliant infrastructure] took upwards of 1,000 person-hours to figure out HIPAA-compliance issues. This will continue to be an ongoing cost for us, because HIPAA is an ongoing law and it changes sometimes. It takes substantial auditing time and money.

TrueVault would save us all that.”

Posted on Hacker News by jph (Unsolicited comment. Not a customer.)


First off, What is HIPAA?Health Insurance Portability and Accountability Act

• HIPAA sets the standard for protecting sensitive patient data.

• Covered Entities and their Business Associates need to protect the privacy and security of protected health information (PHI).

• Developed in 1996. HIPAA was initially created to help the public with insurance portability. In addition, they built a series of privacy tools to protect healthcare data.


What Does HIPAA Require?1.Put safeguards in place to protect patient health information.

2.Reasonably limit use and sharing to the minimum necessary to accomplish your intended purpose.

3.Have agreements in place with service providers that perform covered functions. These agreements (BAAs) ensure that service providers (Business Associates) use, safeguard and disclose patient information properly.

4.Procedures to limit who can access patient health information, and training programs about how to protect patient health information.


The Four Rules of HIPAALike the four horsemen, these are the major pieces that govern what you do and how you do it.

1.HIPAA Privacy Rule

2.HIPAA Security Rule

3.HIPAA Enforcement Rule

4.HIPAA Breach Notification Rule


Developers need to focus on the Technical and Physical

safeguards outlined in the Security Rule.

The Privacy Rule


Addresses the saving, accessing and sharing of

medical and personal information of an individual,

including a patient’s own right to access.

The Security Rule


Outlines national security standards intended to

protect health data created, received, maintained,

or transmitted electronically.

The Security Rule


September 23, 2013

Before Sept 23. Rules applied to hospitals, doctors, clinics, etc. After Sept 23. The rules now apply to anyone that touches PHI. (e.g. an IT company or a mHealth application that provides secure photo-sharing for physicians).

Any company that deals with protected health information (PHI) must ensure that all the required physical, network, and process security

measures are in place and followed.


“Do I need to be HIPAA compliant?”


“Do I need to be HIPAA compliant?”

If you handle PHI then you need to be HIPAA compliant. The HIPAA rules apply to both Covered Entities

and their Business Associates

What is Protected Health Information (PHI)?

• PHI is any information in a medical record that can be used to identify an individual, and that was created, used, or disclosed in the course of providing a healthcare service.

• Includes:

• Medical records

• Billing information

• Health insurance information

• Any individually identifiable health information


Electronic Protected Health Information (EPHI)


All individually identifiable health information that

is created, maintained, or transmitted

electronically.

Covered Entity (CE)


• Anyone who provides treatment, payment and operations in healthcare.

• Includes:

• Doctor’s office, dental offices, clinics, psychologists,

• Nursing home, pharmacy, hospital or home healthcare agency

• Health plans, insurance companies, HMOs

• Government programs that pay for healthcare

• Health clearing houses

Business Associate (BA)


• Anyone who has access to patient information, whether directly, indirectly, physically or virtually.

• Any organization that provides support in the treatment, payment or operations

• Includes:

• IT providers, health applications

• Telephone service provider, document management and destruction

• Accountant, lawyer or other service provider

Business associates have the responsibility to achieve and maintain HIPAA compliance in terms of all of the internal, administrative, and technical safeguards.

Exceptions


• Entities providing data transmission services, including services that involve temporary storage of PHI that is incident to the transmission (e.g. courier services and their electronic equivalents, such as ISPs or telecoms).

While entities that are “mere conduits” for PHI are not Business Associates, the rules emphasize that this exception is narrow.


“Who certifies HIPAA compliance?”


“Who certifies HIPAA compliance?”

The short answer is no one.

Who certifies HIPAA compliance?

• Unlike PCI, there is no one that can “certify” that an organization is HIPAA compliant.

• The Office for Civil Rights (OCR) from the Department of Health and Human Services (HHS) is the federal governing body. HHS does not endorse or recognize the “certifications” made by private organizations.

• The evaluation standard in the Security Rule § 164.308(a)(8) requires you to perform a periodic technical and non-technical evaluation to make sure your security policies and procedures meet security requirements.

• But, HHS doesn’t care if the evaluation is performed internally or by an external organization.


Penalties & Fines• Violations are expensive, to put it mildly.



“How do I become HIPAA compliant?”


“How do I become HIPAA compliant?”The HIPAA Security Rule requires appropriate Administrative,

Physical, and Technical Safeguards to ensure the confidentiality, integrity, and security of protected health information (PHI).

3 Parts to the Security Rule1.Administrative Safeguards

2.Technical Safeguards

3.Physical Safeguards


“required” vs. “addressable”• Some implementation specifications are “required” and others are

“addressable.” Required implementation specifications must be implemented.

• Addressable implementation specifications must be implemented if it is reasonable and appropriate to do so; your choice must be documented.

• It is important to remember that an addressable implementation specification is not optional.


When in doubt, you should just implement the addressable implementation specifications. Most of them are best practices anyway.

Administrative SafeguardsThe administrative components are really important when implementing a HIPAA compliance program; you are required to:

1.Assign a privacy officer

2.Complete a risk assessment annually

3.Implement employee training

4.Review policies and procedures

5.Execute Business Associate Agreements (BAAs) with all partners who handle protected health information (PHI)


Administrative SafeguardsCompanies who can help with the administrative components of a compliance program:

• Accountable -- http://accountablehq.com

• Compliance Helper -- http://www.compliancehelper.com

• Compliancy Group -- http://compliancy-group.com


http://compliancy-group.com

Technical Safeguards1.Access Control - Unique User Identification (required): Assign a unique

name and/or number for identifying and tracking user identity.

2.Access Control - Emergency Access Procedure (required): Establish (and implement as needed) procedures for obtaining necessary ePHI during an emergency.

3.Access Control - Automatic Logoff (addressable): Implement electronic procedures that terminate an electronic session after a predetermined time of inactivity.

4.Access Control - Encryption and Decryption (addressable): Implement a mechanism to encrypt and decrypt ePHI.


Technical Safeguards5.Audit Controls (required): Implement hardware, software, and/or procedural mechanisms that

record and examine activity in information systems that contain or use ePHI.

6.Integrity - Mechanism to Authenticate ePHI (addressable): Implement electronic mechanisms

to corroborate that ePHI has not been altered or destroyed in an unauthorized manner.

7.Authentication (required): Implement procedures to verify that a person or entity seeking

access to ePHI is the one claimed.

8.Transmission Security - Integrity Controls (addressable): Implement security measures to

ensure that electronically transmitted ePHI is not improperly modified without detection until

disposed of.

9.Transmission Security - Encryption (addressable): Implement a mechanism to encrypt ePHI

whenever deemed appropriate.


Physical Safeguards1.Facility Access Controls - Contingency Operations (addressable): Establish (and implement as needed) procedures that allow facility

access in support of restoration of lost data under the disaster recovery plan and emergency mode operations plan in the event of an emergency.

2.Facility Access Controls - Facility Security Plan (addressable): Implement policies and procedures to safeguard the facility and the equipment therein from unauthorized physical access, tampering, and theft.

3.Facility Access Controls - Access Control and Validation Procedures (addressable): Implement procedures to control and validate a person’s access to facilities based on their role or function, including visitor control, and control of access to software programs for testing and revision.

4.Facility Access Controls - Maintenance Records (addressable): Implement policies and procedures to document repairs and modifications to the physical components of a facility which are related to security (e.g. hardware, walls, doors, and locks).

5.Workstation Use (required): Implement policies and procedures that specify the proper functions to be performed, the manner in which those functions are to be performed, and the physical attributes of the surroundings of a specific workstation or class of workstation that can access ePHI.


HIPAA Compliant Hosting Providers can take care of some of the Physical Safeguards for you.

Physical Safeguards6.Workstation Security (required): Implement physical safeguards for all workstations that

access ePHI, to restrict access to authorized users.

7.Device and Media Controls - Disposal (required): Implement policies and procedures to address the final disposition of ePHI, and/or the hardware or electronic media on which it is stored.

8.Device and Media Controls - Media Re-Use (required): Implement procedures for removal of ePHI from electronic media before the media are made available for re-use.

9.Device and Media Controls - Accountability (addressable): Maintain a record of the movements of hardware and electronic media and any person responsible therefore.

10.Device and Media Controls - Data Backup and Storage (addressable): Create a retrievable, exact copy of ePHI, when needed, before movement of equipment.


TrueVault Handles All Technical Requirements


Administrative Safeguards

Technical Safeguards Encryption and Decryption, Key Management, Key Rotation, Access Control, Unique User Identification, Emergency Access, Automatic Logoff, Audit Controls, Mechanism to Authenticate Electronic PHI, Person or Entity Authentication, Transmission Security, Integrity Controls

Physical Safeguards Facility Access Ctrl, Workstation Use and Security, Devices and Media Controls

HIPAA Compliant Hosting

TrueVault

• TrueVault handles both Technical and Physical Safeguards. !

• Develop a healthcare application without building a HIPAA compliant infrastructure. !

• FireHost and AWS have high minimum charges ($1,115 and $1,500) and offer no help with the Technical Safeguards.

How Does TrueVault Fit In?


!• Developers access TrueVault

via a RESTful API and native clients. !

• Typical integration takes days. TrueVault works just like any other API services. !

• TrueVault provides all client-side and server-side functionalities required by HIPAA.

Customer)Backend)Web)Services))

Standard)Database)

TrueVault)(HIPAA)Compliant))

non@PHI)Data)

PHI)Data)(REST)API))

TrueVault Features


JSON Store The TrueVault JSON Store is a lightweight, document-oriented storage system, and enables persistent HIPAA compliant storage of JSON documents.

BLOB Store The TrueVault BLOB (binary large object) Store offers HIPAA compliant

binary storage for any file format. This includes DICOM files (e.g. X-Rays, CT Scans, MRIs), PDFs, scanned medical records, images, and videos.

Encrypted Search Search encrypted data stored in TrueVault. Query (GET) documents by any field, not just the documentId.

TrueVault Features


Browser-to-TrueVault Upload Browser-to-TrueVault direct file upload and download web form. You can upload binary files directly to TrueVault’s BLOB Store using HTML forms.

User Management and Authentication User Management console. You can create and manage users, groups,

and permissions via TrueVault so that PHI never touches your stack. TrueVault provides identity and access management, plus 2-factor

authentication out of the box. Use our identity API for custom access flows or add Sign-In, Sign-Up, and My Account pages in seconds with

our JavaScript user controls.

Encryption and Decryption TrueVault encrypts all at-rest data with AES-256 and stores keys securely. Our infrastructure for healthcare data storage and transmission runs in a separate hosting environment inaccessible by our primary services.

TrueVault Features


Audit Control Every user action and API call is automatically recorded for compliance. An audit log can be searched and retrieved via our API.

Automatic Logoff Configure the automatic user session timeout window via our API or the

Management Console.

Emergency Access Easily add an Emergency Access Request page to your app with a CNAME record. We’ll handle the authentication flow for you, and track activities for compliance. Single-user credentials can also be created via the API for custom emergency workflows.

TrueVault Features


Proactive Monitoring TrueVault’s proprietary anomaly-based detection algorithm will alert you, or your customer, when abnormal user activity is detected.

At-Rest Data Integrity A checksum is computed for every at-rest record, and the integrity of

the data is continuously checked.

Integrity Control and Encryption TrueVault regularly audits the details of our implementation: the certificates we serve, our certificate authorities, and our ciphers. We ensure that browsers and API clients interact with TrueVault over HTTPS only.


"Becoming HIPAA compliant as an early stage organization was a daunting task, until we found TrueVault! Their turn-key API has allowed us to check this box and get back to focusing on our core product and offering."

Edith ElliottCEO Noora Health

Try TrueVault for Free


$0.001 / API call / monthFree for Development

• No credit card required.

• No time limit on the free trial period.

• Unlimited API calls and storage.

• But, no BAA and no insurance.

API Calls Monthly Cost

0 -100,000 $100

101,000 $101

250,000 $250

1,000,000 $1,000

• Unlimited JSON documents

• Unlimited BLOB objects

• Business Associated Agreement

• Privacy/Data Breach Insurance

• Service Level Agreement

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HIPAA Compliance for Developers

Healthcare

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